Background

The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-67, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

On May 2, 2013, we published in the Federal Register (78 FR 25620-25623, Docket No. APHIS-2012-0078) a proposal  1 to amend the regulations by allowing the importation of female squash flowers from Israel into the continental United States under a systems approach that would include requirements for pest exclusion at the production site and fruit fly trapping and monitoring. The female squash flowers would also have to be accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) of Israel with an additional declaration that the female squash flowers have been inspected and found free of quarantine pests.

We solicited comments concerning our proposal for 60 days ending July 1, 2013. We received two comments from members of the public by that date.

One commenter supported the proposed rule. One commenter opposed the proposed rule, citing no finding of a public benefit for importing female squash flowers, a potential slight decrease in the price of the commodity, and an additional cost to the U.S. Government for enforcing compliance with the regulation.

Under the Plant Protection Act (7 U.S.C. 7701 et seq. ), the Animal and Plant Health Inspection Service (APHIS) has the authority to prohibit or restrict the importation of plants and plant products only when necessary to prevent the introduction into or dissemination of plant pests or noxious weeds within the United States. APHIS does not have the authority to restrict imports solely on the grounds of potential economic effects on domestic entities that could result from increased imports.

The commenter expressed concern about the potential introduction of new pests resulting in reduced crop yields, fruit-fly-borne diseases, and increased economic and health costs associated with pesticide use. The commenter also mentioned the lack of provisions to compensate domestic farmers for the harm caused by the failure of importers of female squash flowers to comply with the proposed mitigation measures.

APHIS has determined that the measures outlined in the risk management document that accompanied the proposed rule are sufficient to mitigate the risk of pests being introduced into the United States as a result of the importation of female squash flowers from Israel. The commenter did not provide any evidence that the measures would not be effective. The NPPO of Israel and APHIS will collaborate to ensure that growers and importers comply with the proposed measures, as we do in other import programs.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

This final rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT .

This final rule will amend the regulations to allow, under certain conditions, the importation of female squash flowers ( Cucurbita pepo L.) from Israel into the continental United States. Squash flowers have gained in popularity as an elegant way to garnish dishes, desserts, and salads, and as an ingredient in other dishes. Marketing of commercially grown edible flowers is typically directed to clientele at upscale restaurants.

Farms that solely produce squash flowers are rare. The blossoms are typically a by-product of squash fruit production. Squash is commercially produced throughout the United States, but principally in Michigan, California, Florida, and Georgia.

The Small Business Administration's small-entity standard for U.S farms that produce squash is annual receipts of not more than $750,000. In 2007, the average market value of sales by the 11,821 U.S farms that produced squash was about $17,222, well below the small-entity standard. We infer that by far most farms producing squash, including farms producing squash flowers, are small entities.

Israel is expecting to export 10 metric tons of fresh female squash flowers annually to the United States. We do not know the quantity or value of female squash flower production in the United States, or the quantity or value of female squash flowers imported from other countries. Without basic production and trade information, we are unable to evaluate potential impacts of this final rule.

This final rule allows fresh female squash flowers to be imported into the United States from Israel. State and local laws and regulations regarding female squash flowers imported under this rule will be preempted while the fruit is in foreign commerce. Fresh vegetables are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0406, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

Accordingly, we are amending 7 CFR part 319 as follows:

Overview

The 2014 Farm Bill (Pub. L. 113-79) authorizes the continuation of CRP, including TIP. In general, FSA will continue to implement CRP Continuous sign-up and TIP under the provisions of existing regulations, but this implementation will also include changes to the program required by the 2014 Farm Bill, such as a change in the cropping history required for eligibility. FSA, using its discretionary authority, will offer the opportunity for 1-year extensions to producers for certain existing contracts; FSA will also, as required by the 2014 Farm Bill, allow early outs for certain existing contracts. The 2014 Farm Bill reauthorized CRP through September 30, 2018.

FSA is completing the appropriate NEPA (42 U.S.C. 4321-4347) analysis. FSA will update regulations, software, forms, and handbooks to implement all the changes required by the 2014 Farm Bill. FSA is also updating CRP Fact Sheets and will conduct extensive outreach to ensure that producers are aware of sign-up periods and application requirements. Details of sign-up periods and additional changes to CRP will be announced in separate press releases.

As specified in the 2014 Farm Bill and in the existing regulations, FSA offers CRP continuous sign-up for environmentally sensitive land that is devoted to high priority conservation practices. Continuous sign-up will continue as specified in the existing regulations in 7 CFR part 1410, but will reflect a change to the cropping history requirement as specified in the 2014 Farm Bill.

In general, for cropland to be eligible for enrollment in CRP a cropping history for such cropland is required. The 2014 Farm Bill requires that to be eligible for enrollment in CRP, cropland must have a cropping history or otherwise be considered planted for 4 of the 6 years preceding February 7, 2014, the date of enactment of the 2014 Farm Bill. Therefore, beginning June 5, 2014, for cropland to be eligible for CRP continuous sign-up, the cropland must have a cropping history, or be considered to have been planted, for at least 4 years during 2008 through 2013.

TIP provides financial incentives for retired or retiring owners or operators to transition land enrolled in CRP to beginning or socially disadvantaged farmers or ranchers for the purpose of returning some or all of the land into production, using sustainable grazing or crop production methods in compliance with the required conservation plan. If approved for TIP, the retired or retiring owner or operator will receive CRP payments for an additional 2 years after the CRP contract expires.

The 2014 Farm Bill reauthorized TIP with minor administrative changes. Specifically, the 2014 Farm Bill now allows the retired or retiring owner or operator who transfers the land to a veteran farmer or rancher to be eligible for TIP. Section 2006(b) of the 2014 Farm Bill refers to the definition of “veteran farmer or rancher” in 7 U.S.C. 2279(e): A farmer or rancher who has served in the Armed Forces, as defined in 38 U.S.C. 101(10), and who either has not operated a farm or ranch, or has operated a farm or ranch for not more than 10 years. This effectively means that to be eligible for TIP, the veteran farmer or rancher must also meet the existing definition of a beginning farmer or rancher (found in 7 CFR 1410.2). Consequently, this change does not increase the pool of eligible participants in TIP.

The 2014 Farm Bill authorizes $33 million total for fiscal years 2014 through 2018 to carry out TIP. This was an increase from the $25 million authorized under the 2008 Farm Bill. CCC will restart TIP, subject to this funding limit, and begin an outreach effort about TIP to eligible veteran farmers and ranchers, as well as beginning and socially disadvantaged farmers and ranchers.

CRP contracts covering about 1.8 million acres of general sign-up land are scheduled to expire on September 30, 2014. No CRP general sign-up is scheduled for FY 2014. This document announces that FSA will provide an opportunity for a 1-year extension of CRP contracts scheduled to expire September 30, 2014, that were also originally enrolled under a previous CRP general sign-up and have a CRP contract length of 14 years or less. CRP participants may elect to extend the contract for all or a portion of the land enrolled under the expiring CRP contract. CRP participants that choose to extend CRP contracts for 1 year will be required to file a CRP contract modification to extend the contract expiration. All terms and conditions of current CRP contracts will apply to the contract extension. This 1-year extension opportunity will be available from June 5, 2014, through August 8, 2014. This extension is discretionary and is not required by the 2014 Farm Bill.

Section 2006(a) of the 2014 Farm Bill requires the Secretary to offer producers the opportunity for early termination—“early-outs”—of certain CRP contracts during FY 2015, if those contracts have been in effect for at least 5 years. However, not all CRP contracts will be eligible for early-out even if they meet the 5 years requirement; the 2014 Farm Bill specifies that the following types of land will not be eligible for early-out:

• Filterstrips, waterways, strips adjacent to riparian areas, windbreaks, and shelterbelts;

• Land with an erodibility index of more than 15;

• Land devoted to hardwood trees;

• Wildlife habitat, duck nesting habitat, pollinator habitat, upland bird habitat buffer, wildlife food plots, State acres for wildlife enhancement, shallow water areas for wildlife, and rare and declining habitat;

• Farmable wetland and restored wetland;

• Land that contains diversions, erosion control structures, flood control structures, contour grass strips, living snow fences, salinity reducing vegetation, cross wind trap strips, and sediment retention structures;

• Land located within a federally designated wellhead protection area;

• Land that is covered by an easement under CRP;

• Land located within an average width, according to the applicable Natural Resources Conservation Service field office technical guide, of a perennial stream or permanent water body; and

• Land enrolled under the conservation reserve enhancement program.

The producer may request the early-out, and it will be effective upon approval by the FSA County Office Committee. The start and end dates for requesting the early-out will be determined by the Deputy Administrator for Farm Programs and will be announced later by a news release.

The 2014 Farm Bill did not change the following provisions for prorated rental payment, renewed enrollment, conservation requirements, and liability for contract violation:

If an early-out terminates a CRP contract before the end of the fiscal year for which a CRP rental payment is due, FSA will provide a prorated rental payment covering the portion of the fiscal year during which the CRP contract was in effect.

An early-out will not affect the ability of the owner or operator that requested the early-out to submit a subsequent bid to enroll the land that was subject to the CRP contract into CRP.

If the producer returns land that was subject to a CRP contract to production of an agricultural commodity, the conservation requirements for highly erodible land conservation and wetland conservation under 7 CFR part 12 and 16 U.S.C. Chapter 58, subchapters II and III, will apply.

The early-out does not relieve the producer of liability for a contract violation occurring before the date of the contract termination.

FSA is currently analyzing discretionary changes to CRP authorized by the provisions of the 2014 Farm Bill by preparing a Supplemental Programmatic Environmental Impact Statement (SPEIS), as was announced in a separate notice in the Federal Register on November 29, 2013 (78 FR 71561-71562). However, FSA has determined, in accordance with 7 CFR 799.9(d), “Ensuring That Environmental Factors are Considered in Agency Decisionmaking,” and 40 CFR parts 1500-1508 (the NEPA implementing the regulations of the Council on Environmental Quality) that the continuation of continuous CRP, the restarting of CRP TIP, and a 1-year contract extension for certain expiring CRP contract holders consistent with the current implementing regulations, will not significantly affect the quality of the human environment. Therefore, no environmental assessment or environmental impact statement will be prepared on these specific program provisions as specified in this document.

Background

On August 28, 2013, FSIS published in the Federal Register a document announcing changes that it intended to make in its Salmonella sampling program for raw beef products (78 FR 53017). The Agency requested comment on these changes, with the aim of assessing whether it should alter any of its plans on the basis of the information or data it received.

FSIS announced that it would begin analyzing for Salmonella all samples of raw ground beef, beef manufacturing trimmings, bench trim, and other raw ground beef components that it collects for STEC testing, including raw ground beef products FSIS samples at retail stores and ground beef, trim, and other raw ground beef components FSIS samples at import establishments. FSIS also explained that when it begins analyzing for Salmonella the product collected for STEC analysis, the Agency will also begin analyzing for Salmonella the follow-up samples it collects in response to STEC positive results. FSIS further explained that it is not making any changes to the STEC sampling and testing programs at this time.

FSIS announced that, once the “co-analysis” begins, it would increase the raw ground beef sample portion for Salmonella analysis from 25 grams to 325 grams. FSIS explained that to support an increase in the sample size analyzed, FSIS evaluated the FSIS Salmonella detection method (FSIS Microbiology Laboratory Guidebook Chapter 4.06) using 325 gram samples. Based on this analysis, FSIS expects the increase in the analytical portion size to have at least the same, but likely more of a positive, impact on public health because the likelihood of detecting positive samples increases with the analytical portion size.

FSIS described how it intends to use results generated from its raw ground beef (MT43) and beef manufacturing trimming (MT60) verification sampling programs to estimate the Salmonella prevalence in those products and to develop a new Salmonella performance standard for ground beef product. FSIS explained that the low incidence of Salmonella on beef manufacturing trimmings does not support development of a Salmonella performance standard for those trimmings. FSIS also explained that, because of the limited number of available samples scheduled and collected, the Agency does not believe it is possible to estimate prevalence for Salmonella in raw ground beef components other than beef manufacturing trimmings (such as bench trim).

FSIS explained that it intends to develop a new performance standard that will likely lead establishments producing ground beef to strengthen their own Salmonella control measures. Such changes at establishments will likely have a positive impact on public health.

FSIS also announced that it intends to enumerate samples that confirm Salmonella -positive using the Most Probable Number (MPN) quantitative procedure, and that it will continue to evaluate Salmonella isolates from the screen-positive samples for multi-drug resistance, to serotype the samples, and to use pulsed-field gel electrophoresis (PFGE) to identify specific strains of Salmonella. FSIS explained that, through this analysis, FSIS will determine whether Agency-positive Salmonella results are associated with illnesses or serotypes of human health significance. If FSIS finds that establishments have produced product associated with illness, FSIS will typically conduct an Incident Investigation Team Review or Food Safety Assessment at the establishment.

FSIS also announced in the same document that, except for establishments with results that exceeded the standard for Salmonella in that establishment's most recently completed set (i.e., those establishments in category 3), it would discontinue Salmonella sampling sets for ground beef products at least until it establishes a revised Salmonella performance standard for ground beef. FSIS explained that, when collecting samples for a Salmonella set, FSIS inspection program personnel submit the samples to FSIS laboratories for analysis over a defined number of sequential days of production to complete the sample set.

FSIS stated that it would consider alternatives to set-based testing for Salmonella, including a “moving window” approach to process control, to be put into effect when the revised performance standard is implemented. FSIS explained that under a “moving window” approach, the Agency would evaluate a certain number of sequential results from a single establishment to assess process control. For example, if the Agency chose to evaluate 20 results under the “moving window” approach, it would assess the most recent 20 FSIS results for a particular establishment. FSIS explained that this new approach would allow for on-going scheduled Salmonella sampling, similar to the approach FSIS uses for STEC testing, and would provide FSIS with more flexibility for scheduling sample collection at different establishments. The Agency requested comment on the “moving window” approach.

In addition, FSIS explained that it is considering implementing new sampling of product classes not subject to the Agency's sampling and testing for Salmonella. The Agency stated that it was considering sampling and testing for Salmonella in pork trim, pork parts, ground pork, chicken parts, and lamb carcasses.

FSIS explained that the changes that it announced to its Salmonella sampling procedures would permit it to analyze more samples at the same time at lower cost to the Agency than does the current method. Through this new approach, FSIS will be able to analyze for Salmonella beef manufacturing trimmings and other raw ground beef components at slaughter establishments. Sampling these products will provide FSIS more information about Salmonella at these establishments than FSIS was able to gather through carcass testing.

The final rule “Pathogen Reduction; Hazard Analysis and Critical Control Point (PR/HACCP) Systems,” which FSIS published on July 25, 1996 (61 FR 38805-38989; http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf ), set Salmonella performance standards for establishments producing selected classes of raw meat products, including ground beef, steers and heifers, and cows and bulls (9 CFR 310.25(b)). In 2011, FSIS stopped sampling and testing for Salmonella in steers and heifers and cows and bulls because percent positive findings were very low (less than one percent), and this carcass sampling was expensive for the Agency.

After carefully considering all comments received, FSIS has determined that no changes are needed in the plans it announced in the August 2013 Federal Register document. Thus, on June 29, 2014, FSIS will discontinue Salmonella sampling set procedures in ground beef products (“HC01”), except in those establishments in Category 3. At the same time, FSIS will begin analyzing for Salmonella all raw beef samples it collects for STEC analysis and will increase the raw ground beef sample portion for Salmonella analysis from 25 grams to 325 grams.

Also, consistent with what the Agency announced in the August 2013 Federal Register document, FSIS intends to use the results from its verification sampling program to estimate Salmonella prevalence in raw ground beef and beef manufacturing trimmings and to develop a new Salmonella performance standard for ground beef product. FSIS will announce any new standard in the Federal Register and request comment on it before implementing it. FSIS intends to develop and propose the new standard next fiscal year.

In addition, FSIS announced its Salmonella Action Plan on December 4, 2013. 1 According to the plan, FSIS intends to complete a risk assessment and develop Salmonella performance standards for comminuted poultry and poultry parts this fiscal year and performance standards and, if needed, sampling programs for hog carcasses and pork products next fiscal year.

The following is a summary of the relevant comments received and FSIS's responses.

FSIS received ten comments in response to the August 2013 Federal Register document. The comments were from trade associations, private citizens, consumer advocacy associations, including a joint submission from two consumer advocacy organizations, a large meat processor, and a foreign government.

Comments: Most of the comments supported the proposed changes to procedures for Salmonella verification sampling and testing of raw beef products because the changes will improve Agency efficiencies. In addition, several comments supported the Agency's intent to estimate Salmonella prevalence in raw beef products, to serotype or enumerate positive samples, to identify specific strains of Salmonella, and to develop a new Salmonella performance standard for ground beef.

Comment: One private citizen opposed FSIS verification sampling and testing for Salmonella in raw beef products because of recent research suggesting that Salmonella may naturally occur in the lymph nodes of cattle. According to the commenter, this detail makes it impossible for establishments to completely eliminate Salmonella from any raw beef product. The commenter recommended that, rather than focusing on verification sampling at the establishment, FSIS focus its resources on researching pre-harvest controls for Salmonella in cattle and educating consumers on how to properly handle and cook raw beef products.

Response: FSIS collects samples of meat and poultry products from an establishment for pathogen testing to verify whether the establishment is effectively addressing the pathogen. When FSIS collects product for Salmonella analysis as part of a set, FSIS verifies whether the establishment is maintaining process control in slaughter or certain processing operations. FSIS uses the results of these and other verification tasks to guide policy development and focus Agency resources on those activities that will best protect public health.

In May 2010, FSIS issued guidance to beef slaughter establishments on pre-harvest management controls for reducing Escherichia coli ( E. coli ) O157:H7 shedding in beef cattle. 2 FSIS is updating this guidance to include other STEC and intends to make the updated guidance available to the establishments soon. Similarly, in November 2011, FSIS met with stakeholders to discuss pre-harvest pathogen control strategies for reducing prevalence of STEC and of Salmonella in and on cattle (76 FR 63901; Oct. 14, 2011). In addition, FSIS conducts multiple consumer education campaigns to inform the American public of the proper methods for handling and cooking meat and poultry, so that any potential food-safety hazard is reduced to a minimum. 3

Comment: A large meat processor generally opposed FSIS verification sampling and testing of portioned fine and coarse ground beef products that are ground at a primary establishment and subsequently portioned at a second establishment because sampling and testing of product from the second establishment is potentially duplicative.

Response: FSIS collects samples of ground product at establishments that grind product or form patties. FSIS does not collect samples of ground beef products for E. coli O157:H7 (or other STEC) analysis at establishments that only pack or portion and do not grind or form patties. When FSIS begins analyzing all raw beef samples collected for STEC analysis for Salmonella, FSIS would also analyze any raw ground beef product samples (e.g., formed raw beef patties) collected for E. coli O157:H7 for Salmonella.

Comment: Two trade associations requested additional information on the protocol for obtaining the larger 325-gram analytical portion used for Salmonella testing.

Response: FSIS inspection program personnel will continue to collect samples of raw beef products for FSIS verification testing using the collection protocols outlined in FSIS Directive 10,010.1  4 and associated FSIS Notices. FSIS has determined that the amount of product inspectors currently collect (about 2 lb or 907 g) will provide the FSIS laboratories with sufficient product to analyze the samples using the larger analytical portion (325 g) for both Salmonella and STEC.

Comment: A trade association and a large meat processor requested that the Agency consider and make note of the larger portion for Salmonella analysis when reporting program results because the larger analytical portion will likely yield more positive results.

Response: When FSIS begins posting on its Web page the results obtained using the larger analytical portion, FSIS will note that the results are from samples it analyzed using the larger portion size. In addition, the Agency will report periodically to each establishment whose product the Agency collects the establishment's test results compared with industry-wide results. FSIS will also post aggregate results of this testing as part of its quarterly report on Salmonella.

Comment: Another trade association suggested that FSIS evaluate whether increasing the analytical portion from 25 to 325 grams increases the likelihood of detecting Salmonella positive samples.

Response: As noted above, based on the analysis discussed in the 2013 Federal Register document, FSIS expects the increase in the analytical portion size to have at least the same, but likely more of a positive impact on public health because the likelihood of detecting positive samples increases with the analytical portion size.

Comment: One trade association noted that many of its members supply raw beef products to the Agricultural Marketing Service (AMS) for various Federal food and nutrition assistance programs. The association asked FSIS to coordinate with AMS on related sampling protocol requirements to ensure a seamless transition.

Response: FSIS has notified AMS of its intent to make changes in its Salmonella verification sampling program for raw beef products.

Comment: The consumer group joint submission stated that FSIS failed to address two critical statistical requirements when estimating prevalence of Salmonella in ground beef: the sampling must be representative of population and the sampling must provide desired precision.

Response: The statistical sampling design for FSIS's raw ground beef verification sampling program is detailed in the Report on the Food Safety and Inspection Service's Microbiological and Residue Sampling Programs (FSIS, 2011). 5 The sampling design is volume-weighted (i.e., probability is proportional to sample size) to provide for sampling that is representative of national production volume.

In 2012, FSIS determined that its MT43 sampling program is sufficiently representative and provides the needed precision to compute prevalence of E. coli O157:H7 in raw ground beef. 6 Moreover, FSIS expects that Salmonella will occur in raw beef products at a rate higher than that for E. coli in raw ground beef. For these reasons, FSIS's ground beef verification sampling program will adequately support the development of an estimate of the prevalence of Salmonella in raw beef products.

Comment: A trade association requested that FSIS also conduct a risk assessment that addresses the risk that Salmonella presents in pork, chicken, turkey, and ready-to-eat products.

Response: As previously stated, FSIS intends to complete a risk assessment for Salmonella in comminuted poultry and poultry parts this fiscal year. FSIS will develop additional risk assessments concerning Salmonella and other products as necessary, for example, should FSIS decide to evaluate whether to propose performance standards for additional products.

Comment: Because beef products have the greatest seasonal variation among the products subject to FSIS verification sampling and testing, several industry trade associations and a large meat processor asked that FSIS ensure it has data from at least a 12-month period before conducting the risk assessment and developing a performance standard.

Response: As the new ground beef data are collected, FSIS will evaluate the suitability of those data for use in performance standard development. It should be noted, however, that the current ground beef performance standard was developed using approximately 7 months of data. 7

Comment: Several comments requested a more detailed explanation of how the “moving window” approach will work. More specifically, the joint submission requested additional information on how big the window would be, how often the Agency would sample product at a single establishment, and the Agency's analytical capacity to adequately take such an approach. An industry trade association requested that FSIS develop a written protocol for this approach and make the protocol available for review and comment prior to implementation.

Response: As explained in the August 2013 Federal Register document, FSIS intends to take a “moving window” approach when scheduling sampling and evaluating results generated by its Salmonella verification testing program for ground beef products under a new performance standard. With a “moving window” approach, FSIS will evaluate a predetermined number of sequential results for ground beef product from a single establishment to assess process control. The size of the moving window and the threshold for positives within that window will be included in the performance standard developed. At the same time it announces the new performance standard for raw ground beef, FSIS will detail its plans for the new approach in the Federal Register and consider any comments received on it prior to implementation. FSIS is considering using this approach for all Salmonella performance standards and will provide more explanation of how the approach will work for all classes of product.

Comment: Several trade associations requested clarification on how the Agency will respond with follow-up sampling in the event of a positive Salmonella result when the sample is negative for STEC.

Response: As FSIS explained in the 2013 Federal Register document, because FSIS does not typically consider Salmonella an adulterant in raw beef, when FSIS begins analyzing samples collected for STEC analysis for Salmonella, FSIS will not routinely conduct follow-up sampling in response to a single positive Salmonella result. However, if FSIS Salmonella testing data from an establishment show a high number of positives, high levels of Salmonella for each positive, or serotypes of human health significance, FSIS may perform follow-up testing or conduct a for-cause Food Safety Assessment that includes follow-up testing or take other appropriate actions, such as additional sanitary dressing verification procedures, at the establishment that produced the product.

Comment: A foreign government requested clarification on regulatory control actions the Agency will take when raw beef product imported into the United States is sampled by FSIS at the port of entry and tests positive for Salmonella.

Response: As stated above, Salmonella is not an adulterant in raw meat products. Therefore, a positive test result for Salmonella in imported raw beef product sampled by FSIS import inspection personnel would not result in regulatory control actions at port-of-entry.

FSIS does not collect imported raw products for Salmonella analysis. FSIS stated that it intended to begin testing for Salmonella imported raw beef products it samples for STEC in the August 2013 Federal Register document. On June 29, 2014, FSIS will begin analyzing for Salmonella all imported raw beef samples it collects for STEC analysis. FSIS will post aggregate results of this testing on the FSIS Web site as part of its quarterly report on Salmonella. In addition, FSIS will use enumeration and serotype data of this testing to identify trends within the sampling data, to determine whether an isolate has a historical association with human illness, and to identify clusters of patterns.

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.)

Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at (202) 720-2600 (voice and TTY).

To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY). USDA is an equal opportunity provider and employer.

FSIS will announce this document online through the FSIS Web page located at http://www.fsis.usda.gov/federal-register .

FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/subscribe . Options range from recalls to export information to regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

History

On March 18, 2014, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to amend Class E airspace at, Newnan Coweta County Airport, Newnan, GA. (79 FR 15065). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9X dated August 7, 2013, and effective September 15, 2013, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface at Newnan Coweta County Airport, Newnan, GA. A segment is added from the 6.5-mile radius of the airport to 14 miles southeast of the airport to support new Standard Instrument Approach Procedures, and for continued safety and management of IFR operations at the airport. The geographic coordinates of the airport also are adjusted to be in concert with FAA's aeronautical database.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Newnan Coweta County Airport, Newnan, GA.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

History

On March 18, 2014, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to amend Class E airspace at Elkin Municipal Airport, Elkin, NC, (79 FR 15067). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9X dated August 7, 2013, and effective September 15, 2013, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 9.3-mile radius of Elkin Municipal Airport, Elkin, NC. Airspace reconfiguration is necessary due to the development of the RNAV (GPS) RWY 7 approach and for continued safety and management of IFR operations at the airport. The geographic coordinates of the airport also are adjusted to be in concert with FAA's aeronautical database.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Elkin Municipal Airport, Elkin, NC.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Background

The Entity List notifies the public about entities that have engaged in activities that could result in an increased risk of the diversion of exported, reexported or transferred (in-country) items to weapons of mass destruction (WMD) programs. Since its initial publication, grounds for inclusion on the Entity List have expanded to include activities sanctioned by the State Department and activities contrary to U.S. national security or foreign policy interests, including terrorism and export control violations involving abuse of human rights. Certain exports, reexports, and transfers (in-country) to entities identified on the Entity List require licenses from BIS and are usually subject to a policy of denial. The availability of license exceptions in such transactions is very limited. The license review policy for each entity is identified in the license review policy column on the Entity List and the availability of license exceptions is noted in the Federal Register notices adding persons to the Entity List. BIS places entities on the Entity List based on certain sections of part 744 (Control Policy: End-User and End-Use Based) of the EAR.

The End-user Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and all decisions to remove or modify an entry by unanimous vote.

This rule implements the decision of the ERC to add twenty-six persons under thirty-one entries to the Entity List on the basis of § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The thirty-one entries added to the Entity List consist of three entries in China, seven entries in Hong Kong, six entries in Lebanon, and fifteen in the U.A.E.

The ERC reviewed § 744.11(b) (Criteria for revising the Entity List) in making the determination to add these twenty-six persons to the Entity List. Under that paragraph, persons for whom there is reasonable cause to believe, based on specific and articulable facts, have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States, and those acting on behalf of such persons, may be added to the Entity List. Paragraphs (b)(1) through (b)(5) of § 744.11 include an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States.

The twenty-six persons being added have been determined by the ERC to be involved in activities that are contrary to the national security or foreign policy interests of the United States, specifically the activities described under paragraphs (b)(1), (b)(2) and/or (b)(4) of § 744.11.

The ERC has determined that two persons being added to the Entity List under the destination of Hong Kong have been involved in activities contrary to the national security and foreign policy interests of the United States, specifically the activities described under paragraph (b)(4)(Preventing Accomplishment of an End-Use Check) of § 744.11 of the EAR. The ERC has reasonable cause to believe that Sinovac Technology Limited and Bing Lu have been involved in the reexport of sensitive U.S.-origin items to unauthorized end-users and have prevented the accomplishment of an end-use check by or on behalf of BIS.

The ERC also determined that the following nineteen persons being added to the Entity List under the destinations of Lebanon and the U.A.E. have been involved in activities contrary to the national security and foreign policy interests of the United States, specifically the activities described under paragraph (b)(1)(Supporting persons engaged in acts of terror) of § 744.11 of the EAR. The ERC has reasonable cause to believe that Lebanon-based New Intelcom, Power S.A.L., Zener Lebanon, and Wave Tech, as well as U.A.E.-based Wave Tech Computers, Wave Tech Group, Source Com, al Tawasul al Arabi Net Systems, Zener Marine, Zener Navcom, Zener One Net, Zener Electrical & Electronics, Zener Electronics Services, Ivan Desouza, Girish Purushothama, Taha Mansur and Ahmad Assad Fa'ur, as well as al Ajwa al Tiqniah, and Husayn Fa'ur have attempted to procure U.S. technology on behalf of persons involved in activities contrary to the national security and foreign policy interests of the United States. Specifically, these persons have been involved in supplying U.S.-origin items to persons designated by the Secretary of State as Foreign Terrorist Organizations without the required authorizations. Two of the persons, al Ajwa al Tiqniah and Husayn Fa'ur, are being listed under addresses in both Lebanon and the U.A.E. These two additional addresses account for the twenty-seventh and twenty-eighth entries for the twenty-six persons being added to the Entity List in this rule.

Finally, the ERC determined that the following five persons being added to the Entity List under the destinations of Hong Kong and China have engaged in actions contrary to the national security and foreign policy interests of the United States, specifically the activities described under paragraph (b)(2) of § 744.11 of the EAR (Actions that could enhance the military capability of, or the ability to support terrorism of governments that have been designated by the Secretary of State as having repeatedly provided support for international acts of terrorism). Specifically, these persons have engaged in actions that could enhance the capabilities of the Syrian government. These persons are also being added because their overall conduct and deceptive practices pose a risk of ongoing violations of the EAR. These persons, Kinglead Electronic Co., Ltd., JLD Technology Hong Kong Co., Ltd., Synergy Express Ltd., BVI Electronics and Alpha Lam, participated in a complex and layered network that diverted U.S. origin items through China and Hong Kong and engaged in deceptive actions, including shifting/circuitous routes and false or omitted information on shipping documentation, in an attempt to conceal their activities. These persons, while not under the same ownership or management, are interrelated and arranged for the transshipment of items subject to the EAR to end-users associated with the government of Syria and knowingly engaged in violations of U.S. export control laws. Three of the persons, Kinglead Electronics Co., Ltd., Alpha Lam, and BVI Electronics, are listed under addresses in both Hong Kong and China. These three additional addresses account for the twenty-ninth, thirtieth and thirty-first entries for the twenty-six persons being added to the Entity List in this rule.

Pursuant to § 744.11(b)(1), (b)(2), and (b)(4) of the EAR, the ERC determined that the conduct of these twenty-six persons raises sufficient concern that prior review of exports, reexports, or transfers (in-country) of items subject to the EAR involving these persons, and the possible imposition of license conditions or license denials on shipments to the persons, will enhance BIS's ability to prevent violations of the EAR.

For the twenty-six persons recommended for addition, the ERC specified a license requirement for all items subject to the EAR and a license review policy of presumption of denial. The license requirements apply to any transaction in which items are to be exported, reexported, or transferred (in-country) to any of the persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule.

This final rule adds the following twenty-six persons under thirty-one entries to the Entity List:

In addition to the Entity List changes described above, this final rule also updates the authority for part 730 (15 CFR part 730) because of the publication of the Notice of May 7, 2014, Continuation of the National Emergency With Respect to the Actions of the Government of Syria, 79 FR 26589 (May 9, 2014), which resulted in a change to the legal authority for part 730 of the EAR. This change is purely procedural and makes no changes other than to revise the CFR authority paragraph in part 730 for the purpose of making the authority citations current. It does not change the text of any section of part 730, nor does it alter any right, obligation or prohibition that applies to any person under the EAR.

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export or reexport, on June 5, 2014, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR).

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 8, 2013, 78, 2013, 78 FR 49107 (August 12, 2013), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to Jasmeet_K._Seehra@omb.eop.gov , or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. ( See 5 U.S.C. 553(a)(1)). BIS implements this rule to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in country) to the persons being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, then entities being added to the Entity List by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, because these parties may receive notice of the U.S. Government's intention to place these entities on the Entity List if a proposed rule is published, doing so would create an incentive for these persons to either accelerate receiving items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, or to take steps to set up additional aliases, change addresses, and effect other measures to try to limit the impact of the listing on the Entity List once a final rule was published. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

5. For the updated statement of legal authority for the EAR change, the Department finds that there is good cause under 5 U.S.C. 553(b)(3)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This change only updates the legal authority citation for part 730. It clarifies information and is non-discretionary. This change does not alter any right, obligation or prohibition that applies to any person under the EAR. Because this revision is not a substantive change, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness required by 5 U.S.C. 553(d) is not applicable because this change is not substantive. Because neither the Administrative Procedure Act nor any other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable.

Accordingly, parts 730 and 744 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:

Background

The Integrated Coastal and Ocean Observation System Act of 2009 (Pub. L. 111-11) (ICOOS Act or Act) (codified at 33 U.S.C. 3601-3610) directs the President, acting through the National Ocean Research Leadership Council (Council), to establish a National Integrated Coastal and Ocean Observation System (System). The System must “include[] in situ, remote, and other coastal and ocean observation, technologies, and data management and communication systems, and [be] designed to address regional and national needs for ocean information, to gather specific data on key coastal, ocean, and Great Lakes variables, and to ensure timely and sustained dissemination and availability of these data.” 33 U.S.C. 3601(1). Another purpose of the System is “to fulfill the Nation's international obligations to contribute to the Global Earth Observation System of Systems and the Global Ocean Observing System.” 33 U.S.C. 3601(1) and 3603(a).

The System is built upon a national-regional partnership, with contributions from both Federal and non-Federal organizations, promoting the quick and organized collection and distribution of ocean, coastal, and Great Lakes data and data products to meet critical societal needs. System data is used by both governmental and non-governmental concerns, to, among other things, “support national defense, marine commerce, navigation safety, weather, climate, and marine forecasting, energy siting and production, economic development, ecosystem-based marine, coastal, and Great Lakes resource management, public safety, and public outreach training and education.” It is also used to promote public awareness and stewardship of the Nation's waterways, coasts and ocean resources, and to advance scientific understanding of the use, conservation, management, and understanding of healthy ocean, coastal, and Great Lake resources. 33 U.S.C. 3601(1)(A)-(C).

The ICOOS Act directs the Council to establish or designate an Interagency Ocean Observation Committee (IOOC). In 2010, the Joint Subcommittee on Ocean Science and Technology (JSOST), acting on behalf of the Council, established the IOOC. The IOOC replaced, and assumed and expanded the role of its predecessor, the Interagency Working Group on Ocean Observations, which was originally established by the JSOST under the Ocean Action Plan.

Under the ICOOS Act, the IOOC must “develop contract certification standards and compliance procedures for all non-Federal assets, including regional information coordination entities, to establish eligibility for integration into the System.” 33 U.S.C. 3603(c)(2)(E). To create the certification criteria, the IOOC chartered two working groups consisting of subject matter experts on IOOS data partners and regional entities to draft recommended certification criteria. The recommended draft criteria were approved by the IOOC in October 2011 and released for public input. After a sixty-day public comment period and adjudication of public input, the IOOC drafted final certification criteria.

In developing certification criteria, the IOOC focused on identifying the governance and management criteria a RICE—organizations that coordinate regional observing efforts; manage and operate observing assets; manage and distribute data; and engage user groups in product development—must have in place to allow NOAA to coordinate non‐federal assets for the purposes of the ICOOS Act. The IOOC certification standards ensure the necessary policies, standards, data, information, and services associated with eligibility for integration into the System are appropriately established, coordinated, overseen and enforced.

This rule establishes the criteria and procedures for how RICEs can apply and become certified for and integrated into System. Integration into the System formally establishes the role of the RICE and ensures that the data collected and distributed by the RICE are managed according to the best practices, as identified by NOAA.

Additionally, under the ICOOS Act, employees of RICEs that NOAA has certified and incorporated into the System who gather and disseminate information under this Act are, for the purposes of determining liability arising from the dissemination and use of observation data, considered to be part of NOAA. In other words, they are federal employees for the purposes of tort liability relating to their work directly related to the System. Only those non-federal entities that agree to meet the standards established under the process described in the ICOOS Act, and that are designated by NOAA as certified entities in the System, will be considered as “certified” for purposes of these regulations.

This rule satisfies the ICOOS Act requirement that NOAA, as the lead Federal agency for implementing the System, “promulgate program guidelines to certify and integrate non-federal assets, including regional information coordination entities, into the System.” 33 U.S.C. 3603(c)(3)(C). Accordingly, it details the compliance procedures and requirements for certifying RICEs that satisfy the IOOC-approved certification standards.

Among other things, to become certified, RICEs must provide NOAA with information about their organizational structure and operations, including capacity to gather required System observation data. They must also document their ability to accept and disburse funds and to enter into legal agreements with other entities. RICEs must have by-laws, accountability measures governing boards and an explanation of how they are selected, and be able to provide information about RICE diversity, user feedback processes, and transparency. Moreover, RICEs must submit to NOAA a strategic operation plan to ensure the efficient and effective administration and operation of programs and assets to support the System, and agree to and actually work cooperatively with other governmental and non-governmental entities to the benefit of the System. Importantly, an application for certification must include a description of the RICE's management of ongoing regional system operations and maintenance. The RICE must illustrate its standard operating procedures for ensuring the continued validity and maintenance of equipment used; strategies to enhance the System. Additionally, a RICE must also provide a Data Management and Communications Plan documenting how the RICE maintains and controls data quality and distribution. Certification lasts for five years, after which time a certified RICE must apply for re-certification.

These regulations apply to the certification of RICEs only. Further regulations will be developed by NOAA to provide certification for other non-federal assets that do not meet the definition of RICEs.

The Administrative Procedure Act (APA) notice-and-comment process (5 U.S.C. 553) contemplates that changes may be made to the proposed rule without triggering an additional round of public notice and comment so long as the changes are “in character with the original scheme” and are of a type that could have been reasonably anticipated by the public (i.e., a logical outgrowth of the proposal or comments received) (Foss v. National Marine Fisheries Service, 161 F.3d 584, 591 (9th Cir. 1998); Chemical Mfrs Ass'n v. United States Environmental Protection Agency, 870 F.2d 177 (5th Cir. 1989). The differences from the proposed rule text, published in July 2013 (78 FR 39638) and this final rule, including the basis for changes, are summarized as follows:

A. NOAA added a definition of “Equipment” to § 997.1 to clarify the extent of requirement § 997.23 (d)(4)(i). The new language defines equipment “as a tangible asset that is functionally complete for its intended purpose and has a capital cost of over $5000. Both individual sensors and collections of sensors on a platform are considered equipment and are subject to the $5000 minimum cost.”

B. NOAA revised § 997.13(c) to now require a RICE to notify NOAA only when substantive changes are made to its organizational structure or Strategic Operational Plan, rather than when any changes are made to the details of the structure or Plan as published in the proposed rule. There were a number of comments submitted that stated the proposed language would be onerous for a RICE. NOAA's intention with this requirement is to be notified and approve significant changes to the RICE's management and operational practices, not to be involved in the day to day operations of the RICE.

C. NOAA revised § 997.15(a) to remove the language allowing NOAA to conduct an audit without notice, and to now indicate that NOAA will work with the RICE on the timing and process for the audit. The intention of the audit is not punitive, but more evaluative and is consistent with language in the ICOOS Act requiring that NOAA, as the lead federal agency for the System, shall develop and implement a process for the periodic review and evaluation of the RICEs (Sect. 12304(c)(3)(H)). NOAA's desire is to work with the RICE to review and evaluate the RICE's procedures with a goal to improve effectiveness and maintain credibility.

D. NOAA revised § 997.15(c) to extend the time available to request in writing that NOAA reconsider its intent to decertify the RICE or notify NOAA in writing of the corrective action(s) taken, from 30 days to 45 days.

E. NOAA added language to § 997.21(b)(3) to clarify that if a RICE has a conflict of interest policy that requires a Board member recuse themselves from funding decisions only when the decision may result in the Board member or a direct family member would benefit financially. NOAA recognizes that the ocean and coastal observing community is small and the proposed language would unnecessarily restrict Board member participation in decision-making if interpreted broadly.

F. NOAA revised § 997.23(d)(1) and (2) to delete the references to products and services that the system will deliver. NOAA received several comments stating that the focus of the Strategic Operational Plan should be on the process and desired outcomes, not the assets, products, and deliverables. NOAA agrees that the describing the RICE's processes to deliver quality data and desired outcomes is more valuable than specific products and services, that may change over the five year duration of certification.

G. NOAA revised § 997.23(d)(4)(i-ii) to clarify its requirement for the calibrating validating, operating, and maintaining equipment owned and/or operated by the RICE, and for maintaining equipment inventories, shipping logs and instrument history logs for equipment owned and/or operated by the RICE. NOAA agrees with the comments on the subjective nature of the word “ensure” and has deleted this language. NOAA has also defined equipment in § 997.1, clarifying the extent of the requirement. NOAA's intent is that for assets owned and/or operated by the RICE, the RICE should describe a standard operating procedure for equipment maintenance according to best practices. NOAA's intent is not to dictate the required actions of the RICE, only that the RICE must have a standard operating procedure in place. For assets financially supported by the RICE, fully or partially, but operated by a subcontractor, the RICE should instruct subcontractors to follow best practices and should mandate that equipment maintenance reports should be available periodically or by request.

H. NOAA revised § 997.23(f)(3) to add language clarifying that a RICE is not responsible for performing or describing the quality control procedures for data the RICE obtains from a federal data source. NOAA received several comments stating that it would be unreasonable to require RICEs to perform additional quality control procedures on data federal agencies have deemed suitable for public use. While NOAA's intention is that all the data made available by the RICE is quality controlled, it does not see the necessity of applying additional quality control procedures to data these agencies have distributed for use. NOAA added language to clarify that the RICE must use QARTOD quality control procedures for those data with approved QARTOD manuals. This requirement is consistent with the ICOOS Act requirement that NOAA shall implement protocols and standards approved by the IOOC. Lastly, NOAA deleted the examples of different procedures that may be used in the quality control. For variables without documented QARTOD procedures, the quality control procedures are subject to the judgment of the RICE until QARTOD standards become available.

I. NOAA deleted the requirement that a RICE outline their plan and strategies for diversifying their funding sources and opportunities (proposed as § 997.23(g)(2). NOAA received numerous comments that this requirement was not relevant to integrating a RICE into the System. Although NOAA encourages certified RICEs to pursue diversified funding sources and opportunities, it agrees that this requirement was not relevant to being integrated into the System and NOAA's intent is that the certification is not connected to any specific funding opportunities or existing awards.

J. NOAA revised § 997.23(d)(3) and § 997.23(f)(1)(i) to allow a RICE to identify more than a single individual for each of the positions described in these sub-sections. NOAA received several comments that not all RICEs have a single individual responsible for observations system management across the region and/or data management across the region. Although NOAA has eliminated the limit on the number of individuals a RICE may identified for each of these positions, these individuals must still satisfy the requirements listed in § 997.26(c) to be considered employees of a RICE as defined in the rule.

K. NOAA revised § 997.25(c) to clarify that a RICE only needs to submit to NOAA the documentation on its annual operating and maintenance costs upon request. NOAA recognizes the additional reporting burden that an annual reporting requirement would impose and has modified its approach, while still maintaining NOAA's ability for fiscal oversight as required in the Act.

NOAA published the Notice of Proposed Rulemaking on July 2, 2013 soliciting public comments until August 1, 2013. All written and verbal comments received during the public comment period were compiled and grouped into eight categories. Similar comments from multiple submissions have been treated as one comment for purposes of response. NOAA considered all comments and, where appropriate, made changes that are reflected in this final rule. Several commenters expressed concern about the rule under the Regulatory Flexibility Act and those comments are addressed further in the “Classification” section below. Substantive comments received are summarized below, followed by NOAA's response.

Comment 1: Many Governing Board members have direct interest in the operations of the RA. If the rule is interpreted so that Board members whose institutions receive any funding from the RA would have to recuse themselves on any funding decisions, then it would be impossible to achieve a quorum. Perhaps the conflict of interest could be defined as applying to a council member receiving funds that benefit their own financial situation or that of their family members.

Response 1: NOAA agrees that the definition of the term “conflict of interest” may have the potential to create unintended consequences, and has revised the term at § 997.21(b)(3) to indicate that a conflict of interest occurs when actions benefit a Board member's financial situation or that of their family members.

Comment 2: We request more clarity on definition of “solicits and receives advice on participant diversity, etc.” The requirements stated here seem redundant with requirements which follow in (b)(5)(iii) with the exception of the term “advice.” This paragraph also lacks supporting guidance about what would be considered sufficient documentation to demonstrate compliance.

Response 2: The objective of the requirement to solicit and receive advice on participant diversity is to show that the organization is actively soliciting feedback on their priorities and organizational structure. This requirement is different from the requirements in § 997.21(b)(5)(iii),in that the requirement in § 997.21(b)(3) seeks information on how the RICE solicits their partners for feedback on the RICE organizational structure, whereas the requirement in § 997.21(b)(5)(iii) asks for feedback to gauge the effectiveness of the organization.

When possible, NOAA has provided supporting guidance about what it considers sufficient documentation for approval within this rule, particularly when it considers doing so critical to defining the requirement. In addition, NOAA will publish guidance on complying with the requirements when the Final Rule is published. For this particular requirement, there is no “standard” for approval other than describing how and with what frequency the RICE solicits and receives advice.

Comment 3: Establishing a membership policy that “strives for diversity” is something that is difficult to demonstrate aside from a statement to the effect. This is an example of a requirement that appears to be outside the scope of necessary elements for certification. If that is not the case, the proposed rule must be modified to define “diversity” clearly and provide more information about the minimum necessary requirements.

Response 3: The rule identifies “strives for organizational diversity” as including intra-regional representation and addresses interests from both the public and private sectors. The objective of this requirement is to ensure that a RICE avoids the establishment of a limited and restricted organization that addresses a narrow set of user needs. This is consistent with the ICOOS Act language that states a RICE shall work cooperatively with a variety of entities and consider the needs of multiple users within the region. Because this is clear in this final rule, no additional language is needed.

Comment 4: The requirements for the SOP could be streamlined as some pieces of information are requested multiple times. Both the Development Strategy and the Budget Plan ask for information regarding how the RAs make decisions to support the system and for guiding funding decisions. Recommendation: Combine the elements for the Development Strategy and the Budget Plan together to make a more streamlined and coherent document.

Response 4: While § 997.23(e)(1) and § 997.23(g)(3) are logically related, each guideline asks for different levels of detail. § 997.23(e)(1) asks for the RICE to describe an approach for prioritizing new and possibly competing priorities. § 997.23(g)(3) asks the RICE for a budget plan which explains/defends the RICE's decisions for funding based on RICE priorities. For this reason, NOAA makes no changes to the proposed language.

Comment 5: As written, there are many requirements that are excessive or in need of clarification to demonstrate they are not excessive in application to RICEs that have a mix of assets supported financially by different sources. The elements required for certification must only be those necessary to achieve the stated purpose of the proposed rule: To integrate RICEs into the National Integrated Coastal and Ocean Observation System.

Response 5: NOAA maintains that the rule represents the minimum requirements for certification and integration into the System, based on the ICOOS Act language and the approved IOOC certification criteria. As part of the rule development process, NOAA performed a review of existing RICE documentation and operating procedures, and found that those documents can be reasonably adapted to meet the requirements written in the rule.

Comment 6: The focus of the Strategic Operational Plan (SOP) should be on the process and desired outcomes, not the assets, products, and deliverables. It is too restrictive and binding to presume that specific products should/will be delivered. Instead, develop SOPs that document processes, such as describing approaches to ensure documentation of QA/QC procedures in metadata.

Response 6: NOAA agrees with the comment that the focus of the Operational Plan should be on the process and desired outcomes. The intent of the Operational Plan is to identify, at a high-level, how the RICE manages and operates the integrated system to achieve the desired outcomes. NOAA agrees that over the five year duration of certification, the assets, products, and deliverables that contribute to the system may change, and new approaches may be preferred to meet its objectives. NOAA's intent is that the RICE clearly identify the processes it has in place to achieve its desired outcomes, and amended the text in § 997.23(d)(1) and (2) accordingly.

Comment 7: This rule requires identification of the individuals responsible for observations system management and data management. Not all regional associations have a single individual who fills this role, which often is shared among a number of people. The certification, and therefore indemnification, process should acknowledge that NOAA has allowed regional association structures to develop that are best for each region. This section should be clarified to accommodate the current operational model and many RAs.

Response 7: NOAA accepts that RICE structures will vary; and has revised the rule to state that, for the purposes of indemnification and accountability, a RICE shall identify the individual(s) responsible for the coordination and management of observation data across the region, and as applicable, the individual(s) for observations systems management across the region. These individuals must still satisfy the requirements listed in § 997.26(c) to be considered employees of a RICE as defined in the rule.

Comment 8: Personnel evaluation (Rice Management & Data Manager) should not be part of certification.

Response 8: The ICOOS Act mandates that the RICE develop a strategic operational plan that ensures “effective administration” of programs and assets, “pursuant to standards approved by the Council”. The primary purpose of this guideline is to ensure that (1) the RICE has a process in place for evaluating the capabilities of key personnel and (2) the people hired can perform the duties required. We do not believe that requesting a CV is excessive as Federal agencies routinely require CVs in grant proposals submissions, federal advisory committee nominations, etc., and therefore is not adopting the commenter's suggestion.

Comment 9: In section 997.23(d)(4), an active maintenance oversight program would burden operators with submitting detailed maintenance records and protocols and would be a significant new burden that may result in fewer assets and data streams being available to the System. This requirement would be too labor intensive for the description of minimal anticipated efforts and costs associated with certification outlined under Regulatory Flexibility Act section. Furthermore, the rules should be clarified to define what is meant by “ensure” and also provide an example of how the RICEs are to comply with this provision. RAs should be given flexibility in how they ensure that those responsible for managing hardware owned and operated by the RA (even partially) be calibrated, validated, operated, etc. For instance, it should be specified that providing links to established procedures addressing these issues at the operators' institutions is sufficient to meet this requirement.

Response 9: NOAA has amended the rule based on reviewers' comments of the subjective nature of the word “ensure” by removing the reference to “ensuring that those responsible for managing hardware” from this rule and simplifying the language in section 997.23(d)(4) to describe the standard operating procedures used for quality assurance processes. An example of how the RICEs are to comply with this provision is, for assets owned and/or operated by the RICE, the RICE should describe a standard operating procedure for equipment maintenance according to best practices. NOAA agrees that reviewing subcontractors' inventories and equipment history logs would be overly burdensome; yet, the rule does not dictate the required actions of the RICE, only that the RICE must have a standard operating procedure in place. For assets financially supported by the RICE, fully or partially, but operated by a subcontractor, the RICE should instruct subcontractors to follow best practices and should mandate that equipment maintenance reports should be available periodically or by request.

Comment 10: Section 997.23(d)(4)(i) requires more definition. Equipment should be specifically defined as capital equipment, e.g., exceeding $5000 in value with a shelf life of greater than three years. Also, Terms and Conditions to meet this requirement should be supplied by NOAA for inclusion in sub-awards from the RAs.

Response 10: NOAA agrees that § 997.23(d)(4)(i) requires clarification, and has amended the rule to include a definition for the term equipment, which includes a price floor of $5000. This amount is used to be consistent with OMB Circular No. A-122, establishing principles for determining costs of grants, contracts and other agreements with non-profit organizations. A-122 defines equipment as “nonexpendable, tangible personal property having a useful life of more than one year and an acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-profit organization for financial statement purposes, or $5000.” NOAA stresses that even though documented procedures are not required for certification for assets below the price floor, RICEs should maintain all equipment according to industry best practices.

NOAA disagrees that it should supply Terms and Conditions for this requirement. NOAA has taken a position, based on feedback from the RICEs during the development of the rule, that where possible, this rule shall avoid being too prescriptive, so as to allow each RICE to address the requirements as they see best, given their unique situation. NOAA believes that it is the responsibility of each RICE to work with their legal counsel and fiscal agents to develop contract language that meets their specific needs.

Comment 11: Section 997.23(f) of the Strategic Operational Plan (Data Management and Communication Plan) lists six actions. Shall these actions be implemented simultaneously, or can the regional or local entity prioritize? Data quality control procedures vary from entity to entity. It is going to take time and effort to bring everyone to the same level.

Response 11: All actions must be sufficiently addressed to achieve certification. The order by which the actions are addressed is at the discretion of the RICE.

Comment 12: The rules should state how the U.S. IOOS Program intends to handle model output, observational grids, or project level GIS data layers.

Response 12: Through this rule, NOAA is not providing guidance on model output or any other non-observational data in the certification requirements at this time. The IOOS Program Office welcomes a discussion with all IOOS partners to develop best practices related to these other types of information, but any proposed standards/processes would not be tied to certification.

Comment 13: Will a program that wants to contribute data to an IOOS-supported regional data portal be expected to adhere to an IOOS-sponsored or supported DMAC requirement for metadata (e.g., ISO 19115 and SensorML) and QA/QC (e.g., QARTOD)? The rule provides examples of qualified procedures (e.g., QARTOD, JCOMM/IODE, scientific literature), but we interpret these as examples and not mandates. If adherence to the specific standards mentioned is mandatory, this will discourage many programs from sharing data through IOOS.

Response 13: NOAA has clarified the guideline to address the commenters' concerns. For variables with documented QARTOD procedures, these procedures must be implemented and referenced on the RICE's Web site. For variables without documented QARTOD procedures, the quality control (QC) procedures are subject to the judgment of the RICE until QARTOD standards become available, but QC of some type must be performed and referenced. The RICE may choose to make data contributors responsible for QC and reference the procedures in the DMAC plan, or may perform the QC itself. Because the RICE can choose to perform QC of the data, we believe this requirement should not substantially deter other programs from sharing data through IOOS. Certification does not specifically mandate any DMAC requirements for metadata.

Comment 14: Greater flexibility is needed in the regulations to allow the wide spectrum of contributions to IOOS. The RICE should be allowed to provide data of various levels of quality to the system as long as the provenance of the data being discovered and exposed is made easily accessible through metadata that allows the user to assess the veracity and quality of the data.

Response 14: Since NOAA will provide the RICE with liability protection for activities related to its work on the dissemination and use of observation data, it is important that proper data management practices are in place and followed to mitigate the risk of liability. At a minimum, all data distributed by the RICE must be quality controlled either by the RICE or by the entity providing data to the RICE. This is the minimum step necessary to ensure data quality. While the RICE may include a description of the provenance of the data in the metadata, this does not replace the need to perform quality control on all data.

Comment 15: Documenting the quality control and assurance procedures for each individual data stream will be repetitive and time consuming. Rather, it would be more realistic to document the quality assurance protocols developed by individual data providers/sources. Overall, additional guidance detailing best practices and real world approaches to applying QC in an operational setting would be useful due to the large number of data streams that a RICE makes available.

Response 15: Since a data source can produce multiple data streams, and since each data stream must be quality controlled, the language was not changed. In practice, the RICE does not need to document the quality control procedures for each and every data stream. Data streams with similar QC procedures can be combined into larger categories, and the QC procedures for these larger categories can be described in the RICE's Data Management Plan as part of the certification application. The comment also asks for guidance on real world approaches to applying QC in an operational setting. The new rule language mandates QARTOD procedures for variables which QARTOD manuals are available. These manuals establish a framework that addresses real time collection and processing of these data through QC tests with codeable instructions. For variables which QARTOD manuals do not exist, quality control procedures are subject to the judgment of the RICE, providing flexibility to the RICE.

Comment 16: Federal agencies collecting ocean data that are distributed through RICE portals should have the QC responsibility for their own data streams. It would be helpful if the certification document clarified the nature of observing programs and networks that are the result of federal-regional partnerships, particularly CDIP and NERRS.

Response 16: NOAA does not expect that RICEs should perform their own QC on Federal data sources, but are encouraged to reference existing Federal QC procedures if the RICE makes these data available. For CDIP and NERRS, these programs are considered largely Federal and thus the RICE would not be required to perform QC on these data, if they are redistributing that data as is. In the case of CDIP, if a RICE deploys a wave buoy and provides that data independently on the RICE data portal, QC must be performed according to QARTOD standards, if available, or documented procedures if QARTOD manual is not available. For other federal-regional partnership programs that may exist currently or in the future, RICEs and the IOOS Program Office will assess on case by case basis.

Comment 17: Some Federal data sources serve RICE data, and it seems unreasonable for IOOS to require RICEs to document or enforce additional standards and protocols for data that is `qualified' to be presented via these other federal portals.

Response 17: Within NOAA, when a Federal center receives a RICE data source, the QC procedures of that center are required to ensure NOAA meets its own indemnification. For example, in the case of NDBC, mentioned in the comment, NDBC applies QC procedures before making the data public, so in effect, the RICE data is not “qualified as is” to be disseminated via NDBC. Further, the data that NDBC rebroadcasts is only a subset of the total RICE data. Finally the process is that the RICE data is simultaneously disseminated to NDBC and the RICE data portal. The RICE does not wait until NDBC has performed the QC to disseminate their data. Therefore, NOAA maintains for the purpose of certification, the RICE must separately perform quality control on the data.

Comment 18: We request that the US IOOS Program Office host discussion sessions with the IOOS community about the IOOS standards for metadata and quality assurance and how all the individual parts fit together.

Response 18: NOAA agrees discussion sessions would be beneficial. The IOOS Program Office hosted annually since 2008 a collaborative working session with the Regional Association Data Managers where quality control and metadata standards have been discussed. Specifically at the Data Management and Communications Meeting in September, 2013 in Silver Spring a session was dedicated to the implementation of IOOS certification requirements and data management requirements from NOAA. For the last three years, at both the Spring and Fall IOOS association meetings, data management has been on the agenda. These topics have been discussed at a number of IOOS Regional Association meetings and it is almost always requested and discussed at the individual regional meetings. The IOOS Program Office will continue to participate/host additional discussion sessions.

Comment 19: The RICE cannot exert much control over partners with little or no financial support from IOOS. The inclusion of a limited set of metadata and QA/QC flags transmitted to the RICE is not unreasonable from non-IOOS funded data streams. However, data generated with IOOS funding would be a different matter as the RICE would have more control over those operations and data processing steps. RAs should have the option of serving data from non-federal providers who don't receive financial support from the RAs without going through the same level of QC and oversight that they provide for organizations they do support. A suggestion would be to have different categories of data streams on the portal: Federal, RA-supported, and other. Data streams would be clearly identified as to their source and which category they fell in, and metadata would be provided to allow users to decide which data streams were adequate for their use.

Response 19: NOAA disagrees that the RICE should have the option of serving data from non-federal providers who don't receive financial support from them without going through the same level of QC and oversight that they provide for organizations they do support. QC must be performed on all data that the RICE makes available, regardless of funding source. The quality control requirements are not overly burdensome since the rule does not require that the RICE partners perform their own QC. Rather, the RICE is responsible for QC and may assign the responsibility to its partners or may choose to perform the QC itself. NOAA does not agree with the idea of developing data categories based on financial contribution from the RICE. The premise of IOOS is to leverage capabilities from a variety of Federal, non-Federal, academic, industry, etc. sources in order to increase the availability and use of coastal and ocean information. Data categories based on funding would result in confusion and would oppose the concept of open data sharing through the RICE.

Comment 20: It is not clear why the “RICE's plans and strategies for diversifying funding sources and opportunities;” is relevant to integration into the national program. This should not be part of a federal certification process.

Response 20: NOAA agrees that the requirement is not relevant to integration into the national program, and has removed this requirement from the rule.

Comment 21: Certification should not establish new unfunded mandates. The current certification process establishes the need for an online “Regional Asset Inventory” that has previously not been required.

Response 21: The rule sets minimum requirements for certification based on the ICOOS Act language and the IOOC approved certification criteria. NOAA does not agree that the rule establishes unfunded mandates, as the pursuit of certification is voluntary. Regarding the Gaps Identification requirement referenced in the comment, the rule does require the establishment of a regional asset inventory, but states that a “database or portal accessible for public viewing” could demonstrate that a RICE meets this requirement.

Comment 22: Requiring the RICE's subcontractors document operating and maintenance costs for their observing platforms that contribute data even when IOOS funds may not contribute to that operation or maintenance may discourage participation in the system. Certification should be a five year process with no pieces in between. Operating costs should not be required annually.

Response 22: A RICE is only required to document its annual operating and maintenance costs for assets owned and/or operated by the RICE as defined. The annual financial information is intended to report on expenditures by the RICE. For example, in a RICE to subcontractor relationship, only the RICE funds to the sub-contractor would be included in the reports. Funds the sub-contractor receives from other entities would not be included in the report by the RICE. The annual budgets submitted by the RICE, as part of a cooperative agreement, will meet this requirement.

With respect to the commenter's concern that certification “should be a five year process with no pieces in between,” NOAA revised § 997.25 (c) to clarify that the RICE need only submit the annual operating and maintenance costs upon request. While NOAA understands the desire to have manageable tasks associated with certification, it believes that although a RICE is certified, there should be measures in place to ensure accountability. The Act requires a RICE to “comply with all financial oversight requirements established by the Administrator, including requirements relating to audits.” NOAA must be able to have a process, in addition to audits, to ensure fiscal oversight. Requiring the RICE to annually document its operations and maintenance costs, and providing those upon request, is one way to achieve this.

Comment 23: One of the main incentives for a Regional Association (RA) to apply for certification is for liability protection. The extension of liability protection to no more than three individuals doesn't seem to fulfill the sense of the ICOOS Act. It is not clear why limiting indemnification is relevant or necessary. The limitation of protection to three individuals should be removed so as to allow the RA to submit the names of all individuals responsible for operations, including Board members and contractors, to NOAA for review and approval. Civil liability should not be limited when all affiliates are potentially at risk for legal action as well. This will lead to challenges recruiting Board members and the kind of staff members necessary to continue to develop the U.S. IOOS system at the regional level. Additional language is needed to explain the meaning and extent of “The individual is responsive to federal government control.”

Response 23: NOAA agrees there may be more than three individuals who are responsible for RICE operations. NOAA has revised the rule, allowing a RICE to identify more than one individual responsible for each of these areas: Overall system management; observations system management across the region; and, management of data operations across the region. In order to be approved for certification, a RICE must demonstrate that these individuals are responsible for managing operations across the region, and are responsive to federal control.

The ICOOS Act associates civil liability to employees. While the ICOOS Act does not clearly define employee, causing some ambiguity about who qualifies for the extension of civil liability, the term employee does have specific meaning in Federal tort law. According to the Federal Tort Claims Act, and for the purposes of this rule, an employee of the government includes, “persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation.” Given this definition, to be considered a RICE employee under this rule, an individual must be formally acknowledged by NOAA and that individual shall be responsive and accountable to NOAA.

In response to the comment suggesting that NOAA further explain the “meaning and extent of `The individual is responsive to federal government control,' ” NOAA has chosen to leave the language of this rule unchanged in order to retain flexibility in working with each RICE. This approach is necessary due to the variations in RICE organizational structures and the mechanisms available to NOAA to ensure RICE employee responsiveness. Since RICEs by their nature operate through the extensive use of partnerships and non-traditional employee/employer relationships, this creates challenges in applying the definition of employee from Federal tort law.

NOAA has identified in the rule, those positions that most closely meet the intent of the meaning of employee from Federal tort law. The positions identified in the rule have significant impact on, and are influential in, assuring the reliability of the data. As such they are in positions to mitigate the risk of liability arising from the dissemination and use of observation data. These positions work across the region and are accountable to the RICE and NOAA for data collection, dissemination, and use.

Comment 24: It is recommend that NOAA and the IOOS Program Office work with the regional associations to undertake a full review of the options available to limit the RICE's liability risk.

Response 24: NOAA is available to discuss the rule and how it will be implemented. NOAA understands the commenter's concern about a RICE's liability risk, but each RICE should seek its own legal advice.

Comment 25: Please clarify—do data providers or regional partners to GCOOS have to have individual contracts, leases, grants, or cooperative agreements with NOAA to be protected, or can their membership in GCOOS qualify them as protected from civil liability? We strongly encourage the latter to minimize costs and facilitate participation in the RICE and IOOS.

Response 25: While NOAA appreciates the RICE's concern about the liability status of their partners, certification is for the RICE alone and the extension of civil liability protection is to certified RICEs and their employees only. Under the rule, employees of a RICE are defined as those individuals filling the positions identified in the rule and are the only individuals covered by the civil liability protection. Neither membership in a RICE or a contract, lease, grant, or cooperative agreement with NOAA is sufficient to qualify an entity, organization, or individual as protected from civil liability.

Comment 26: The benefits of certification are not clear. One is the extension of federal tort liability protection to two or three employees of a certified RICE. I say two or three because it is not clear that three are actually covered. § 997.30(c)(2) states that the individuals to be protected must be identified under § 997.23(d)(3), which only lists two positions.

Response 26: NOAA agrees that paragraph (c)(2) of the civil liability section is not clear and revised the section to account for all the individuals that may fill the three positions identified in § 997.23(d)(3) and § 997.23(f)(1)(i) and to be consistent with the definition of Employee of a Regional Information Coordination Entity in the rule.

Comment 27: The primary responsibility of an employee and/or Board of Directors is to the corporation. As such, conceding power to another organization (NOAA) in oversight of RICE employees and/or contractors as required in the regulations (§ 997.30) has the potential for conflict of interest and is unacceptable. Compliance with program requirements is already legally covered through the Cooperative Agreements.

Response 27: In order for the federal government to afford civil liability to an employee, there must be a relationship between the federal government and the employee characterized by responsiveness and accountability. Certification requirements are separate and distinct from the cooperative agreements, which are awarded through a competitive process. A funding agreement with NOAA is not a requirement for certification. Having a stand-alone certification process ensures that NOAA has a mechanism for working with certified RICEs.

Comment 28: Shall a non-federal employee who is participating in the System, being paid one month salary by contract (ICOOS, etc.) and eleven month by his or her local entity, be considered, with respect to tort liability, an employee of the Federal Government?

Response 28: The extension of civil liability protection is to employees of certified RICEs only as defined in the rule.

Comment 29: If the local entity has a “Disclaimer” on its own Web site for data users that it does not accept liability for any damages or misrepresentation caused by inaccuracies in the data or as a result of changes to the data caused by system transfers, transformations, or conversions, nor is there responsibility assumed to maintain the data in any manner or form, will this Disclaimer contradict with the IOOS tort liability/civil liability?

Response 29: The grant of civil liability protection applies only to a certified RICE and its employees identified in § 997.26(c)(2). A disclaimer would not affect this status.

Comment 30: Switching the focus of certification to those activities that are 100% funded by IOOS could help simplify the limitation of what is covered under indemnification, without also limiting the number of potential individuals that could be impacted by legal action.

Response 30: The extension of liability coverage is to the RICE and its employees as defined in the rule, and is independent of funding amounts or sources that support the dissemination and use of observation data. The certification process is separate from the competitive grants process that NOAA uses to fund the development of regional observing systems and the regional entities that coordinate this development.

Comment 31: The draft rules define “owned and/or operated” as an asset that is supported financially in part or full by the RICE. This implies that we would be required to meet these standards even, if we are providing only a small portion of the operational costs for an asset. We recommend that this section be reworded to be less stringent and that the definition of “owned and/or operated” be changed to an asset that is supported financially in full by the RICE.

Response 31: This rule clearly defines “owned and/or operated” as including any asset that is supported financially in part or in full by the RICE, regardless of the amount of this support. To be certified, a RICE must meet the standards for all assets that fall within this “owned and/or operated” definition, even if the RICE provides relatively little funding to support those assets. NOAA stands by this definition and disagrees with the comment suggestion that this definition “be changed to an asset that is supported financially in full by the RICE.” In order to certify a RICE and extend liability protection under the Act, NOAA must ensure that all data distributed by that RICE, regardless of funding source or amount, meets quality assurance standards.

Comment 32: The description also fails to state that there will be one RICE per region. NOAA should clarify the language to state that, “Existing Regional Associations in IOOS will be prioritized for the designation as the single RICE for IOOS in the region.”

Response 32: NOAA cannot accept the suggested text because it is inconsistent with the Act and would give preferential treatment to some applicants over others. The Act defines RICEs as including Regional Associations, but does not limit RICEs to only these entities. Further, the Act makes no mention of limiting the number of RICEs by geography or any other criteria. NOAA must review all applications it receives and objectively evaluate them against this rule's requirements.

NOAA is committed to having regional entities that cover the entire U.S. ocean and Great Lakes coasts. These regional entities are an important component of the overall IOOS system. NOAA has worked closely with the eleven regional associations that belong to the IOOS Association to develop the organizational and observing system capacity to serve in the role of a RICE, and expects that these entities will be well suited to become certified RICEs should they choose to apply. However, NOAA is required to consider all the applications that it receives for certification as a RICE.

Comment 33: Provide guidance on what happens if an RA chooses not to be certified or becomes decertified. Would they still be “integrated into the System”? If a RICE is decertified, will they risk losing funding or other benefits?

Response 33: Certification is the formal process for incorporating a RICE into the System. A regional association that chooses to not pursue certification will not be formally incorporated into the System. If a RICE is decertified, that entity will no longer be incorporated into the System and will not receive the benefits of being a certified RICE. The certification process is separate from the competitive grants process that NOAA uses to fund the development of regional observing systems and the regional entities that coordinate this development. It is not the intent of NOAA to tie certification to the competitive funding program.

Comment 34: Section 997.13(c) requires written notification from the RICE to NOAA and approval by NOAA of any changes to the “details originally provided” for the Strategic Operational Plan (SOP). This language is too prescriptive and burdensome. An annual statement could be filed outlining any substantive changes at an RA. Change 997.13(c) to read: A certified RICE shall provide NOAA with written notification of the RICE's intention to substantively change its organizational structure or SOP.

Response 34: NOAA concurs that the original language is too prescriptive and has revised § 997.13(c) to now require a RICE to notify NOAA only when substantive changes are made to its organizational structure or Strategic Operational Plan, rather than when any changes to the details of the structure or Plan as published the proposed rule.

Comment 35: I recommend that the RICEs be given 45 days, not 30, to request in writing a reconsideration of NOAA's decision to decertify or to notify NOAA of corrective action.

Response 35: NOAA concurs and, based on this public comment, has revised § 997.15(c) to now state that RICEs have 45 days to request reconsideration of NOAA decision.

Comment 36: The rule should be amended to require that NOAA inform RICEs of the audit procedure that will be used, and also to provide adequate notice of its intent to audit. Under what conditions may NOAA audit a RICE? Will “just cause” be required to audit a RICE or can it be done randomly?

Response 36: NOAA concurs that a RICE be given notice of an audit and that NOAA will coordinate with the RICE on the timing and process for the audit. Section 997.15(a) has been revised to reflect this policy. NOAA reserves the right to conduct audits as needed to ensure the integrity of the certification process and will work with the RICEs to mitigate potential impacts of the audit.

Comment 37: The rules should acknowledge that compliance will depend on available resources. Each year, the IOOS Program Office works with individual RAs on descoping the annual budgets. This process should be used to fulfill this requirement. Approval by the U.S. IOOS Program Office of the annual spending plans through the descoping process should account for compliance with these regulations.

Response 37: Each organization must decide whether they are going to pursue and maintain certification based on their available resources. Certification is not dependent on any funding amount or agency funding opportunity, and as such, compliance with the certification requirements cannot be re-evaluated year to year based on funding levels. NOAA agrees that existing documents can serve the purpose of showing compliance with the certification requirements and has indicated this in section 997.20(b).

Comment 38: Complying with this requirement would be a major new burden on our limited resources. NOAA is underestimating the time, effort, and expense that it will take to come into full compliance with the proposed regulations. The time anticipated to complete the application packet should be no more than one week (40 hours). We estimate it would take roughly 2-2.5 person-months effort for the initial submittal, ~1.5-2 person months every 5 years for recertification as requirement change, ~1 person month each year for annual compliance, and an unknown amount of time to comply with audit requirements. Any cooperative agreement with NOAA should be adjusted to reflect these real costs.

Response 38: The estimate of two or two and one half person months (320-400 hours) effort for the initial submittal is not far from the 293 hour estimate put forth in the proposed rule, and was done without the benefit of the rule implementation guidance that NOAA is developing. NOAA points out that this effort is only required every five years. We disagree with the estimate that annual compliance will require 160 hours of effort, and NOAA is committed to working with a RICE to mitigate the cost of any audit.

When estimating the amount of effort to submit an application, NOAA must include not just the time necessary to fill out the form and submit the application, but also the time estimated to meet the requirements for certification. This amount will vary depending on the relative maturity of the applicant organization.

Since no justification is given for the statement that the application packet should be no more than 40 hours, we can't respond to its viability.

NOAA disagrees with the comment that it should adjust its existing cooperative agreements with the entities that are interested in pursuing certification. Any applicant with a financial agreement with NOAA can direct their resources towards becoming certified. Through a series of cooperative agreements, NOAA has funded the eleven Regional Associations since FY 2005 to develop the organizational structure, operating procedures, and data management capacity necessary to serve in the role of RICEs. Certification is optional, and a Regional Association opting to pursue certification can re-prioritize existing resources to do so, since much of the effort, particularly the data management work, is consistent with their overall work plans established for these agreements. Finally, since application for certification is not mandatory, each organization can determine if the benefits of being certified is worth the cost.

Comment 39: This section should enumerate all potential benefits for a RICE for becoming certified.

Response 39: The potential benefits of a RICE becoming certified are identified in the “Background” and “Classification” sections in this rule.

Comment 40: The rule should clearly state that RICEs not seeking certification will not lose their future eligibility for funding, or the amount of funding they receive as a regional association within U.S. IOOS, or other penalties.

Response 40: U.S. IOOS will have regional entities that cover the entirety of the U.S. ocean, coast, and Great Lakes. These regional entities are an important component of the overall U.S. IOOS system. The certification process is separate from the competitive grants process that NOAA uses to fund the development of regional observing systems and the regional entities that coordinate this development. The establishment of a certification process is a requirement of the ICOOS Act and creates the formal process for incorporating a RICE into the System. It is not the intent of NOAA to tie certification to the competitive funding program, nor is it NOAA's intent to favor one regional entity over another based on certification decisions.

Comment 41: In general it is unclear what level of detail is required to satisfy the certification criteria. Detailed and reviewed examples of what would pass the process would be very useful. With an inevitable turn-over of personnel at both the US IOOS program office and in the regions, it is important the certification rules be as clear as possible about the requirements.

Response 41: NOAA will publish certification guidance online at http://www.ioos.noaa.gov/certification within 30 days of publishing the final rule in the Federal Register .

Comment 42: Certification requirements should be in proportion to the scale of the existing programs. For example, current funding levels do not allow for the clearest organizational design and while RAs may desire to have an observing system manager current funding levels may not allow such a position to exist.

Response 42; This final rule sets minimum requirements for certification based on the ICOOS Act language and the IOOC approved certification criteria. NOAA understands that regional entities are unique and has avoided being prescriptive in the requirements when possible.

Comment 43: We recommend that you keep implementation requirements as simple as possible, and tie them to the existing 5-year cooperative agreement proposals and annual descoped proposals. Execution of the cooperative agreement, also having a life-span of five years, would therefore serve as certification and meet the requirements of the ICOOS Act.

Response 43: The certification process is separate from the competitive grants process that NOAA uses to fund the development of regional observing systems and the regional entities that coordinate this development. The establishment of a certification process is a requirement of the ICOOS Act and creates the formal process for incorporating a RICE into the System. It is an agreement between NOAA, as the lead agency for the System, and the RICE. The cooperative agreements that fund the development of regional IOOS are an agreement between the IOOS Program under NOAA and the regional associations that have been awarded funding through the competitive funding opportunity offered by NOAA. NOAA agrees that existing documents can serve the purpose of showing compliance with the certification requirements and has indicated this in the rule.

Comment 44: The criteria should facilitate the use of ocean acidification research and monitoring for implementation of the Clean Water Act. RICEs should be informed of Clean Water Act water quality criteria and be required to provide their monitoring data and other relevant information to EPA, tribes, and states for use during their water quality assessments. Data quality protocols should be preapproved by EPA, tribes, and coastal states so that ocean acidification data can automatically be used for water quality assessments.

Response 44: The U.S. IOOS supports the free and easy access to data by all stakeholders interested in ocean acidification. Many of the regional associations and their partners are actively collecting and distributing ocean acidification data. These organizations are working closely with federal and non-federal partners on data collection and data management processes.

Comment 45: State and industry monitoring programs under the Clean Water Act should be adapted to collect data relevant for ocean acidification.

Response 45: This recommendation is outside the scope of the ICOOS Act and the certification of RICEs.

Comment 46: As written the regulations impose burdens that are likely to prevent many non-federal data providers from contributing their important assets to the IOOS System. I request that NOAA review the regulations and where possible within the mandate of the law to simplify them and narrow their scope so as to encourage participation in the building of the IOOS rather than discourage it.

Response 46: The rule sets minimum requirements for certification based on the ICOOS Act language and the IOOC approved certification criteria. It is not NOAA's intent to create disincentives to participation in the U.S. IOOS, but to establish formally, the organizational qualities of a RICE and ensure a level of data collection, management, and distribution practices are in place. NOAA followed the notice and comment requirements set forth in the Administrative Procedure Act in the development of this action. NOAA has revised the rule based on the comments it received where possible, with the intent of improving the rule.

Comment 47: While many of the criteria related to governance might be good suggestions for organizational operations, they do not directly influence or improve the ability of a RICE to be “integrated into the System,” particularly in the context necessary to support indemnification for the collection, dissemination, and use of observation data.

Response 47: The requirements in this final rule are responsive to the language in the ICOOS Act and the IOOC approved Certification Criteria. Section 12304(c)(4)(A) of the ICOOS Act identifies the requirements a RICE shall meet, including those related to an organizational structure. These are further developed in the IOOC Certification Criteria and form the basis for the requirements contained in this rule.

Comment 48: This rule does not reflect the range of efforts that comprise IOOS including the concept of a spectrum of research and operations that was embraced and the 2012 IOOS Summit. Not all aspects of RA systems are operational (§ 997.23(f)(4)). DMAC processes should include those for modeling which is not mentioned in the certification requirements.

Response 48: NOAA disagrees that this rule does not reflect the range of efforts that comprise IOOS. The rule makes several references to the different components that make up the System, such as in § 997.21(a) and § 997.23(c)(2). This rule sets minimum requirements for certification based on the ICOOS Act language, which includes references to the System Plan, and the IOOC approved certification criteria. While a new concept of a spectrum of research and operations was put forth at the 2012 IOOS Summit, this concept has yet to be formally recognized in the way the System Plan has.

The focus is on creating a process to certify a RICE and incorporate it into the System. NOAA acknowledges that the requirements are not inclusive of all the activities that a RICE might engage in, such as modeling. As mentioned in Response 12, NOAA is not providing guidance on model output or any other non-observational data in the certification requirements at this time. Since the extension of liability protection covers observational data, the DMAC requirements are limited to observational data. NOAA will consider including requirements for activities like modeling in the future.

Comment 49: Certification should respect the operational integrity and independence of the RAs. One of the strengths of the RAs and benefits for NOAA is their ability to act nimbly and be responsive. The current regulations would curtail that ability.

Response 49: NOAA disagrees that this rule would curtail the ability of an RA to act nimbly and be responsive to regional issues and stakeholder needs. Since the comment provides no specifics on how the regulations would curtail the ability of the RAs to continue to act nimbly and be responsive to new priorities and needs, we cannot respond more substantially to it. NOAA has revised § 997.13(c) to now require a RICE to notify NOAA only when substantive changes are made to its organizational structure or Strategic Operational Plan, rather than when any changes to the details of the structure or Plan as published the proposed rule. NOAA must have in place a process to ensure accountability, but it does not intend to be involved in the day to day operations of the RICE.

Comment 50: We fear that the application of these rules, particularly on the data management and QA/QC process, may discourage data sharing, thereby setting back many of the gains made by the program to date and being counterproductive to the IOOS goal of increasing stakeholder access to data and fostering data discovery.

Response 50: NOAA has addressed some of the concerns received in the comments about the rule's data management requirements being onerous and discouraging data sharing by clarifying the rule requirements. The RICE may choose to make data contributors responsible for QC, or may perform the QC itself. Because the RICE can choose to perform QC of the data, we believe this requirement should not substantially deter other programs from sharing data through IOOS. Instead of being counterproductive to the U.S. IOOS goals and objectives, NOAA thinks the requirements for data quality assurance and quality control procedures strengthen the U.S. IOOS by ensuring data management practices are in place for all data that are distributed through the System.

Comment 51: We request that the US IOOS Program Office host discussion sessions with the IOOS community about the IOOS standards for metadata and quality assurance and how all the individual parts fit together.

Response 51: NOAA is happy to work with the IOOS community to discuss how standards for metadata and quality assurance, along with other data management processes fit together. The IOOS Program has regular discussions with the regional data management community and continues to sponsor the QARTOD effort.

Under Executive Order (E.O.) 12866, if the proposed regulations are a “significant regulatory action” as defined in § 3(f) of the Order, an assessment of the potential costs and benefits of the regulatory action must be prepared and submitted to the Office of Management and Budget (OMB). OMB has determined that this action is not a “significant” regulatory action under E.O. 12866.

Pursuant to section 605 of the Regulatory Flexibility Act (RFA), at the proposed stage, the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities.

During the public comment period for the proposed rule, NOAA received several comments from the IOOS Regional Associations regarding the economic impact of pursuing certification; NOAA did not receive any comment from the Small Business Administration (SBA) on the matter.

The comments NOAA received on the certification included that:

• NOAA is underestimating the time, effort, and expense that it will take to come into full compliance with the proposed regulations and would be a major new burden on the limited resources of the RICE.

• The assumption that the information needed to document compliance with the regulations is already generally available is incorrect. Several of the documents that are requested will need to be assembled and formatted from existing documents.

• The rule might have the unintended consequence of reducing the amount of non-federal data now being made available through the RICE's regional portals. NOAA responds to the comments as follows:

The Integrated Coastal and Ocean Observation System Act of 2009 (ICOOS Act or Act) directs NOAA to “promulgate program guidelines to certify and integrate non-Federal assets, including regional information coordination entities into the System.” This rule establishes the criteria and procedures for certifying and integrating RICEs into the Integrated Coastal and Ocean Observation System (System), in compliance with the ICOOS Act.

Specifically, the rule requires RICEs to provide NOAA with certain information about their organizational structures, financial capabilities and makeup, oversight, and data quality assurance methods in order to obtain certification under the ICOOS Act. In return for providing NOAA with data of known quality via replicable means and with oversight, NOAA will provide the RICEs with liability protection for activities related to their work on the dissemination and use of observation data. Integration into the System formally establishes the role of the RICE and ensures that the data collected and distributed by the RICE are managed according to the best practices, as identified by NOAA.

Currently, there are eleven RICEs that NOAA expects may be impacted by these regulations, corresponding to those entities that currently coordinate the regional ocean and coastal observing system efforts of the U.S IOOS. RICEs are generally partnerships of entities in the academic, private, governmental, tribal, and non-governmental sectors. Five of the RICEs are organized as not-for-profit organizations under § 501(c)(3) of the Internal Revenue Code; the other six are organized pursuant to Memorandums of Agreement between the constituent members. Most of these eleven RICEs employ from three to five full or part-time individuals, either directly or as contractors. Some or all of these RICEs may be considered “small organizations” under the RFA, although that status is unclear. 5 U.S.C. 601(4).

Regardless of organizing instrument, RICEs primarily depend on funds from NOAA for their operations. Through a series of cooperative agreements, NOAA has been funding these eleven RICEs since FY 2005 to develop the organizational structure, operating procedures, and data management capacity necessary to serve as the entities responsible for planning, coordinating, and operating the regional observing systems. Funding levels to build the organization and coordination capacity of these eleven RICEs, made available through these cooperative agreements, varies by region, but has typically ranged from $300K to $400K per year per RICE. In addition, beginning in FY 2008, each of these eleven RICEs entered into cooperative agreements with NOAA to support data collection, data management, and development of products and services. In FY 2012, the funding amounts for these eleven RICEs ranged from $1.4 million to $2.5 million per RICE.

This rule establishes generally applicable criteria for data collection and quality that all RICEs must meet, in order to be incorporated into the System and to obtain the liability protection under the Act. In the proposed rule, NOAA set out the expected time of 293 hours that RICEs may need to comply with these rules and submit their applications for incorporation. The additional documentation requirements will help ensure that all RICE data meets the same minimum standard of quality, and it will help NOAA verify compliance with this rule's requirements. NOAA acknowledges that undertaking these efforts may result in some significant time outlays by RICEs, in particular because it may require them to create new procedures to document data management practices. However, NOAA does not expect the RICEs will incur significant costs, but would instead re-prioritize existing resources, as a result of this rule, because these efforts will not affect their current funding agreements with NOAA, and much of the work, particularly the data management work, is consistent with their overall work plans established for these agreements.

NOAA will allow RICE's to use other documents they may already possess to demonstrate they meet certification requirements. Thus, NOAA does not expect the other costs associated with organizing and submitting the information required for certification to NOAA will be significant because in the case of the regional associations, this information is similar to what has been developed as part of their NOAA funded work.

Additionally, most RICEs have some data management and quality control procedures in place. NOAA acknowledges that satisfying the certification requirements may result in a RICE having to re-allocate existing funds to implement new data management practices, and to document that required data management practices are in place. NOAA based its hourly burden estimate on the time it would take a RICE, of average maturity, to meet the standards, but expects that some RICEs will expend less time and fewer resources to meet the new requirements. However, since the RICEs have different levels of data management maturity and have applied varied amounts of staff and financial resources towards data management, NOAA cannot determine the exact costs this rule may impose on any given RICE.

Finally, NOAA notes that this rule does not require RICEs to incur these expenses or time to become certified. RICEs may still apply for grants from NOAA, even if they are not certified. Indeed, NOAA expects those RICEs currently receiving NOAA funds under the ICOOS Act to seek certification, but again, lack of certification does not preclude funding opportunities. NOAA does not intend to create disincentives to participate in the U.S. IOOS, but rather to formally establish the organizational qualities of a RICE to ensure a high uniform level of data collection, management, and distribution practices, which NOAA will certify. Therefore, if a RICE wants to be incorporated into the System, and receive the liability protection from NOAA the Act authorizes, then they will need to be certified which includes ensuring their data collection and management practices meet the standards set out in this rule.

Because this rule does not require RICEs to incur any costs to continue operating, but only if they seek certification and the benefits of liability protection under the ICOOS Act, and because the costs to RICEs that seek certification will vary, NOAA maintains that this rule will not have a significant economic impact on a substantial number of small entities. Therefore, no Regulatory Flexibility Analysis is required, and none has been prepared.

Nonetheless, in response to the comments to the certification under the RFA that NOAA received during the comment period to the propose rule, NOAA has made the following changes to this final rule:

• Revised § 997.15(a) to state that a RICE be given notice of an audit and that the NOAA will coordinate with the RICE on the timing and process for the audit.

• Revised § 997.13(c) to require a RICE only seek approval from NOAA for substantive changes to its organizational structure or Strategic Operational Plan.

• Revised § 997.15(c) to allow a RICE 45 days to request in writing a reconsideration of NOAA's decision to decertify or to notify NOAA of corrective action.

• Revised § 997.23(d)(4)(i) to bound the extent of the requirement to a tangible asset that is functionally complete for its intended purpose and has a capital cost of over $5000. Revised § 997.23(f)(3) to state that the RICE is not responsible for performing quality control on data it makes available that is accessed from a federal data source.

• Deleted the requirement (proposed as § 997.23(g)(2)) that a RICE describe it plans for diversifying funding sources.

This rule contains collection-of information requirements subject to the Paperwork Reduction Act (PRA), which OMB has approved under control number 0648-0672.

It is expected that there will be a total of eleven applicants, corresponding to those entities that currently coordinate the regional ocean and coastal observing system efforts of U.S. IOOS, that will pursue certification as a RICE. The response time for each applicant is estimated to be 290 hours. The burden of effort associated with the collection of information is needed to demonstrate that the necessary policies, standards, data, information, and services to function in the role of a RICE are appropriately established, coordinated, overseen and enforced.

During the public comment period for the proposed rule, NOAA received several comments regarding the estimated amount of effort necessary to develop and submit the information requested to document compliance with the certification requirements. In summary, these comments expressed that NOAA underestimates the time, effort, and expense that it will take to come into full compliance with the proposed regulations and would be a new burden on the limited resources of the RICE. These comments, and NOAA's response, are addressed in the “Response to Comments” section above.

NOAA did not receive any public comments on the application form; however the form was revised to incorporate the changes to the rule requirements. NOAA does not expect that these changes will result in any additional burden on applicants.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

Table of Contents Executive Summary I. Background: FDASIA Requirements II. Proposed Rule and Final Rule A. Finalization of Factors Considered and Methodology Used for Establishing a List of Qualifying Pathogens B. Finalization of Statutory Interpretation C. Finalization of Proposed Pathogens for Inclusion on the List D. Summary of Additional Pathogens on the List of Qualifying Pathogens III. Comments to the Proposed Rule and FDA's Responses A. Statutory Interpretation and Proposed Factors for Consideration B. Miscellaneous Comments C. Comments on Previously Proposed Pathogens D. Suggestions for Additional Qualifying Pathogens IV. Environmental Impact V. Analysis of Economic Impact A. Final Regulatory Impact Analysis B. Background C. Need for and Potential Effect of the Regulation VI. Paperwork Reduction Act VII. Federalism VIII. References Executive Summary Purpose of the Regulatory Action

Title VIII of FDASIA (Pub. L. 112-144), the GAIN title, is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections. Among other things, GAIN requires that the Secretary of the Department of Health and Human Services (and thus FDA, by delegation): (1) Establish and maintain a list of “qualifying pathogens” that have “the potential to pose a serious threat to public health” and (2) make public the methodology for developing the list (see section 505E(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by FDASIA) (21 U.S.C. 355f(f)). In establishing and maintaining the list of “qualifying pathogens,” FDA must consider the following factors: The impact on the public health due to drug-resistant organisms in humans; the rate of growth of drug-resistant organisms in humans; the increase in resistance rates in humans; and the morbidity and mortality in humans (see section 505E(f)(2)(B)(i) of the FD&C Act). FDA also is required to consult with infectious disease and antibiotic resistance experts, including those in the medical and clinical research communities, along with the Centers for Disease Control and Prevention (CDC) (see section 505E(f)(2)(B)(ii) of the FD&C Act). FDA issued a proposed rule on June 12, 2013 (78 FR 35155), and, after analyzing comments to that proposed rule, is issuing this final rule in fulfillment of the statutory requirements described above.

After holding a public meeting and consulting with CDC and the National Institutes of Health (NIH), and considering the factors specified in section 505E(f)(2)(B)(i) of the FD&C Act, FDA proposed on June 12, 2013, that the following pathogens comprise the list of “qualifying pathogens:” Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Enterobacteriaceae (e.g., Klebsiella pneumoniae ), Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors FDA considered and the methodology FDA used to develop this list of qualifying pathogens. After analyzing comments to the proposed rule, FDA has decided to retain the previously proposed methodology for developing the list of qualifying pathogens and will include the pathogens identified in the proposed rule on the list of qualifying pathogens. FDA also has applied the methodology set forth in the proposed rule to additional pathogens suggested by comments to the proposed rule. Based on these analyses, FDA also will add Coccidioides species, Cryptococcus species, and Helicobacter pylori to the list of qualifying pathogens. The table below describes the pathogen lists for the proposed and final rule for comparison:

The Agency has determined that this rule is not a significant regulatory action as defined by Executive Order 12866.

Title VIII of FDASIA (Pub. L. 112-144), entitled Generating Antibiotic Incentives Now, amended the FD&C Act to add section 505E, among other things. This new section of the FD&C Act is intended to encourage development of treatments for serious or life-threatening infections caused by bacteria or fungi. For certain drugs that are designated as “qualified infectious disease products” (QIDPs) under new section 505E(d) of the FD&C Act, new section 505E(a) provides an additional 5 years of exclusivity to be added to the exclusivity periods provided by sections 505(c)(3)(E)(ii) to (c)(3)(E)(iv) (21 U.S.C. 355(c)(3)(E)(ii) to (c)(3)(E)(iv)), 505(j)(5)(F)(ii) to (j)(5)(F)(iv) (21 U.S.C. 355(j)(5)(F)(ii) to (j)(5)(F)(iv)), and 527 (21 U.S.C. 360cc) of the FD&C Act. In addition, an application for a drug designated as a QIDP is eligible for priority review and designation as a fast track product (sections 524A and 506(a)(1) of the FD&C Act (21 U.S.C. 356n-I and 556(a)(1)), respectively).

The term “qualified infectious disease product” or “QIDP” refers to an antibacterial or antifungal human drug that is intended to treat serious or life-threatening infections (section 505E(g) of the FD&C Act). The term includes treatments for diseases caused by antibacterial- or antifungal-resistant pathogens (including new or emerging pathogens), or diseases caused by “qualifying pathogens.”

The GAIN title of FDASIA requires that the Secretary of the Department of Health and Human Services (and thus FDA, by delegation) establish and maintain a list of such “qualifying pathogens,” and make public the methodology for the developing the list. According to the statute, “the term `qualifying pathogen' means a pathogen identified and listed by the Secretary . . . that has the potential to pose a serious threat to public health, such as[:] (A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant [E]nterococcus; (B) multi-drug resistant gram[-]negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species; (C) multi-drug resistant tuberculosis; and (D) Clostridium difficile” (section 505E(f)(1) of the FD&C Act). FDA is required under the law to consider four factors in establishing and maintaining the list of qualifying pathogens:

• The impact on the public health due to drug-resistant organisms in humans;

• the rate of growth of drug-resistant organisms in humans;

• the increase in resistance rates in humans; and

• the morbidity and mortality in humans (section 505E(f)(2)(B)(i) of the FD&C Act).

Further, in determining which pathogens should be listed, GAIN requires FDA to consult with infectious disease and antibiotic resistance experts, including those in the medical and clinical research communities, along with the CDC, in determining which pathogens should be included on the list of “qualifying pathogens” (section 505E(f)(2)(B)(ii) of the FD&C Act). To fulfill this statutory obligation, on December 18, 2012, FDA convened a public hearing, at which the Agency solicited input regarding the following topics: (1) How FDA should interpret and apply the four factors FDASIA requires FDA to “consider” in establishing and maintaining the list of qualifying pathogens; (2) whether there are any other factors FDA should consider when establishing and maintaining the list of qualifying pathogens; and (3) which specific pathogens FDA should list as qualifying pathogens (77 FR 68789, November 16, 2012). The transcript of this hearing, as well as comments submitted to the hearing docket, are available at http://www.regulations.gov, docket number FDA-2012-N-1037. FDA considered carefully the input presented at this hearing, as well as the comments submitted to the hearing docket, in creating the list of qualifying pathogens. 1 In addition, FDA consulted with experts in infectious disease and antibiotic resistance at CDC and NIH during the development of both the proposed and the final rule.

On June 12, 2013, FDA published the proposed rule, “Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act” (78 FR 35155). In the proposed rule, the Agency set forth the factors it proposed to consider and the methodology it proposed to use in establishing the list of qualifying pathogens, as well as its interpretation of statutory language. The Agency concluded with extensive analyses of the 18 pathogens proposed for inclusion on the list of “qualifying pathogens.” FDA's decisions regarding the proposed rule are described in sections III.A, III.B, III.C, and IV.

After reviewing the comments submitted to the docket (see section IV), the Agency has decided to finalize the proposed factors for consideration and methodology for establishing the list of qualifying pathogens, and has reiterated them below for convenience.

As stated previously, section 505E(f)(2)(B)(i) of the FD&C Act requires FDA to consider the following factors in establishing and maintaining the list of qualifying pathogens:

• The impact on the public health due to drug-resistant organisms in humans;

• the rate of growth of drug-resistant organisms in humans;

• the increase in resistance rates in humans; and

• the morbidity and mortality in humans.

The Agency recognizes it is important to take a long-term view of the drug resistance problem. For some pathogens, particularly those for which increased resistance is newly emerging, FDA recognizes that there may be gaps in the available data or evidence pertaining to one or more of the four factors described in section 505E(f)(2)(B)(i) of the FD&C Act. Thus, consistent with GAIN's purpose of encouraging the development of treatments for serious or life-threatening infections caused by bacteria or fungi, the Agency intends to consider the totality of available evidence for a particular pathogen to determine whether that pathogen should be included on the list of qualifying pathogens. Therefore, if, after considering the four factors identified in section 505E(f)(2)(B)(i) of the FD&C Act, FDA determines that the totality of available evidence demonstrates that a pathogen “has the potential to pose a serious threat to public health,” the Agency will identify the pathogen in question as a “qualifying pathogen.” More detailed explanations of each factor identified in section 505E(f)(2)(B)(i) of the FD&C Act are set forth in the paragraphs that follow.

This first factor that section 505E(f)(2)(B)(i) of the FD&C Act requires FDA to consider is also the broadest. Many factors associated with infectious diseases affect public health directly, such as a pathogen's ease of transmission, the length and severity of the illness it causes, the risk of mortality associated with its infection, and the number of approved products available to treat illnesses it causes. Additionally, although the Agency did not consider financial costs in its analyses for this proposed list of qualifying pathogens, we note that the published literature supports the conclusion that antimicrobial-resistant infections are associated with higher healthcare costs (see, e.g., Refs. 1 and 2; Ref. 3 at pp. 807, 810, 812).

In considering a proposed pathogen's impact on the public health due to drug-resistant organisms in humans, FDA will assess such evidence as: (1) The transmissibility of the pathogen and (2) the availability of effective therapies for treatment of infections caused by the pathogen, including the feasibility of treatment administration and associated adverse effects. However, FDA also may assess other public health-related evidence, including evidence that may indicate a highly prevalent pathogen's “potential to pose a serious threat to public health” due to the development of drug resistance in that pathogen, even if most documented infections are currently drug susceptible.

The second and third factors that FDA must consider overlap substantially with one another and, for the most part, are assessed using the same trends and information. Therefore, the Agency will analyze these factors together.

In considering these factors with respect to a pathogen, FDA will assess such evidence as: (1) The proportion of patients whose illness is caused by a drug-resistant isolate of a pathogen (compared with those whose illness is caused by more widely drug-susceptible pathogens); (2) the number of resistant clinical isolates of a particular pathogen (e.g., the known incidence or prevalence of infection with a particular resistant pathogen); and (3) the ease and frequency with which a proposed pathogen can transfer and receive resistance-conferring elements (e.g., plasmids encoding relevant enzymes, etc.). Given the temporal limitations on infectious disease data, FDA also will consider evidence that a given pathogen currently has a strong potential for a meaningful increase in resistance rates. Evidence of the potential for increased resistance may include, for example, projected (rather than observed) rates of drug resistance for a given pathogen, and current and projected geographic distribution of a drug-resistant pathogen. Furthermore, in acknowledgement of the growing problem of drug resistance, FDA also may assess other available evidence demonstrating either existing or potential increases in drug resistance rates.

Patients infected with drug-resistant pathogens are inherently more challenging to treat than those infected with drug-susceptible pathogens. For example, in some cases, a patient infected with a drug-resistant pathogen may have a delay in the initiation of effective drug therapy that can result in poor outcomes for such patients. Consequently, in determining whether a pathogen should be included on the list, FDA will consider the rates of mortality and morbidity (the latter as measured by, e.g., duration of illness, severity of illness, and risk and extent of sequelae from infections caused by the pathogen, and risk associated with existing treatments for such infections) associated with infection by that pathogen generally—and particularly by drug-resistant strains of that pathogen.

Setting quantitative thresholds for inclusion on the list based on any prespecified endpoint would be inconsistent with FDA's approach of considering a totality of the evidence related to a given pathogen, as well as infeasible given the variety of pathogens under consideration. Instead, in considering whether this factor weighs in favor of including a given pathogen, the Agency will look for evidence of a meaningful increase in morbidity and mortality rates when infection with a drug-resistant strain of a pathogen is compared to infection with a more drug-susceptible strain of that pathogen. The Agency may also assess other evidence, such as overall morbidity and mortality rates for infection with either resistant or susceptible strains of a pathogen to determine whether that pathogen has the potential to pose a serious threat to public health, in particular if drug-resistant isolates of the pathogen were to become more prevalent in the future.

As FDA explained in the proposed rule (78 FR 35155 at 35156) and affirms in this final rule, the statutory standard for inclusion on FDA's list of qualifying pathogens is different from the statutory standard for QIDP designation. QIDP designation, by definition, requires that the drug in question be an “antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections” (section 505E(g) of the FD&C Act). “Qualifying pathogens” are defined according to a different statutory standard; the term means “a pathogen identified and listed by the Secretary . . . that has the potential to pose a serious threat to public health” (section 505E(f) of the FD&C Act) (emphasis added). That is, a drug intended to treat a serious or life-threatening bacterial or fungal infection caused by a pathogen that is not included on the list of “qualifying pathogens” may be eligible for designation as a QIDP, while a drug that is intended to treat an infection caused by a pathogen on the list may not always be eligible for QIDP designation. After reviewing the comments to the docket on this point (see section IV.A), FDA's understanding of these statutory standards remains unchanged.

To alleviate confusion regarding this issue, FDA also clarifies that vaccine applications are ineligible for QIDP designation under the GAIN title of FDASIA. Vaccines are biological products whose applications for approval are submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). QIDPs, however, must be human drugs whose applications are submitted pursuant to section 505(b) of the FD&C Act. Thus, under the law, vaccines are ineligible for QIDP designation.

As stated in the proposed rule (78 FR 35156) and affirmed in this final rule, FDA intends the list of qualifying pathogens to reflect the pathogens that, as determined by the Agency, after consulting with other experts and considering the factors set forth in FDASIA (see section 505E(f)(2)(B)(i) of the FD&C Act), have the “potential to pose a serious threat to public health” (section 505E(f)(1) of the FD&C Act). FDA does not intend for this list to be used for other purposes, such as the following: (1) Allocation of research funding for bacterial or fungal pathogens; (2) setting of priorities in research in a particular area pertaining to bacterial or fungal pathogens; or (3) direction of epidemiological resources to a particular area of research on bacterial or fungal pathogens. Furthermore, as section 505E of the FD&C Act makes clear, the list of qualifying pathogens includes only bacteria or fungi that have the potential to pose a serious threat to public health. Viral pathogens or parasites, therefore, were not considered for inclusion and are not included as part of this list.

FDA's proposed rule concluded with an analysis of the 18 pathogens the Agency proposed to identify as qualifying pathogens. After reviewing the comments to the docket (see section IV.C), FDA is finalizing its analyses of the 18 proposed pathogens as written in the proposed rule (see 78 FR 35155 at 35158 through 35166), which are incorporated by reference herein, and is identifying all 18 proposed pathogens as “qualifying pathogens” in § 317.2 (21 CFR 317.2).

In response to comments, FDA has added three additional pathogens ( Coccidiodes species, Cryptococcus species, and Helicobacter pylori ) to the list of qualifying pathogens (see section IV.D).

After the publication of the proposed rule on June 12, 2013, 18 comments from pharmaceutical companies, lawmakers and governmental organizations, infectious disease specialists, public interest groups, and other members of the public were submitted to the docket via http://www.regulations.gov during the 60-day comment period. FDA has summarized and responded to these comments below. To make it easier to identify the comments and FDA's responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before the Agency's response. We have numbered each comment to help distinguish between different comments. Similar comments are grouped together under the same number, and, in some cases, different subjects discussed in the same comment are separated and designated as distinct comments for purposes of FDA's responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.

(Comment 1) One comment criticized FDA's interpretation of the statute that not all treatments for infections caused by qualifying pathogens will be eligible for QIDP designation, and that “the development of a treatment for an infection caused by a pathogen included on the list of `qualifying pathogens' is neither a necessary nor a sufficient condition for obtaining QIDP designation” (78 FR 35515 at 35167). The comment first expressed concern that, because the terms “serious” and “life-threatening” are not separately defined by statute, their meanings could change in the future. The comment contrasted this alleged uncertainty with the statute's detailed definition and identification process for “qualifying pathogens,” asserting that the collective term “serious or life-threatening infections” includes infections caused by qualifying pathogens. Thus, the comment asserted, Congress intended the qualifying pathogen list to provide “some certainty and transparency” regarding which products may be eligible for QIDP designation.

(Response) FDA agrees with the comment that the term “serious or life-threatening” is not explicitly defined in the statute. Nevertheless, the Agency has been interpreting and applying these terms in the context of other programs under the Food, Drug, and Cosmetic Act intended to expedite the development of drugs and biologics to address unmet medical needs for several years. “Serious or life-threatening” is used in section 506 of the FD&C Act, in the context of expedited programs, including fast track designation. The term “serious” is further defined in a 2006 FDA guidance for industry, “Fast Track Drug Development Program—Designation, Development, and Application Review (which will be superseded by the draft guidance for industry, “Expedited Programs for Serious Conditions—Drugs and Biologics,” when finalized) and in the preamble to a final rule pertaining to accelerated approval (57 FR 58942, December 11, 1992). The term “life-threatening” is defined in 21 CFR 312.81(a). The provisions related to QIDPs in GAIN similarly seek to incentivize the development of drugs to meet an unmet medical need and, indeed, QIDP-designated applications are eligible for both priority review and fast-track designation (see section 524A of the FD&C Act and section 506(b)(1) of the FD&C Act, as amended). The Agency intends, therefore, to interpret serious or life-threatening in a similar manner with respect to GAIN as it has in the context of these expedited programs. While guidances and even regulations may change, the Agency may not apply different definitional standards to similarly situated applicants or applications. Thus, concerns over lack of a statutory definition of “serious or life-threatening” are an insufficient basis for FDA to change its interpretation of the statute.

Further, it may be true that many of the qualifying pathogens listed by FDA may cause serious or life-threatening infections for which treatments might be eligible for QIDP designation. However, the comment's assertions cannot change the language that is in the statute, which provides different standards for QIDPs and qualifying pathogens. Qualifying pathogens are “ pathogen[s] . . . that ha[ve] the potential to pose a serious threat to public health,” whereas QIDPs are certain human “ drugs . . . intended to treat serious or life-threatening infections” (emphasis added). Most importantly, many pathogens with the potential to seriously threaten public health may cause varying levels of morbidity and mortality in a given individual depending on the site of infection, the person infected, the level of antimicrobial resistance present in the infecting pathogen, and other factors.

(Comment 2) One comment stated that only “factors that can be addressed through new drug development” should be used as criteria for including pathogens on the list. The comment does not specify which factors these are, but the comment's concerns stem from an assertion that new drugs contribute to antibiotic resistance due to their off- label use, use in patients who do not need the drugs, or use in patients whose underlying infection is unidentified.

(Response) FDA agrees that good antibiotic stewardship is critical in reducing antibiotic resistance rates. However, the mandatory statutory considerations specified in section 505E(f)(2)(B)(i) of the FD&C Act are not limited to factors that can be addressed only through new drug development. FDA will make no changes to the rule based on this comment.

(Comment 3) One comment asserted that rarely used, non-“standard of care” drugs should be considered in assessing the therapies available to treat a given pathogen. FDA understands this comment to mean that FDA should include, in its assessment of available therapies for infections by particular pathogens, drugs that may treat those infections but nevertheless are not considered “standard of care” therapies.

(Response) FDA considers the number of approved products available to treat infectious diseases caused by a pathogen when assessing the impact on the public health due to drug-resistant bacterial or fungal pathogens in humans. For the purposes of this list of qualifying pathogens, at this time, FDA will not consider unapproved products or off-label use of products approved for another indication. FDA will make no changes to the rule based on this comment.

(Comment 4) One comment agreed that incentives authorized by GAIN for the creation of new antibacterial and antifungal drugs should focus on drugs that treat serious or life-threatening infections.

(Response) FDA responds by confirming that QIDP designation, which is a prerequisite to the incentives authorized by GAIN, may be made for “antibacterial or antifungal drug[s] for human use intended to treat serious or life-threatening infections” (section 505E(g) of the FD&C Act). FDA will make no changes to the rule in response to this comment.

(Comment 5) Another comment found FDA's proposed methodology and rationale for inclusion of qualifying pathogens to be favorable, and agreed with the Agency that the statute provides different definitions for “qualifying pathogens” and QIDPs. The comment also asserted that having QIDP designation depend on intended indication (i.e., treatment of serious or life-threatening infections) is what reflects statutory intent, rather than having QIDP status depend on targeting specific pathogens.

(Response) FDA agrees with the points made in this comment. FDA's interpretation and application of the GAIN provision is consistent with the intent of the statute, which is to use exclusivity and other incentives to spur development of the most urgently needed treatments, i.e., those treating serious or life-threatening infections. The Agency will make no changes to the proposed rule as a result.

(Comment 6) One comment pointed out that FDA did not provide a basis for excluding the pathogens not listed on the qualifying pathogen list. The comment also stated that FDA “fails to mention” how the pathogens on the qualifying pathogen list and the pathogens not on the qualifying pathogen list may relate to other pathogen lists (e.g., those pertaining to bioterrorism).

(Response) FDA reiterates that the focus of this rulemaking is to fulfill statutory requirements to: (1) Establish and maintain a list of “qualifying pathogens” that have “the potential to pose a serious threat to public health” and (2) make public the methodology for developing the list (see section 505E(f) of the FD&C Act). Other pathogen lists, including CDC's list of bioterrorism agents/diseases, have different purposes and standards. FDA will not, nor is it required to, make comparisons between and among the qualifying pathogen list (or the pathogens not appearing on the list) and “additional lists” of pathogens.

In responding to comments received on the proposed rule, however, the Agency will explain why it either accepted or rejected comment requests to add particular pathogens.

For the foregoing reasons, FDA will make no changes to the contents of the proposed rule based on this comment.

(Comment 7) One comment asserted that pathogens with approved “reserve antibiotics” should “not automatically count as qualifying pathogens.” FDA understands this comment to suggest that pathogens whose infections may be treated with “reserve antibiotics” (i.e., antibacterial drugs that are placed “in reserve” for those patients who have very limited options for treatment of their bacterial infections, but are not widely used to treat patients who have many antibacterial treatment options available to treat their bacterial infections) should not be on the list of qualifying pathogens.

(Response) In making its “qualifying pathogen” determinations, FDA does consider the therapies—including “reserve antibiotics”—that are available and indicated to treat infections with a given pathogen. Nevertheless, the fact that some pathogens already have approved antimicrobial therapies available is not dispositive of whether a particular pathogen meets the several statutory criteria FDA must assess. Furthermore, as a general matter, subsequent new drug development following the first drug approval could address important public health issues in patients with unmet need based on one or more of the following considerations:

• Alternative drugs may be needed to treat special populations (e.g., renal impairment) or patients for whom drug interactions are a concern.

• Some patients may experience an adverse drug effect and be unable to complete the course of therapy.

• Some patients may have an allergy to certain drugs and need alternatives.

• In some circumstances, drug production issues may arise that affect supply for a drug.

• New information may become evident postmarketing that has an impact on risk/benefit for some patients.

(Comment 8) One comment stated that “when new therapies are created and used to treat qualifying pathogens, these should be removed from the list.”

(Response) FDA interprets this comment to mean that, as soon as FDA approves a new drug to treat an infection caused by one of the qualifying pathogens, that pathogen should be removed from the list. FDA responds by noting that the availability of effective therapies for treating infections with a given pathogen is merely one consideration among many that FDA considers in determining whether a pathogen should be designated a “qualifying pathogen.” While important to FDA's assessment, the availability of effective therapies does not determine whether a qualifying pathogen should remain on the list. FDA will reassess the list of qualifying pathogens “every 5 years, or more often as needed,” according to the requirements of the statute (see 505E(f)(2)(C) of the FD&C Act), and declines to establish a single-standard trigger for removing pathogens from the list.

(Comment 9) One comment asserted that regardless of QIDP designation status, “drugs intended to treat qualifying pathogens” (which we assume to mean drugs intended to treat infections caused by qualifying pathogens) should be required to prove reduction in mortality or morbidity. The comment further asserted that clinical trials in anti-infective drugs for qualifying pathogens should have mortality as the primary endpoint.

(Response) These concerns apply to approval standards for particular drugs, which are required to be safe and effective within the meaning of section 505 of the FD&C Act. These concerns do not apply to the subject matter of the proposed rule, which is the method for identifying qualifying pathogens and the resulting list. Thus, FDA considers them irrelevant to the present rulemaking and will make no changes to the rule as a result.

(Comment 10) One comment suggested edits and new literature references to a paragraph in the preamble to the proposed rule pertaining to the analysis of Enterobacteriaceae. These references are:

• A 2013 article by M. Sjölund Karlsson et al., “Outbreak of Infections Caused by Shigella sonnei with Reduced Susceptibility to Azithromycin in the United States,” in Antimicrobial Agents and Chemotherapy (Ref. 4);

• a 2010 article by M. R. Wong et al., “Antimicrobial Resistance Trends of Shigella Serotypes in New York City, 2006-2009,” in Microbial Drug Resistance (Ref. 5); and

• a 2007 article by S. D. Alcaine et al., “Antimicrobial Resistance in Nontyphoidal Salmonella,” in Journal of Food Protection (Ref. 6).

(Response) FDA appreciates the comment and suggested literature references in support of FDA's decision to add Enterobacteriaceae to the list of qualifying pathogens. We agree that the three suggested literature references provide additional support for the inclusion of Enterobacteriaceae on the list of qualifying pathogens. Specifically, FDA agrees that the Karlsson and Wong references support recognition of an increase in Shigella resistance in the United States, and that the Alcaine reference supports recognition of an increase in Salmonella resistance. FDA thus incorporates these references as part of its basis for designating species in the Enterobacteriaceae family as qualifying pathogens. The comment did not provide specific NARMS data or specific references presenting relevant NARMS data, but rather made general reference to the surveillance project. FDA, thus, declines to incorporate the NARMS database in its entirety as part of its basis for designating species in the Enterobacteriaceae family as qualifying pathogens.

(Comment 11) Two comments made suggestions in response to FDA's inclusion of Clostridium difficile on the list of qualifying pathogens. One advocated improvements in hospital hygiene (e.g., hand washing) and staffing to reduce the spread of C. difficile. The other advocated an unidentified procedure for treatment of C. difficile and expressed concerns that the proposed rule would inhibit the use of this treatment.

(Response) FDA responds by thanking the commenters for their input. The proposed rule, however, describes the Agency's methodology for identifying qualifying pathogens and developing the resulting list. The propose rule does not address matters on hospital hygiene standards and non-pharmacologic procedures. Therefore, FDA will make no changes to the rule in response to these comments.

(Comment 12) One comment suggested adding Mycobacterium abscessus to the list of qualifying pathogens.

(Response) M. abscessus is a species of non-tuberculous mycobacteria, a category of pathogens already on the proposed list of qualifying pathogens in FDA's June 2013 proposed rule. As described in the proposed rule, FDA believes that non-tuberculous mycobacteria (including M. abscessus ) meet the statutory standards for identification as “qualifying pathogens,” and this final rule adds non-tuberculous mycobacteria (including M. abscessus ) to the list of qualifying pathogens (see 78 FR 35155 at 35163).

(Comment 13) One comment suggested adding Proteus mirabilis to the list of qualifying pathogens.

(Response) P. mirabilis is a species in the Enterobacteriaceae family, a category of pathogens already on the proposed list of qualifying pathogens in FDA's June 2013 proposed rule (see 78 FR 35155 at 35161). As described in the proposed rule, FDA believes that Enterobacteriaceae (including P. mirabilis ) meet the statutory standards for identification as “qualifying pathogens,” and this final rule adds Enterobacteriaceae (including P. mirabilis ) to the list of qualifying pathogens.

(Comment 14) One comment stated that “poor adherence to therapy, overuse of currently available therapy, and empiric use” should not be used in support of identifying a pathogen for inclusion on the list of qualifying pathogens—particularly M. tuberculosis —because these “relate to clinical practice.”

(Response) FDA considers antibiotic stewardship and attention to patient adherence to therapy as important factors in determining transmissibility. FDA explained in the preamble to the proposed rule (see 78 FR 35155 at 35157) that a pathogen's ease of transmission is an important consideration in evaluating “the impact on the public health due to drug-resistant organisms in humans” (section 505E(f)(2)(B)(i) of the FD&C Act). This factor is one of the four statutory factors identified in section 505E(f)(2)(B)(i) of the FD&C Act. Therefore, FDA will make no changes to the rule in response to this comment.

One comment suggested adding Bacteroides, Fusobacterium, and Prevotella species to the list of qualifying pathogens.

(Response) For the reasons that follow, FDA will not add these species to the list of qualifying pathogens. A discussion of these three bacterial pathogens is provided together for the following reasons: (1) These bacterial pathogens are representative of a group of medically-important gram-negative anaerobic rods (see Ref. 7 at pp. 3111-3120) and (2) common taxonomic characteristics (Ref. 8 at pp. 179-194).

These bacterial pathogens are commonly found in the mucous membranes (Ref. 9), particularly in the mouth ( Bacteroides, Fusobacterium, and Prevotella ), intestines ( Bacteroides ), and female urogenital tract ( Bacteroides, Fusobacterium, and Prevotella ) (Ref. 7 at p. 3112). Each of these bacterial pathogens can cause the same infectious diseases and are often implicated in odontogenic infections (particularly for those with poor dental hygiene or periodontal disease, as these bacteria populate dental plaque), peritonsilar infections, and polymicrobial abdominal infections, among others. Particularly when introduced into compromised tissue (e.g., via a wound or break in mucous membranes), these pathogens can cause abscesses that may require drainage or debridement in addition to antimicrobial therapy (Ref. 7 at p. 3117). Infection prevention is often the focus for these pathogens—either via “avoiding conditions that reduce the redox potential of the tissues” or preventing the bacteria from entering wounds, often by administering prophylactic antimicrobial agents prior to surgery or dental work (Ref. 9).

In general, infections from these pathogens are not transmitted from one person to another or acquired from the environment, but rather occur from a person's own mucosal flora (id.). These infections, once established, are generally able to be treated successfully with surgical incision and drainage as well as administration of antimicrobial agents and treatment of underlying comorbid conditions (Ref. 7 at pp. 3111-3119 and Ref. 10). There have been reports of increases in the incidence of bacteremia caused by anaerobic pathogens (a classification that includes Bacteroides, Fusarium, and Prevotella species) (Ref. 11). However, these increases appear more likely to reflect the complex patient populations studied (id. at p. 898) rather than, for example, underlying changes in the species' transmissibility, pathogenicity or other characteristics that would likely signal a potential for meaningful increase in colonization rates or active infections.

Resistance to antimicrobial agents has been reported in the species of these genera, however (Ref. 9). For example, plasmid-mediated resistance has been seen in Bacteroides species (id.). Beta-lactamase production has been seen in Bacteroides species (see Refs. 12 and 13) and in Prevotella isolates (albeit less frequently than in Bacteroides isolates); Fusobacterium species have the lowest incidence of beta-lactamase production of the three genera (Refs. 12, 13, 14, and 15). Resistance to clindamycin and cefoxitin also has been noted in all three genera (Ref. 15). Nevertheless, while there have been suggestions of increasing resistance over time (Ref. 16), and while there is some concern regarding rates of resistance to penicillin and clindamycin, these bacteria still remain susceptible to many drugs (Refs. 12, 13, and 14). Furthermore, persuasive clinical data that may indicate poorer outcomes for resistant infections are lacking.

Taken together, the available data do not provide a compelling rationale for concluding that Bacteroides, Prevotella, or Fusobacteria species have the potential to pose a serious threat to public health within the meaning of the statute. Thus, FDA declines to include them on the list of qualifying pathogens at this time.

One comment suggested adding Brucella species to the list of qualifying pathogens.

(Response) Unlike the pathogens previously proposed as qualifying pathogens, Brucella infections remain susceptible to and may be treated by existing antibacterial drugs. Further, the incidence and prevalence of brucellosis is low enough that Brucella species are unlikely to pose a serious threat to public health—even if resistance were to emerge. Thus, for these reasons and those that follow, FDA declines to identify Brucella species as qualifying pathogens.

Bacteria of the genus Brucella are gram-negative coccobacilli that typically colonize animals (Ref. 7 at p. 2921). Rarely, certain Brucella species (most frequently B. melitensis ) may infect humans. In these cases, infection often occurs when broken human skin comes in contact with infected animals or animal fluids, when a person inhales aerosolated bacteria, or when a person consumes unpasteurized dairy products (id.). Brucellosis generally causes nonspecific constitutional symptoms (e.g., malaise, fever, headache, anorexia) and can cause more serious arthritis, central nervous system infection, and hepatitis, among other conditions and symptoms (Ref. 7 at p. 2922). Brucella infections are usually not transmitted person-to-person (Ref. 7 at p. 2921); therefore, the people at highest risk of Brucella infections include those who consume unpasteurized dairy products or who work with animals or the bacteria itself: Ranchers, veterinarians, lab researchers, and slaughterhouse workers, i.e., isolated environmental exposures (id.).

The incidence of human brucellosis remained stable from 1990 to 2003 (Ref. 17), increased from 2003-2007, and decreased by 36 percent in 2008 (Ref. 18). FDA is aware of no data that suggest a meaningful post-2008 increase in Brucella infection in humans—to the contrary, recent data suggest that infections have decreased from 2012 to 2013 (Ref. 19 at Table 1)—and the overall prevalence of brucellosis remains low in the United States (Ref. 7 at p. 2921). Brucella species have been listed as a category B (second-highest priority) bioterrorism threat on CDC's list of bioterrorism agents (Ref. 20), but this classification takes into account such elements as ease of dissemination of the pathogen (e.g., it can be aerosolized) in a bioterrorism setting, and the need for CDC's enhancement of diagnostic and surveillance capabilities (id.). Importantly, this classification also recognizes that brucellosis causes only “moderate morbidity rates and low mortality rates” (id.). Indeed, although brucellosis may require long courses of treatment (e.g., 6 weeks or more) and can involve tissue sites that enhance the difficulty of treatment (e.g., central nervous system infection), the prognosis for Brucella infection is generally favorable with appropriate treatment (Ref. 21).

Treatment recommendations for brucellosis have remained unchanged for many years and include the use of tetracycline or doxycycline plus gentamycin, or doxycycline plus rifampin (id.). Despite occasional overseas reports of resistance (Refs. 22 and 23), Brucella species generally remain susceptible to the mainstays of brucellosis treatment, even abroad (Refs. 24, 25, 26, and 97). In FDA's view, the currently available data do not demonstrate widespread antimicrobial resistance in Brucella infections, nor do they support the potential for a meaningful increase in drug resistance for Brucella species.

Thus, for the foregoing reasons, FDA will not identify Brucella species as qualifying pathogens.

One comment suggested adding Clostridium species other than C. difficile to the list of qualifying pathogens.

(Response) For the reasons that follow, FDA declines to add non- difficile Clostridium species to the list of qualifying pathogens.

There are over 200 non- difficile species of the bacterial genus Clostridium. These toxin-producing, anaerobic rods are found in soil and in normal human and animal flora, and often infect or intoxicate humans via contaminated food or wounds (Ref. 7 at p. 3103), although mother-to-child transmission has been identified for such pathogens as C. tetani. These pathogens cause a variety of diseases or conditions, including: Food poisoning ( e.g., C. perfringens ), including botulism ( C. botulinum ); tetanus ( C. tetani ); clostridial myonecrosis, also called gas gangrene ( C. perfringens ); bloodstream infections ( C. perfringens and C. septicum) (Ref. 7 at pp. 3091-3092, 3097-3098, 3106-3107); and, less commonly, toxic shock syndrome ( C. sordellii ) (Ref. 27).

Non- difficile Clostridium outbreaks are reported from time to time (Ref. 28), but foodborne C. perfringens infections are the most common, causing approximately 1 million cases of mostly mild to moderate gastroenteritis in the United States each year (Ref. 29). C. perfringens often colonizes meat or poultry, and illness may result from large volumes of food kept warm for a long period of time (e.g., in buffets) (id.) or in outbreaks associated with particular prepared foods (Refs. 30 and 31). C. botulinum, which also causes food poisoning, is relatively rare, though much more severe—it is likely fatal if untreated (Refs. 29 and 32), whereas C. perfringens infections are often self-limited and require simply oral rehydration and supportive care at home. Other Clostridium -related diseases, such as tetanus, bloodstream infections, and gas gangrene, are life-threatening and require immediate treatment.

Some infections caused by Clostridium species are very rare. For example, less than 200 cases of botulism were reported annually to the CDC, and less than 50 cases of tetanus were reported annually to the CDC, in each of the past 5 years (Ref. 19). While CDC does not require reporting of other clostridial infections, antimicrobial susceptibility studies “have not changed significantly over the past 10 years” (Refs. 19 and 33).

In contrast with C. difficile, C. perfringens is not transmitted from human to human (Refs. 34, 35, and 36), 2 and FDA is unaware of significant increases in incidence or prevalence of infections with C. perfringens or other non- difficile Clostridium pathogens.

There have been reports of limited antimicrobial resistance in non- difficile Clostridium species (Refs. 15, 37, 38, 39, and 40), and studies have found that resistance genes may (or may potentially) be transferred between C. perfringens species (Refs. 41 and 42). However, many reports of resistant isolates do not offer a correlation either with resistant infections seen in a clinical setting (Ref. 40) or with suggestions of worse outcomes in patients with resistant infections (Ref. 39) (particularly for C. perfringens, whose infections rarely require treatment, and for which antibacterial therapy is not recommended). Many therapies still remain available and effective for treating the more severe non- difficile Clostridium infections, and, limited in vitro resistance reports notwithstanding, FDA has not seen evidence that there is a strong potential for a meaningful increase in resistance rates in these pathogens.

For the foregoing reasons—and particularly when contrasted with the considerations described in the proposed rule pertaining to C. difficile —FDA does not believe there are sufficient data available to find that non- difficile Clostridium species meet the statutory standard for listing as qualifying pathogens. Thus, FDA will not include these pathogens on the list of qualifying pathogens.

Six comments suggested adding Coccidioides immitis to the list of qualifying pathogens. Six comments suggested adding C. posadasii to the list of qualifying pathogens. One comment suggested adding Coccidioides species (generally) to the list of qualifying pathogens. According to the comments, Coccidioides species present a serious and growing public health concern, particularly in the southwestern United States.

(Response) FDA agrees with the comments and will include Coccidioides species on the list of qualifying pathogens.

Coccidioides species are pathogenic fungi that are endemic to certain regions of southwestern United States (i.e., certain areas of California, Arizona, New Mexico, Texas, Utah, and Nevada) and other regions of the Western Hemisphere (Ref. 7 at pp. 3333-3334). The pathogen is responsible for causing coccidioidomycosis, also known as Valley Fever, with C. immitis and C. posadasii as the causative agents. Coccidioides species is acquired via respiratory inhalation of spores.

Infections caused by Coccidioides species have increased in the past decade. It is estimated that up to 60 percent of people living in the endemic areas of southwestern United States have been exposed to the fungus (Ref. 43). According to a March 2013 report, the CDC found that more than 20,000 cases of Valley Fever are reported annually in the United States, but many cases go unreported (Ref. 44). Some researchers estimate that the fungus infects more than 150,000 people each year (Ref. 45). The CDC observed that the incidence of reported Valley Fever increased substantially between 1998 and 2011, from 5.3 per 100,000 people in the endemic area in 1998 to 42.6 per 100,000 in 2011 (Ref. 44). Although some of the increase can be attributed to changes in the case definition based on serologic evidence of infection (Ref. 46), the incidence of infections caused by the fungi continued to increase even after taking into account the change in the case definition. Notably, the CDC found that the incidence of reported Valley Fever increased in Arizona and California from 2009 to 2010 and from 2010 to 2011 (Ref. 44).

Of the infections, one-half to two-thirds are subclinical (Ref. 45). Symptomatic patients typically experience a self-limited acute or subacute community-acquired pneumonia that becomes evident 1 to 3 weeks after infection (id.), with fever, cough, headache, rash, muscle aches, and joint pain as typical symptoms (Ref. 47). Some patients develop severe or chronic pulmonary disease, and less than one percent of patients experience extrapulmonary infection (Ref. 44). Chronic pulmonary or disseminated disease can occur months or years after the initial infection (Ref. 48). For extrapulmonary disease (also referred to as disseminated disease), estimates range as high as 30 to 50 percent of “infections for heavily immunosuppressed patients, such as those with AIDS, lymphoma, receipt of a solid-organ transplant, or receipt of rheumatologic therapies, such as high-dose corticosteroids or anti-tumor-necrosis-factor (TNF) medications” (Ref. 45).

In a 2007 to 2008 population-based study in Arizona, over 40 percent of patients with Valley Fever required hospitalization, and symptoms lasted a median of 120 days (Ref. 49). Furthermore, between 1998 to 2008, the annual number of coccidioidomycosis-related deaths was about 163, with the highest risk of death associated with men, persons aged 65 or greater, Hispanics, Native Americans, and residents of Arizona or California (Ref. 50).

Resistance mechanisms for Coccidioides species have not been identified (Ref. 51). There is evidence of at least one report of resistance to the azole class of antifungal agents (id.). In a retrospective analysis of patients presenting with coccidioidal meningitis at Los Angeles, CA, hospitals, researchers found that a significant proportion of patients—40 percent—died, despite treatment with fluconazole monotherapy or a combination of fluconazole and intravenous amphotericin B (Ref. 52). Therefore, it is plausible that resistance has increased given the increase in the rate of growth of Valley Fever.

For the reasons stated previously, FDA believes that Coccidioides species has the potential to pose a serious threat to public health, and FDA is including Coccidioides species on the list of qualifying pathogens.

Two comments suggested adding Cryptococcus species to the list of qualifying pathogens due to, among other things, C.gattii infections in North America and concerns about worldwide morbidity and mortality from cryptococcal infections generally.

(Response) For the reasons that follow, FDA will include these species as qualifying pathogens.

Cryptococcus species are encapsulated yeast fungi (Ref. 7 at p. 3287). Although there are 19 species in the genus (Ref. 7 at p. 3287), C. neoformans and C. gattii are the two generally associated with human disease (Ref. 7 at pp. 3288-3289). Both species are found in soil, and infection typically occurs via inhalation of the fungi (Ref. 7 at p. 3290). Cryptococcal disease often presents as lung or central nervous system disease (Ref. 7 at p. 3293), although the pathogens also can infect other parts of the body (Ref. 53).

Most C. neoformans occur in immunocompromised patients (Ref. 7 at p. 3289), and C. neoformans meningitis cases are very rare in healthy people, with an incidence of only 0.4 to 1.3 per 100,000 people (Ref. 54). Incidence of cryptococcal disease increased substantially with the HIV/AIDS epidemic in the late portion of the 20th century and remains high in developing countries, where antiretroviral therapy is scarce (id.). In developed countries, the use of antiretroviral therapy has reduced the number of end-stage HIV/AIDS patients susceptible to cryptococcal infection (Ref. 55); incidence rates in this population in the United States are between 2 and 7 infections per 100,000 people (Ref. 54). Although HIV/AIDS-related cryptococcosis is declining, an increasing population (Ref. 53) of immunosuppressed patients—including solid organ transplant patients, cancer patients, and patients on corticosteroids—remain at risk of C. neoformans infections (Ref. 56). Non-HIV patients appear to bear an increasing burden of cryptococcal disease, representing 16 percent of all U.S. cryptococcal meningitis cases in 1997 but 29 percent of all U.S. cryptococcal meningitis cases in 2009 (Ref. 55). Cryptococcosis is the third most common invasive fungal infection in solid organ transplant patients after candidiasis and aspergillosis (Ref. 56).

C. gattii infections, however—which had been considered geographically limited to areas such as Australia and New Zealand because of an association with eucalyptus trees (Ref. 57)—have become an increasing public health concern for healthy, rather than immunocompromised, people in North America. Although C. gattii infections also have been documented in HIV patients, “[t]he emergence of C. gattii infections in immunocompetent human and animal populations in the Pacific Northwest region of North America is nothing short of remarkable” (Ref. 56). After an initial outbreak on Vancouver Island in 1999, incidence rates of C. gattii infections were estimated to be 37 times higher than in the endemic areas of Australia and New Zealand (Ref. 53). A retrospective analysis in the Pacific Northwest area of the United States did not identify any patients with cryptococcal infection due to C. gattii before 2000 (Ref. 58), while 100 infections were documented in the United States between 2004 and 2011, mostly from the Pacific Northwest area of the United States (Ref. 98).

Both C. neoformans and C. gattii can cause life-threatening infections, although the primary infection sites may differ. For example, in the initial Vancouver Island outbreak of C. gattii infections about 70 percent of patients had lung disease (Ref. 53), and in C. neoformans infections in immunocompromised patients (who comprise the majority of those infected), meningitis or other central nervous system disease is the most common presentation of infection (id.). Those C. gattii patients who have central nervous system involvement may have more neurological sequelae than C. neoformans patients, however (id.). These sequelae may require longer courses of antifungal therapy to treat (id.), and may result in permanent neurological damage (Ref. 59). Regardless of interspecies disease differences, infection with either pathogen is likely to be very serious. In one study of C. gattii infections, 91 percent of infected patients were hospitalized and 33 percent died (Ref. 60). Mortality rates for C. neoformans infections are approximately 12 percent in developed countries, and that rate rises to 50 to 70 percent in sub-Saharan Africa, where treatment is less accessible (Ref. 54).

According to one set of clinical practice guidelines, “[c]ryptococcosis remains a challenging management issue, with little new drug development or recent definitive studies” (Ref. 61). Both pathogens require long courses of antifungal therapy for treatment, although the success and components of therapy may differ somewhat depending on the primary site of infection and the immunological competence and underlying condition of the patient (id.). In recent years, however, studies on both pathogens have indicated signs of increasing resistance to antifungal therapies. For example, according to a 10-year ARTEMIS Global Antifungal Surveillance Program (ARTEMIS) survey, the proportion of C. neoformans isolates showing resistance to fluconazole increased from 7.3 percent in 1997-2000 to 11.7 percent in 2005-2007 (Ref. 62). Furthermore, in one study, C. gattii isolates from the Pacific Northwest were more resistant to antifungal drugs than non-Pacific Northwest C. gattii isolates or C. neoformans isolates (Ref. 63). This result supports the observation that infection with C. gattii strains from the Pacific Northwest may result in worse clinical outcomes than infection with other C. gattii strains (e.g., a 33 percent mortality rate seen in Pacific Northwest infections versus a 13 percent mortality rate seen in infections in Australia) (id.).

In sum, evidence of increasing resistance combined with increases in immunocompromised patients, the emergence of C. gattii infections in the Pacific Northwest in healthy individuals, and the seriousness of cryptococcal disease, have led FDA to conclude that Cryptococcus species have the potential to pose a serious risk to public health. FDA thus will add these pathogens to the list of qualifying pathogens.

One comment suggested adding Fusarium species to the list of qualifying pathogens because the fungal agent causes serious and life-threatening infections.

(Response) Preliminarily, FDA notes that the comment appears to have conflated the standards for qualifying pathogens (“ pathogen[s] . . . that ha[ve] the potential to pose a serious threat to public health” (section 505E(f) of the FD&C Act)) and QIDPs (certain human “ drugs . . . intended to treat serious or life-threatening infections” (section 505E(g) of the FD&C Act)) (emphasis added). For the reasons that follow, FDA declines to add Fusarium species to the list of qualifying pathogens.

Fusarium species are fungi found mainly as saprophytic organisms in soil. Since the 1970s, the number of reports of human infection due to Fusarium species has increased, mainly involving immuocompromised patients (Ref. 7 at p. 3369). Infections caused by Fusarium species occur most commonly in patients with acute leukemia and prolonged neutropenia (id.). The fungi can cause localized infection, deep-seated skin infections, and disseminated disease. The rare cases of disseminated disease have been reported in the clinical settings of severe burns, trauma, and heat stroke (id.). Reports of localized infection in patients without leukemia or prolonged neutropenia are infrequent and usually involve the skin (e.g., complication of a burn) or ocular tissues (Ref. 64).

Inhalation, ingestion, and entry through skin trauma have been suggested as the portal of entry (Ref. 7 at p. 3369). More recently, water has also been suggested as a source of these infections, as the fungus was found in one hospital water supply system and in several water sources at a dialysis clinic (id.). Infection commonly presents with fever and myalgia not responsive to antibacterial therapy during periods of profound neutropenia (id). Skin lesions occur in 60 to 80 percent of infections and can occur within 1 day of the onset of fever (id.). Overall mortality in this infection has been reported to be between 50 to 80 percent (Ref. 7 at p. 3370). Survival is generally associated with the recovery from neutropenia (id.). The high rates of morbidity and mortality are usually due to the patients' underlying immune suppression and prolonged neutropenia (Ref. 65).

Generally, while susceptibility varies among Fusarium species, susceptibility to antifungal drugs generally is thought to be low (Ref. 7 at p. 3370). The management of fusariosis almost always includes surgical debridement, so it is often difficult to ascertain the role of antifungal drugs versus the role of surgical debridement when considering the outcomes of patients with this infection (Ref. 65).

While Fusarium species is associated with high morbidity and mortality rates, there do not appear to be new or changing public health concerns with infections caused by this fungi. Although antifungal therapy plays a role, the standard of care is focused on surgical debridement and reestablishment of the patient's immune system. Therefore, FDA will not be adding Fusarium species to the list of qualifying pathogens.

One comment suggested adding Helicobacter pylori to the list of qualifying pathogens because the pathogen is a major cause of morbidity, specifically a range of gastroduodenal diseases.

(Response) For the reasons that follow, FDA is adding H. pylori to the list of qualifying pathogens.

H. pylori is a gram-negative bacterium that survives in the gastric epithelium or mucosal layer and occasionally in the duodenal or esophageal mucosal epithelium. H. pylori is one of the most common bacterial pathogens, estimated to infect about 60 percent of the world's population (Ref. 66).

About 20 percent of infected individuals develop gastroduodenal disorders in their lifetime (Ref. 67). For symptomatic individuals, H. pylori can cause severe gastric disease, including: Gastritis, duodenal and gastric ulcers, duodenal and gastric cancers, and mucosal-associated-lymphoid-type (MALT) lymphoma (Ref. 68). Approximately 15 percent of infected people will develop a peptic ulcer, and 1 to 3 percent will develop a gastric malignancy during their lifetime (Ref. 69). Persons infected with H. pylori also have a two- to six-times greater risk of developing gastric cancer and MALT lymphoma compared with uninfected individuals (Ref. 68).

Transmission occurs fecal-oral, gastric-oral, or oral-oral from human-to-human contact (Ref. 70). Risk factors include poor socioeconomic conditions, family overcrowding, poor hygiene, and living with an infected family member (id.). Incidence of new infections in developing countries is 3 to 10 percent of the population each year, compared to 0.5 percent in developed countries, due predominantly to better hygiene practices (id.). In the United States, age-adjusted prevalence of H. pylori is higher in Mexican-Americans at 62 percent and non-Hispanic blacks at 53 percent, compared to non-Hispanic whites at 26 percent (Ref. 71).

H. pylori antibiotic resistance has been widely reported at a global level. Resistance mechanisms against antibacterial drugs used to treat H. pylori infections have been identified (Ref. 72). For metronidazole, “high intracellular redox potential of aerobe species prevents the metronidazole reduction-activation and is responsible for the intrinsic resistance” (id.). Prevalence of antibacterial resistance varies in different geographic regions, and it has been correlated with the consumption of antibacterial drugs in the general population (Refs. 73 and 74).

A retrospective analysis of 31 worldwide studies concerning H. pylori published between January 2006 and December 2009 showed substantial rates of antibacterial drug resistance (Ref. 73). For example, 9.6 percent of worldwide H. pylori isolates showed resistance to two or more antibacterial drugs. A U.S. network of clinical sites that tracked national prevalence rates of H. pylori, called the Helicobacter pylori Antimicrobial Resistance Monitoring Program, identified 347 clinical isolates of H. pylori to be analyzed for resistance to antibacterial drugs (Ref. 67). The researchers observed that 29.1 percent of isolates were resistant to one antibacterial drug and 4.8 percent of isolates were resistant to two or more antibacterial drugs. Other regions, such as China (Ref. 75) and Africa (Ref. 73), have reported even greater resistance rates to antibacterial drugs. Resistance to some classes of antibacterial drugs was associated with a reduction in treatment efficacy (Ref. 76). Eradication of H. pylori in humans is being challenged by the increasing rates of resistance to current treatment (Ref. 77). For the reasons described previously, FDA believes that H. pylori has the potential to pose a serious threat to public health, and FDA will add Helicobacter pylori to the list of qualifying pathogens.

One comment suggested adding Pandoraea species to the list of qualifying pathogens.

(Response) For the reasons that follow, FDA declines to add Pandoraea species to the list of qualifying pathogens.

The Pandoraea bacterial genus was identified in 2000; as of 2011, it contained five species (Ref. 78), all of which are aerobic gram-negative rods (Ref. 79). Historically, proper identification of these bacteria has been a challenge (id.), although a recent poster presentation at an international meeting suggested that Pandoraea species' production of carbapanem-cutting oxacillinase enzymes (which suggests that these bacteria may have intrinsic resistance to carbapanem antibiotics) may be a useful diagnostic tool (id.).

These bacteria are generally opportunistic and tend to colonize or infect patients with cystic fibrosis (CF) in particular (Ref. 78). However, both the prevalence and the pathogenic role of Pandoraea bacteria in patients with CF are unknown (Ref. 80). There have been reports of sporadic Pandoraea -related bacteremia and lung infections, including some in non-CF patients (Ref. 78). In addition, a 2003 report describes six CF patients who acquired Pandoraea species infections and four (out of the six) patients subsequently experienced a decline in lung function (Ref. 81).

Currently, there is too little information available about Pandoraea species to support their inclusion on the list of qualifying pathogens. Aside from a suggestion of intrinsic carbapanem resistance (Ref. 79), FDA is unaware of data suggesting increasing resistance—or any acquired resistance—to available therapies, or poorer outcomes with resistant strains of these pathogens. Further, “[t]he clinical significance of colonization with these organisms remains unclear, and there are limited and conflicting data available on the clinical outcome of patients colonized with Pandoraea” (Ref. 78). Thus, FDA declines to add Pandoraea species to the list of qualifying pathogens at the present time.

One comment suggested adding Peptostreptococcus species to the list of qualifying pathogens.

(Response) For the reasons that follow, FDA declines to add Peptostreptococcus species to the list of qualifying pathogens.

The Peptostreptococcus genus consist of anaerobic, gram-negative bacteria that are a part of the normal flora of human mucocutaneous surfaces, including the mouth, gastrointestinal track, female genitourinary system, urethra, and skin (Ref. 7 at p. 3121). The bacteria can cause a wide variety of infections, including respiratory, oropharyngeal, sinus, ear, musculoskeletal, intraabdominal, genitourinary, cardiovascular, dental, superficial, and soft tissue infections (Ref. 82). Infection typically is associated with trauma or disease (Ref. 83 at pp. 309-312) and has been identified to be a significant component of mixed infections (Ref. 82).

Notably, there is no evidence to show an increase in the rate of incidence or prevalence with Peptostreptococci (Ref. 84). Until recently, most clinical isolates of gram-positive anaerobic cocci were identified as a species of Peptostreptococcus, but this genus is currently being reclassified into three new genera: Micromonas, Anaerococcus, and Peptoniphilus (Ref. 85). Some species are also being transferred, for example, to the genus Streptococcus (Ref. 7 at p. 3121).

While resistance to antibacterial drugs is rare, resistance mechanisms have been identified as the transfer of plasmid-mediated mechanisms (Ref. 86 at p. 878). Peptostreptococci are usually fully susceptible to penicillin (Ref. 7 at p. 3122), though some isolates have occasionally been found to be resistant to penicillin (Ref. 85). Further, the genus has consistently reported no resistance to metronidazole, clindamycin, and imipenem (Ref. 84). Surveillance data from England and Wales do not support concerns regarding resistance to antibacterial therapies (Ref. 85).

There does not seem to be an emerging public health concern with infections caused by Peptostreptococci. Although resistance mechanisms have been identified, data on clinical pathogens are lacking and the rates of incidence or prevalence have not been shown to be increasing. Therefore, FDA will not be including Peptostreptococcus on the list of qualifying pathogens.

One comment suggested adding Scedosporium species to the list of qualifying pathogens because the fungal agent causes serious and life-threatening infections.

(Response) FDA notes that the comment appears to have conflated the standards for qualifying pathogens (“ pathogen[s] . . . that ha[ve] the potential to pose a serious threat to public health” (section 505E(f) of the FD&C Act)) and QIDPs (certain human “ drugs . . . intended to treat serious or life-threatening infections” (section 505E(g) of the FD&C Act)) (emphasis added). For the reasons that follow, FDA declines to add Scedosporium species to the list of qualifying pathogens.

Scedosporium comprises a family of fungi that is responsible for an increasing number of infections, particularly among immunocompromised patients (Ref. 87). Two species of Scedosporium are medically relevant: S. apiospermum and S. prolificans. These fungi are saprophytic agents with worldwide distribution that are isolated from natural sources (Ref. 88 at p. 4).

The fungi are typically acquired via direct inoculations, through a trauma wound or wound puncture (id.). Scedosporium infections are rare but can cause human infectious diseases, including soft tissue infections, septic arthritis, osteomyelitis, ophthalmic infections, sinusitis, pneumonia, meningitis and brain abscesses, endocarditis, and disseminated infection (Ref. 89). Disseminated infection has been observed with both species of Scedosporium (Ref. 88 at p. 4).

The overall incidence of Scedosporium infections is relatively low in most geographic areas of the United States. Hospital-based infections in patients with hematological malignancies have been observed (Ref. 87). Most disseminated S. prolificans infections are fatal due to persistent neutropenia and the intrinsic resistance to available antifungal agents (Ref. 90). Additionally, the management of invasive S. apiospermum infections is difficult because the pathogen has intrinsic resistance to many antifungal agents, including fluconazole and amphotericin (Ref. 91). A combination of chemotherapy and surgery seems to be the best approach in treating the infection (Ref. 88). Recovery from disseminated Scedosporium infections appears to result from improvement of the underlying disease (e.g., recovery from neutropenia) rather than from antifungal treatments (id.). Therefore, rate of growth of resistant organisms and an evaluation of rates of resistance would not provide meaningful evidence to support inclusion on the list of qualifying pathogens.

While Scedosporium is associated with high morbidity and mortality, the incidence of disease associated with Scedosporium is rare, and therefore there do not appear to be new public health concerns with these infections. For these reasons, FDA will not add Scedosporium to the list of qualifying pathogens.

One comment suggested adding Zygomycetes (specifically, Mucor, Rhizopus, Absidia, and Cunninghamella ) to the list of qualifying pathogens because these fungal agents cause serious and life-threatening infections.

(Response) FDA notes that the comment appears to have conflated the standards for qualifying pathogens (“ pathogen[s] . . . that ha[ve] the potential to pose a serious threat to public health” (section 505E(f) of the FD&C Act)) and QIDPs (certain human “ drugs . . . intended to treat serious or life-threatening infections” (section 505E(g) of the FD&C Act)) (emphasis added). For the reasons that follow, FDA declines to add Zygomycetes to the list of qualifying pathogens.

The class of Zygomycetes is a large group of fungi that are mostly opportunistic pathogens responsible for infections in high-risk patients, such as immunocompromised and type 2 diabetes mellitus patients (Ref. 92). There are two orders of Zygomycetes of medical interest: the Mucorales, which cause the majority of illness, and the Entomophthorales (Ref. 93 at p. 236). The main categories of human disease associated with Mucorales are sinusitis/rhinocerebral, pulmonary, cutaneous/subcutaneous, gastrointestinal, and disseminated zygomycosis (Ref. 93 at p. 244).

The host generally acquires the infectious spores through inhalation, ingestion, or inoculation through breaches in or penetrating injuries to the skin (Ref. 92). Host risk factors include diabetes mellitus, neutropenia, sustained immunosuppressive therapy, broad-spectrum antibiotic use, severe malnutrition, and primary breakdown in the integrity of the cutaneous barrier such as trauma, surgical wounds, needle sticks, or burn wounds (id.). Zygomycosis occurs rarely in non-immunocompromised hosts.

Zygomycetes are relatively uncommon isolates in the clinical laboratory and are less frequent than invasive fungi caused by Aspergillus species. According to one report, “[i]ncidence figures are difficult to collect as few national studies have been undertaken, but for the United States, the annual incidence of zygomycosis has been estimated as 1.7 infections per million people” (Refs. 92 and 94). According to a 2002 report, the incidence of zygomycosis may be increasing; researchers found an increase in the number of hematopoietic stem cell transplant recipients at the Fred Hutchinson Cancer Center in Seattle, WA, infected with Zygomycetes from 1985-1989 to 1995-1999 (Ref. 95). Another study found that invasive fungal infections due to Zygomycetes were associated with higher mortality rates in adult hematopoietic stem cell transplant recipients at 64.3 percent, with suboptimal therapeutic modalities for the management of the infection as one contributing factor to the high rates (Ref. 96).

Surgical debridement should be considered as an option early in management of zygomycosis as the evidence indicates that this intervention improves survival (Ref. 92). Additionally, the agent of choice was conventional amphotericin B used at higher than normal doses (id.). FDA's research did not identify any papers that suggest an increase in the resistance rates to antifungal treatment.

Zygomycetes are associated with high morbidity and mortality rates. However, there do not appear to be new or changing public health concerns with infections caused by Zygomycetes. Further, resistance data on clinical pathogens are lacking. Therefore, FDA will not add Zygomycetes to the list of qualifying pathogens.

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule would not impose direct costs on any entity, regardless of size, but rather would clarify certain types of pathogens for which the development of approved treatments might result in the awarding of QIDP designation and exclusivity to sponsoring firms, FDA certifies that the rule would not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

Antibacterial research and development has reportedly declined in recent years. A decrease in the number of new antibacterial products reaching the market in recent years has led to concerns that the current drug pipeline for antibacterial drugs may not be adequate to address the growing public health needs arising from the increase in antibacterial or antifungal resistance. A number of reasons have been cited as barriers to robust antibacterial drug development including smaller profits for short-course administration of antibacterial drugs compared with long-term use drugs to treat chronic illnesses, challenges in conducting informative clinical trials demonstrating efficacy in treating bacterial infections, and growing pressure to develop appropriate limits on antibacterial drug use.

One mechanism that has been used to encourage the development of new drugs is exclusivity provisions that provide for a defined period during which an approved drug is protected from submission or approval of certain potential competitor applications. By securing additional guaranteed periods of exclusive marketing, during which a drug sponsor would be expected to benefit from associated higher profits, drugs that might not otherwise be developed due to unfavorable economic factors may become commercially attractive to drug developers.

In recognition of the need to stimulate investments in new antibacterial or antifungal drugs, Congress enacted the GAIN title of FDASIA to create an incentive system. The primary framework for encouraging antibacterial or antifungal drug development became effective on July 9, 2012, through a self-implementing provision that authorizes FDA to designate human antibacterial or antifungal drugs that treat “serious or life-threatening infections” as QIDPs. With certain limitations set forth in the statute, a sponsor of an application for an antibacterial or antifungal drug that receives a QIDP designation gains an additional 5 years of exclusivity to be added to certain exclusivity periods for that product. Drugs that receive a QIDP designation are also eligible for designation as a fast-track product and an application for such a drug is eligible for priority review.

Between July 9, 2012, when the GAIN title of FDASIA went into effect, and March 12, 2014, FDA granted 41 QIDP designations. As explained above, the statutory provision that authorizes FDA to designate certain drugs as QIDPs is self-implementing, and inclusion of a pathogen on the list of “qualifying pathogens” does not determine whether a drug proposed to treat an infection caused by that pathogen will be given QIDP designation. However, section 505E(f) of the FD&C Act, added by the GAIN title of FDASIA, requires that FDA establish a list of “qualifying pathogens.” This final rule is intended to satisfy that obligation, as well as the statute's directive to make public the methodology for developing such a list of “qualifying pathogens.” The final rule identifies 21 “qualifying pathogens,” including those provided as examples in the statute, which FDA has concluded have “the potential to pose a serious threat to public health” and proposes to include on the list of “qualifying pathogens.”

As previously stated, this final rule would not change the criteria or process for awarding QIDP designation or for awarding extensions of exclusivity periods. That is, the development of a treatment for an infection caused by a pathogen included on the list of “qualifying pathogens” is neither a necessary nor a sufficient condition for obtaining QIDP designation, and as stated in section 505E(c) of the FD&C Act, not all applications for a QIDP are eligible for an extension of exclusivity. Relative to the baseline in which the exclusivity program under GAIN is in effect, we anticipate that the incremental effect of this rule would be negligible.

To the extent that this rule causes research and development to shift toward treatments for infections caused by pathogens on the list and away from treatments for infections caused by other pathogens, the opportunity costs of this rule would include the forgone net benefits of products that treat or prevent pathogens not included on the list, while recipients of products to treat infections caused by pathogens on the list would receive benefits in the form of reduced morbidity and premature mortality. Sponsoring firms would experience both the cost of product development and the economic benefit of an extension of exclusivity and of potentially accelerating the drug development and review process with fast-track status and priority review. If this rule induces greater interest in seeking QIDP designation than would otherwise occur, FDA also would incur additional costs of reviewing applications for newly developed antibacterial or antifungal drug products under a more expedited schedule.

Given that the methodology for including a pathogen on the list of “qualifying pathogens” was developed with broad input, including input from industry stakeholders and the scientific and medical community involved in anti-infective research, we expect that the pathogens listed in this final rule reflect not only current thinking regarding the types of pathogens that have the potential to pose serious threat to the public health, but also current thinking regarding the types of pathogens that cause infections for which treatments might be eligible for QIDP designation. To the extent that there is overlap between drugs designated as QIDPs and drugs developed to treat serious or life-threatening infections caused by pathogens listed in this final rule, this final rule would have a minimal impact in terms of influencing the volume or composition of applications seeking QIDP designation compared to what would otherwise occur in the absence of this rule.

FDA concludes that this rule does not contain a “collection of information” that is subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). This rule interprets some of the terms used in section 505E of the FD&C Act and proposes “qualifying pathogen” candidates. Inclusion of a pathogen on the list of “qualifying pathogens” does not confer any information collection requirement upon any party, particularly because inclusion of a pathogen on the list of “qualifying pathogens” and the QIDP designation process are distinct processes with differing standards.

The QIDP designation process will be addressed separately by the Agency at a later date. Accordingly, the Agency will analyze any collection of information or additional PRA-related burdens associated with the QIDP designation process separately.

FDA has analyzed this rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency concludes that this rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m. Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .)

Section 816 of the Violence Against Women and Department of Justice Reauthorization Act of 2005, Title VIII of Public Law 109-162, codified at 8 U.S.C. 1154(a)(1)(A)(vii), created an immigrant visa classification for the parents of U.S. citizens, and the parents of former U.S. citizens who, within the past two years, have lost or renounced U.S. citizenship status related to an incident of domestic violence or died.

The Department currently identifies applicants for this status using the “IB5” symbol, an existing symbol used for parents of U.S. citizens who are at least 21 years old. The unique IB5 classification symbol will facilitate the Department's ability to identify applicants for such status in various immigrant visa information databases.

Since this rule concerns the administration of visas, which is a foreign affairs function of the United States, the Department publishes this rule as a final rule pursuant to 5 U.S.C. 553(a)(1). In addition, since this rule implements the provisions of the Violence Against Women and Department of Justice Reauthorization Act of 2005, the Department finds that notice and public comment on this rule are unnecessary, pursuant to 5 U.S.C. 553(b)(B). Accordingly, this rule is effective immediately.

Because this rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth at sections 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department has reviewed this regulation and certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 104-4, 109 Stat. 48, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments.

This rule is not a major rule as defined by 5 U.S.C. 804, for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. This rule would not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Department does not consider this rule to be a “significant regulatory action” within the scope of section 3(f) of Executive Order 12866. Nonetheless, the Department has reviewed the rule to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Order.

The Department of State has considered this rule in light of Executive Order 13563 and affirms that this regulation is consistent with the guidance therein.

This regulation will not have substantial direct effects on the states, on the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government. Nor will the rule have federalism implications warranting the application of Executive Orders 12372 and 13132.

The Department has reviewed the regulations in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

This rule does not impose information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C., Chapter 35.

22 CFR Part 42 is amended as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.”

Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not using the NPRM process. The Coast Guard received notice on March 27, 2014 that this display would take place. After full review of the event information and location, the Coast Guard determined that a safety zone is necessary. Delaying this rule by completing the full NPRM process would unnecessarily delay the safety zone and be contrary to public interest because the safety zone is needed to protect transiting vessels, spectators, and the personnel involved in the display from the hazards associated with fireworks displays taking place near and over the waterway. The fireworks display has been advertised and the local community has prepared for the event. Completing the full NPRM process could also unnecessarily delay the planned event and possibly interfere with contractual obligations.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying this rule by providing a full 30 days notice would be contrary to public interest because immediate action is needed to protect persons and property in the area during the land-based fireworks display.

On June 13, 2014, as a part of the Rices Landing Riverfest Fireworks Display, the Rices Landing Volunteer Fire Department will sponsor a land-based fireworks display. The display will take place in the vicinity of Old Lock 6 at mile 68.3 the Monongahela River. This event presents safety hazards for spectators and vessels navigating in the area, and therefore a safety zone is needed to protect persons and property from the hazards associated with a fireworks display near and over the waterway.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

The Coast Guard is establishing a safety zone for all waters of the Monongahela River, from mile 68.0 to mile 68.8, extending the entire width of the river. Entry into this zone is prohibited to all vessels and persons except persons and vessels specifically authorized by the Captain of the Port Pittsburgh. This rule is effective on June 13, 2014 and will be enforced from 9:15 p.m. until 10:30 p.m.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). This rule is limited in scope and will be in effect for a limited time period and notifications will be made to the marine community by contacting local industry contacts that could be operating in the area during the event. Deviation from the rule may be requested and will be considered on a case-by-case basis by the Captain of the Port or a designated representative. The impacts on routine navigation are expected to be minimal.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the Monongahela River, mile 68.0 to 68.8 from 9:15 p.m. until 10:30 p.m. on June 13, 2014. This safety zone will not have a significant economic impact on a substantial number of small entities because this rule is limited in scope and will be in effect for a limited time period and notifications to the marine community will be made by contacting local industry contacts that could be operating in the area during the event. Deviation from the rule may be requested and will be considered on a case-by-case basis by the Captain of the Port or a designated representative.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT , section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination With Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a safety zone for waters of the Monongahela River, from mile 68.0 to 68.8. This rule is categorically excluded from further review under paragraph 34(g) of figure 2-1 of the Commandant Instruction an environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.”

Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not using the NPRM process. The Coast Guard received notice on March 27, 2014 that this display would take place. After full review of the event information and location, the Coast Guard determined that a safety zone is necessary. Delaying this rule by completing the full NPRM process would unnecessarily delay the safety zone and be contrary to public interest because the safety zone is needed to protect transiting vessels, spectators, and the personnel involved in the display from the hazards associated with fireworks displays taking place over the waterway. The fireworks display has been advertised and the local community has prepared for the event. Completing the full NPRM process could also unnecessarily delay the planned event and possibly interfere with contractual obligations.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying this rule by providing a full 30 days notice would be contrary to public interest because immediate action is needed to protect persons and property in the area during the barge-based fireworks display.

On June 13, 2014, as a part of the Movie in the Park, Downtown Kittanning, Inc. will sponsor a barge-based fireworks display. The display will take place in the vicinity of mile 44.5 on the Allegheny River. This event presents safety hazards for spectators and vessels navigating in the area, and therefore a safety zone is needed to protect persons and property from the hazards associated with a fireworks display over the waterway.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

The Coast Guard is establishing a safety zone for all waters of the Allegheny River, from mile 44.0 to mile 45.0, extending the entire width of the river. Entry into this zone is prohibited to all vessels and persons except persons and vessels specifically authorized by the Captain of the Port Pittsburgh. This rule is effective on June 13, 2014 and will be enforced from 8:00 p.m. until 11:00 p.m.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). This rule is limited in scope and will be in effect for a limited time period and notifications to the marine community by contacting local industry contacts that could be operating in the area during the event. Deviation from the rule may be requested and will be considered on a case-by-case basis by the Captain of the Port or a designated representative. The impacts on routine navigation are expected to be minimal.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the Allegheny River, mile 44.0 to 45.0 from 8:00 p.m. until 11:00 p.m. on June 13, 2014. This safety zone will not have a significant economic impact on a substantial number of small entities because this rule is limited in scope and will be in effect for a limited time period and notifications to the marine community will be contacting local industry contacts that could be operating in the area during the event. Deviation from the rule may be requested and will be considered on a case-by-case basis by the Captain of the Port or a designated representative.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT , section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination With Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a safety zone for waters of the Allegheny River, from mile 44.0 to 45.0. This rule is categorically excluded from further review under paragraph 34(g) of figure 2-1 of the Commandant Instruction an environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the safety zone listed in 33 CFR 165.935, Safety Zone, Milwaukee Harbor, Milwaukee, WI, at the following times for the following events:

(1) Pridefest fireworks display on June 7, 2014, from 9:15 p.m. until 10:15 p.m.;

(2) Polish Fest fireworks display on June 14, 2014, from 10:15 p.m. until 11:15 p.m.;

(3) Summerfest fireworks display on June 25, 2014, and July 2, 2014 from 9:15 p.m. until 10:30 p.m.;

(4) Festa Italiana fireworks display on each day of July 18, 19, and 20, 2014, from 10:15 p.m. until 11:15 p.m.;

(5) Arab World Festival fireworks display on August 9, 2014, from 9:15 p.m. until 10:15 p.m.;

(6) German Fest fireworks display on July 25, 2014, from 10:15 p.m. until 11:15 p.m.;

(7) Irish Fest fireworks display on August 17, 2014, from 10:15 p.m. until 11:15 p.m.;

(8) Indian Summer fireworks display on September 6, 2014, from 9:45 p.m. until 10:45 p.m.

This safety zone will encompass the waters of Lake Michigan within Milwaukee Harbor including the Harbor Island Lagoon enclosed by a line connecting the following points: beginning at 43°02′00″ N, 087°53′53″ W; then south to 43°01′44″ N, 087°53′53″ W; then east to 43°01′44″ N, 087°53′25″ W; then north to 43°02′00″ N, 087°53′25″ W; then west to the point of origin. All vessels must obtain permission from the Captain of the Port, Lake Michigan, or his or her on-scene representative to enter, move within, or exit the safety zone. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the Captain of the Port, Lake Michigan, or his or her on-scene representative. This document is issued under authority of 33 CFR 165.935 Safety Zone, Milwaukee Harbor, Milwaukee, WI and 5 U.S.C. 552(a). In addition to this document in the Federal Register , the Coast Guard will provide the maritime community with advance notification of the enforcement period via broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port, Lake Michigan, or his or her on-scene representative may be contacted via VHF Channel 16.

The Coast Guard will enforce a safety zone in navigable waters around and under the fireworks barge within a radius of 100 feet during the loading, transit, and arrival of the fireworks barge to the display location and until the start of the fireworks display. From 7 a.m. until 9 a.m. on July 3, 2014, the fireworks barge will be loading pyrotechnics off of Tahoe Keys Marina in South Lake Tahoe, CA in approximate position 38°56′05″ N, 120°00′09″ W (NAD 83). From 9 a.m. to 11 a.m. on July 3, 2014, the loaded fireworks barge will transit from Tahoe Keys Marina to the launch site off of Kings Beach, CA in approximate position 39°13′55″ N, 120°01′42″ W (NAD 83) where it will remain until the commencement of the fireworks display. Upon the commencement of the 30 minute fireworks display, scheduled to begin at 9:30 p.m. on July 3, 2014, the safety zone will increase in size to encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet in approximate position 39°13′55″ N, 120°01′42″ W (NAD 83) for the Independence Day Fireworks, Kings beach, CA in 33 CFR 165.1191, Table 1, Item number 17. This safety zone will be in effect from 7 a.m. until 10 p.m. on July 3, 2014.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552 (a). In addition to this notice in the Federal Register , the Coast Guard will provide the maritime community with extensive advance notification of the safety zone and its enforcement period via the Local Notice to Mariners. If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities. The program is also intended to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

The purpose of the RERCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDRR with guidance from its Rehabilitation Research Advisory Council. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers, and other research stakeholders. Additional information on the RERC program can be found at: http://www2.ed.gov/programs/rerc/index.html#types.

Applicable Program Regulations: 34 CFR part 350.

We published a notice of proposed priority for this program in the Federal Register on April 2, 2014 (79 FR 18490). That notice contained background information and our reasons for proposing the particular priority.

There are no differences between the proposed priority and this final priority.

Public Comment: In response to our invitation in the notice of proposed priority we did not receive any comments on the proposed priority.

The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority for a RERC on Technologies to Enhance Independence in Daily Living for Adults with Cognitive Impairments.

The RERC must focus on innovative technological solutions, new knowledge, and implementation strategies that enhance the independence and self-management of adults with cognitive impairment.

Under this priority, the RERC must research, develop, and evaluate new technologies, or adapt and evaluate existing technologies, to enhance the ability of adults with cognitive impairment to perform daily activities of their choice in the home, community, or workplace. Technologies developed or adapted must be designed for commercialization as consumer products or for integration into rehabilitation practice or relevant service delivery systems. Research and development topics under this priority may include, but are not limited to: Monitoring and prompting technologies or other information or communication aids; assistive technologies, including socially assistive robotics; mobile and wearable technologies; virtual reality; and care coordination or tele-health, tele-rehabilitation, and other tele-support systems to facilitate improved activities of daily living.

In responding to this priority, applicants must specify the target populations or subgroups of adults with cognitive impairments that they intend to focus on and identify the setting or settings for which they intend to develop technologies: Home, community, or workplace. Applicants must also limit the number of research and development projects to a maximum of eight, and restrict the range of different types of technologies to what is manageable with available resources.

Under this priority, the RERC must be designed to contribute to the following outcomes:

(a) Increased technical and scientific knowledge relevant to technologies for increasing independence in daily living for adults with cognitive impairments. The RERC must contribute to this outcome by establishing a rigorous research and development plan that is balanced between technology development or adaption and technology evaluation and incorporates needs assessment, usability testing, and intervention development or efficacy studies, as appropriate. The research and development plan must be designed to build a base of evidence for assessing the usability, accessibility, acceptance, utility, and cost-benefit of technologies intended to improve independence in daily activities for adults with cognitive impairment in the home, community, or workplace settings. The RERC must contribute to this outcome by:

(i) Building a transdisciplinary team of collaborators from relevant disciplines, such as: Rehabilitation and bio-engineering, computer science, human factors specialists, cognitive and behavioral scientists, clinicians, and other relevant providers;

(ii) Conducting research and research syntheses or secondary analysis of existing data to evaluate user needs and specify the accessibility, acceptance, and human factors design features that will need to be built into the technology solutions developed and evaluated by the RERC to accommodate the cognitive impairments and preferences of the target population;

(iii) Conducting rigorous usability testing in the settings in which the technology will be used;

(iv) Developing and prioritizing a list of evaluation topics that, when addressed, will lead to research-based information on the utility or efficacy of technology solutions developed by the RERC; and

(v) Involving key stakeholders in the research and research planning activities to maximize the relevance and usefulness of the research products being developed. Stakeholders can include, but are not limited to, individuals with disabilities and their families; national, State, or local-level policymakers, administrators, or service providers; and industry representatives.

(b) Improved usability and effectiveness of technologies, products, devices, systems, performance guidelines, and assessment tools through systematic development or adaptation, testing, and evaluation of innovations. In developing the technologies under this priority the RERC must:

(i) Incorporate user-centered design strategies and consider the context in which the technology product, device, or system will be used;

(ii) Emphasize the principles of universal design and, as appropriate, conform to human factors standards, such as reliability, safety, and simplicity; accessibility and acceptability to users; protective of users' privacy preferences; intuitive user interfaces; feedback in meaningful sensory modalities; and appropriateness to diverse populations;

(iii) Incorporate ongoing training opportunities or user supports into the design of the technology or into the practice settings or delivery systems in which the technology will be integrated; and

(iv) Ensure that the technologies are interoperable within existing rehabilitation systems or home or mobile technologies and that they communicate with existing information technology systems, as appropriate.

(c) Improved research capacity areas that will contribute to enhancing the ability of adults with cognitive impairment to perform daily activities. The RERC must contribute to this outcome by collaborating with the relevant institutions of higher education, professional associations, clinicians and service providers, and other researchers or educators, as appropriate.

(d) Improved awareness and understanding of cutting-edge developments and promising technology solutions that will contribute to enhancing the ability of adults with cognitive impairment to perform daily activities. The RERC must contribute to this outcome by identifying and communicating with relevant stakeholders, including NIDRR, individuals with disabilities and their representatives, disability organizations, service providers, professional journals, manufacturers, and other interested parties regarding trends and evolving product concepts related to its designated priority research area.

(e) Increased impact of research and development activities carried out under this priority area. The RERC must contribute to this outcome by:

(i) Providing technical assistance to relevant public and private organizations, individuals with disabilities and their families, long-term services and supports providers, and employers on policies, guidelines, and standards; and

(ii) Establishing or contributing to an existing program or service that provides objective information and technical and consumer reviews about technologies of promise to support independence in daily living for adults with cognitive impairments.

(f) Increased transfer of RERC-developed technologies to the marketplace for widespread testing and use by developing and implementing a plan to ensure that technologies developed by the RERC are made available to the public or to service delivery systems that serve the public. This technology transfer plan must be developed in the first year of the project period in consultation with the NIDRR-funded Center on Knowledge Translation for Technology Transfer.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing this final priority only on a reasoned determination that its benefits justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years, as projects similar to the one envisioned by the final priority have been completed successfully. The new RERC would generate, disseminate, and promote the use of new information that is intended to improve outcomes for individuals with disabilities in the areas of community living and participation, employment, and health and function.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

The Postal Service hereby gives notice that the enforcement date of January 25, 2015, for eliminating mailers' option to use Business Reply Mail (BRM) to pay postage for parcel-shaped items, previously published on December 18, 2013, in a final rule in the Federal Register (78 FR 76548-76560), is hereby deferred until further notice. In particular, this deferral applies to the requirements specified in the amendment to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®) 505.1.4.1 (Business Reply Mail—General Information—Description) published at 78 FR 76560. The decision to defer the enforcement date of this change was based on the review of subsequent mailer feedback. All other requirements that were published in the Federal Register (78 FR 76548-76560) will be implemented as specified.

Despite the decision to defer the above referenced enforcement date, the Postal Service continues to believe that mailers who currently distribute BRM cartons and labels for the return of parcel-shaped items would be better served by switching to Merchandise Return Service® In light of mailers' continuing eligibility to use BRM for the payment of postage for parcel-shaped items, and the Postal Service's goal of promoting enhanced package visibility, the Postal Service expects to propose rules mandating the use of an Intelligent Mail® package barcode on certain BRM cartons and labels.

The site to be deleted from the NPL is: Harbor Oil Superfund Site located at 11535 North Force Avenue in Portland, Oregon. A Notice of Intent to Delete for this Site was published in the Federal Register (79 FR 19037-19039) on April 7, 2014.

The closing date for comments on the Notice of Intent to Delete was May 16, 2014. No public comments were received. Since there were no comments, EPA is finalizing the deletion of the Site from the NPL. No responsiveness was prepared.

EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.

For reasons set out in the preamble, 40 CFR part 300 is amended as follows:

On December 2, 2013 (78 FR 72146), FMCSA encouraged interested parties to submit comments and related materials to docket number FMCSA-2013-0457.

To view comments, as well as documents mentioned in this document as being available in the docket, go to http://www.regulations.gov and insert the docket number, “FMCSA-2013-0457” in the “Keyword” box and click “Search.” Next, click “Open Docket Folder” button and choose the document listed to review. If you do not have access to the Internet, you may view the docket by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. Monday through Friday, except Federal holidays.

All comments the Agency received were posted without change to http://www.regulations.gov and include any personal information provided. Anyone may search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or of the person signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Complete, timely, accurate, and consistently-reported inspection data enables FMCSA to achieve its safety mission by identifying and addressing trends in regulatory compliance. States adopt and enforce Federal standards for motor carrier safety and hazardous materials transportation under State law as an eligibility requirement for receipt of grant funds under the Motor Carrier Safety Assistance Program (MCSAP). MCSAP also requires that States report violations discovered through roadside inspections to FMCSA data systems and that they participate in FMCSA's national data correction system known as DataQs.

In addition to the inspection data reported to FMCSA, States may issue a citation associated with a violation noted in the roadside inspection. Such citations may subsequently be adjudicated in a due process system. The change reflected in this document and in FMCSA's data systems will allow motor carriers or drivers to submit the results of an adjudicated citation through the DataQs system. After confirming the adequacy of the documentation submitted in an RDR, the State will submit the adjudication results into the new field created to record this information.

Adjudication results recorded in MCMIS will potentially impact other FMCSA data systems, such as the Agency's Safety Measurement System (SMS) and the Pre-employment Screening Program (PSP).

Based on feedback to the December 2, 2013, notice, the Agency has determined that it will not apply this policy retroactively. The policy announced in this document applies to inspections occurring on or after August 23, 2014. Accordingly DataQs will be modified to accept RDRs related to adjudicated citations in August 2014. The August 23, 2014, date is based on the time needed for State implementation of compatible State information technology (IT) systems able to record and transmit the adjudication data.

This document announces changes to MCMIS that support a more consistent program for handling DataQs seeking recognition of adjudicated citations. This document contains a general statement of policy and reflects a change in Agency practice and procedures with respect to the handling of adjudicated citations through DataQs and in Agency information systems. The Administrative Procedure Act (APA), 5 U.S.C. 552(a)(1)(D), requires agencies to provide public notice of statements of general policy by publication in the Federal Register . Such “interpretative rules, general statements of policy or rules of agency organization, procedure, or practice” are not subject to the APA's notice and comment requirements (5 U.S.C. 553(b)(A)). This document does not amend any Agency regulation nor does it change how data correction is sought through DataQs. The IT and program changes announced in this document allow FMCSA and the States to receive more complete information on the subsequent disposition of citations issued during roadside inspections by accepting certified records of adjudication results submitted through the DataQs process.

Presently, MCMIS contains records of inspections, including violations observed by law enforcement officers, during such commercial motor vehicle (CMV) inspections. See 78 FR 59082, 59083 (September 25, 2013). Because MCMIS has always been a system that records roadside inspection data, MCMIS records presently do not reflect convictions, acquittals or other subsequent adjudications or adjustments of charges that occur during subsequent due process proceedings. A driver has always been able to challenge the correctness of a violation that has been cited in a roadside inspection report using the DataQs system, whether a citation has been issued for that violation or not.

As currently required in the MCSAP grant program, pursuant to 49 CFR 350.201(s), the States must “establish a program to ensure that accurate, complete, and timely motor carrier safety data are collected and reported, and ensure the State's participation in a national motor carrier safety data correction system prescribed by FMCSA.” Today's announced policy change is thus within the scope of the current MCSAP program.

State and local law enforcement officials routinely conduct roadside inspections documenting violations of laws or regulations that are compatible with the Federal Motor Carrier Safety Regulations (FMCSRs) and Hazardous Materials Regulations (HMRs). See 49 CFR 350.105 (defining “compatible or “compatibility”). These law enforcement officials, at their discretion, may issue citations for the violations recorded on the roadside inspection report. States are responsible for entering roadside inspection and violation data into SafetyNet, a database management system that allows entry, access, analysis, and reporting of data from driver/vehicle inspections, crashes, investigations, assignments, and complaints. SafetyNet provides data to MCMIS that interfaces with several databases, including: (1) The Safety and Fitness Electronic Records (SAFER) system; (2) PSP; and (3) SMS. SafetyNet and MCMIS have always contained records of inspections and reportable crashes.

As noted, pursuant to 49 CFR 350.201(s), one condition for participation in the Motor Carrier Safety Assistance Program (MCSAP) is that a State establish a program to ensure that accurate and timely motor carrier safety data are collected and reported and that the State participates in a national motor carrier safety data correction system prescribed by FMCSA. DataQs is that national motor carrier data correction system (49 CFR 350.211) (State certification at paragraph 11). DataQs is an online system that provides an electronic means for drivers, motor carriers, and members of the public to submit concerns about the accuracy of crash, inspection, and violation data in FMCSA data systems. When a request for an RDR is filed, the DataQs system automatically forwards the request to the appropriate Federal or State office for processing and resolution ( https://dataqs.fmcsa.dot.gov/ ).

The data system and policy changes announced in this document will allow drivers, motor carriers, and members of the public to file an RDR in FMCSA's DataQs system and to seek acknowledgement of the adjudication in the inspection record. The change in the State data systems will parallel corresponding changes to FMCSA data systems. A citation that has been resolved through a judicial or administrative process, regardless of outcome, is considered to be adjudicated.

FMCSA believes these changes will (1) provide a uniform and orderly process to incorporate recording adjudicated citations through DataQs under the State's MCSAP Commercial Vehicle Safety Plans and budgets (see 49 CFR 350.213 for description of CVSP); (2) provide an effective process to ensure system effectiveness and data quality; and (3) reduce the cost of applying and implementing these changes across the Agency and the States. FMCSA is requiring that MCSAP grantees follow this policy of recording adjudication results as a condition of their grant funding under 49 CFR 350.201.

FMCSA announced proposed changes to MCMIS on December 2, 2013 (78 FR 72146). The Agency received 111 unique comments during the 30-day comment period. Seventy of the 111 comments supported the proposed changes, with commenters stating that this change will help ensure that drivers and carriers are treated justly. Steve Davis, a fleet owner for FedEx Ground, said, “I strongly approve of this change to allow updated court information to be included in MCMIS. This will improve uniformity without question and give a true account of the resolution of violation information.” More than half of the supporting commenters (38) did not identify themselves with a specific stakeholder group. The remaining commenters in support of the changes were motor carriers (17) and representatives of industry associations (9) and the Commercial Motor Vehicle Safety Alliance (CVSA).

The motor carriers that commented included Coach USA, DART Transit Company, J.B. Hunt, Sharp Transport, Inc., and Stallion Transportation Group. The industry associations that submitted comments included the Alliance for Safe, Efficient and Competitive Trucking Transportation (ASECTT), American Bus Association (ABA), American Moving and Storage Association (AMSA), American Trucking Associations, Inc. (ATA), Institute of Makers of Explosives (IME), International Food Distributors Association (IFDA), Minnesota Trucking Association/Minnesota Trucking Associate Safety Council (MTA/MTASC), National Association of Small Trucking Companies (NASTC), Owner-Operator Independent Drivers Association, Inc. (OOIDA).

Those commenters generally opposing the changes offered suggestions to improve the proposal. These included Advocates for Highway and Auto Safety (Advocates), American Association for Justice (AAJ), the Kentucky State Police, the Pennsylvania State Police, and the West Virginia Public Service Commission. One commenter, Jeff Steeger, who did not identify himself with a particular group, objected to the policy and stated it would “allow carriers and their drivers to improve their SMS score while demonstrating a continued lack of compliance with our safety regulations.”

The common areas of concern included enforcement impacts; pleas, dismissals, and other court actions; retroactive implementation; workload and resources; continued uniformity concerns; and questions about the impacts on SMS weighting based on violation on the conviction.

Comments to the docket also addressed consistency in the processing of RDRs, other quality assurance initiatives, crash weighting and the process for requesting appeals. Most of these issues are outside of the scope of the December 2, 2013, notice and, therefore, are not addressed herein. It should be noted, however, that the Agency is involved in separate initiatives addressing many of these issues.

FMCSA received comments seeking clarification on what is a “conviction” under FMCSA regulations and expressing concerns that routinely-assessed fees may inadvertently count as “convictions.” In Section V.A. of today's document the Agency clarifies how it interprets the regulatory definitions in 49 CFR 383.5 and 390.5.

Both law enforcement and industry commenters expressed concerns that changing how data systems address violations in roadside inspections based on adjudicated citations would result in law enforcement officers issuing fewer citations. The impact of this change would be that officers would issue more warnings, which cannot be adjudicated by a court. Four commenters affiliated with law enforcement agencies indicated that this change would result in an influx of RDRs and increased workload. Coach USA urged that, “FMCSA should not accept information regarding violations from state officials unless the state issued a citation for the alleged violation at issue.”

FMCSA acknowledges that law enforcement agencies may alter their enforcement practices as a result of today's policy change. However, it remains the Agency's position that these process changes will improve data quality, accuracy, and uniformity. The Agency's interests are in capturing fair and accurate violations in MCMIS. FMCSA has never provided direction to law enforcement on when to issue citations and defers to those agencies for the best ways to enforce the violations they observe.

The treatment of dismissed citations was the most common topic addressed by commenters. Sixteen commenters argued that a dismissed citation does not always indicate that the violation did not occur at the time of the inspection and, therefore, dismissed citations should not be the sole basis for removing violations from inspection reports. These commenters expressed the opinion that often citations are dismissed based on plea bargaining or technical issues such as the carrier's or driver's evidence of corrective action, a lenient judge or jury, an absent officer-witness, or a clerical error.

Several commenters expressed concern that there will be increased attempts to plea bargain to a violation with a lower severity weight to improve SMS scores. Additionally, commenters expressed concern about court clerks causing errors or officers being unable to attend hearings, resulting in dismissals. Lt. Colonel Keith Percy of the Kentucky State Police, stated that “Criminal court systems, already overburdened with cases considered more serious than traffic violations, are under great pressure to deal cases away, and traffic cases fall away with little, if any, political consequence.”

Advocates for Highway and Auto Safety recommended that “the agency should maintain discretion to retain citations, even when dismissed, if such dismissals are not on the merits and indicate a pattern and practice that would violate the prohibition against masking of traffic violations.”

FMCSA acknowledges that these scenarios may occur. However, there are checks and balances in place to prevent improper dismissal of commercial driver violations, including 49 CFR 384.226 that prohibits States from masking convictions, deferring imposition of judgment, or allowing an individual to enter into a diversion program that would prevent a commercial learner's permit (CLP) or CDL holder's conviction from appearing on the Commercial Driver's License Information System (CDLIS) driving record.

On the issue of burden on the system, it should be noted that, notwithstanding the nearly 3.5 million inspections conducted from January 1, 2013, through December 31, 2013, there were fewer than 40,000 RDRs submitted through DataQs for this period.

Based on an annual estimate of 3.5 million inspections, only 1.1 percent of inspections resulted in an RDR. The Agency has confidence that the courts will strive to objectively evaluate the charged violations and that dismissals of citations for administrative or other reasons will not have a significant impact on the reliability of safety data. Additionally, the Agency will continue to provide outreach to courts and prosecutors to explain the serious impacts of cases involving CMVs and commercial drivers and to improve their knowledge and understanding of CMV violations and their potential consequences.

As part of its data quality program, FMCSA will be monitoring the incoming data on adjudicated citations to look for patterns that might indicate routine masking of violations by State officials and take appropriate action to address these situations.

The December 2, 2013, notice specifically asked for comment on the Agency's plan to implement these changes prospectively. Only six commenters addressed the issue. Three representatives of industry associations recommended that the Agency apply the policy retroactively, starting from the implementation of the Compliance, Safety, Accountability program in 2010. Two members of the law enforcement community supported the prospective-only application of the policy. Stephen Keppler of the Commercial Vehicle Safety Alliance noted that applying the policy retroactively would have significant adverse impacts, including decreased data uniformity and consistency, and an increase in States' workloads that could deplete their resources. Mr. Keppler also stated that prospective implementation of this policy “allows for improved planning, resource allocation and management for both the States and FMCSA.”

The Kentucky State Police indicated that they would expect the number of RDRs submitted to increase significantly, especially due to dismissals. The Pennsylvania State Police noted that there would be significant workload impact on the minor judiciary. The Agency therefore continued to consider workload in deciding not to implement this change retroactively.

FMCSA continues to believe that prospective application will mitigate the potential for significantly increased numbers of RDRs, based on hundreds—potentially thousands—of past adjudicated citations, which could quickly exhaust States' DataQs capability. Such a drain on State DataQs staff could prevent States from promptly acting on other RDR requests and/or could create a need to redirect scarce State resources, adversely affecting motor carrier safety enforcement. As previously stated, FMCSA believes that prospective application will (1) provide a uniform and orderly process for the States to incorporate this policy into their State MCSAP plans and budgets (see 49 CFR 350.213); (2) provide an effective process that the Agency can test to ensure system effectiveness and data quality; and (3) reduce the cost of applying and implementing these changes across the Agency and the States.

Based on the comments and the workload and safety impacts noted above, the Agency has determined that it will implement the policy and changes prospectively. The policy announced in this document applies to inspections occurring on or after August 23, 2014. Accordingly, DataQs will be modified to accept RDRs related to adjudicated citations in August 2014.

Commenters expressed concern that this proposal effectively moves the decision making on roadside inspection data from the State DataQs officials to the courts, where the decisions will not be any more consistent, based on the courts' and judges' varying knowledge of CMVs, CDLs, and motor carrier safety regulations.

The IFDA expressed concern that, “. . . this continued broad delegation of authority to the states directly contradicts a primary rationale for the announced changes which is to “improve uniformity across the states. Given this obvious inconsistency, we question how much actual difference the announced changes are likely to make.”

As previously noted, FMCSA will continue and increase its outreach efforts to courts and prosecutors to remind them of the prohibition in 49 CFR 384.226 on masking convictions, deferring imposition of judgment, or allowing an individual to enter into a diversion program that would prevent a CLP or CDL holder's conviction for a violation, in any type of motor vehicle, of a State or local traffic law (other than parking, vehicle weight, or vehicle defect violations) from appearing on the CDLIS driving record.

Commenters requested more information on the Agency's definition of adequate documentation needed to demonstrate dismissal or other adjudication outcome. ATA recommended that the Agency “clearly define `adequate documentation' for the purposes of this notice.” ATA further indicated that “FMCSA must instruct States which documents are acceptable and provide motor carriers and drivers with recourse to amend their records should a State refuse to accept proof of adjudication.”

FMCSA will accept scanned copies of certified documentation from the appropriate court or administrative tribunal. Examples include but are not limited to certified records of the docket entry, the order of dismissal, or entry of a “not guilty” determination. FMCSA recognizes that the varying nature and types of tribunals may result in varying types of official documentation that contain the adjudication results, and thus the Agency has not specifically limited the type of document that must be submitted. The submitter should obtain certified documents that are clearly identified and verifiable. These documents must be uploaded into the DataQs system for verification by a State official. Alternatively, the documentation may include a Web site link to an official court Web site with adjudication results.

AAJ and ATA questioned which SMS severity weights would be used if a conviction was for a different charge than the initial cited violation. FMCSA clarifies that where the adjudication results in a conviction to a different charge, the severity weight will be reduced to a 1 in SMS. The chart in Section V.D. of this document provides more detail on the impact of changes in SMS and PSP.

For purposes of this document, the following terms have the meaning indicated.

Adequate Documentation: For the purpose of processing an RDR seeking to document the result of an adjudicated citation, FMCSA finds that scanned copies of certified documentation from the appropriate court or administrative tribunal or providing a direct web link to the adjudication results of an official court or agency Web site presents adequate and verifiable documentation of the adjudication result.

Adjudicated Citation: Refers to a citation that has been contested and resolved through a due process proceeding in a State, local, or administrative tribunal, regardless of how the action is resolved, whether by a judge or prosecutor or as part of a plea agreement or otherwise.

Citation: Refers to a notice, issued by a law enforcement officer to a CMV driver for a violation of law or an adopted FMCSR or HMR. The driver may contest the citation through a State-provided administrative or judicial system.

Conviction: This term is defined in 49 CFR 383.5 and 390.5 as an unvacated adjudication of guilt, or a determination that a person has violated or failed to comply with the law in a court of original jurisdiction or by an authorized administrative tribunal, an unvacated forfeiture of bail or collateral deposited to secure the person's appearance in court, a plea of guilty or nolo contendere accepted by the court, the payment of a fine or court costs, or violation of a condition of release without bail, regardless of whether or not the penalty is rebated, suspended, or probated.

Court Costs: FMCSA interprets “court costs” as fees imposed by a court or administrative tribunal that are intended to cover the State's expenses of handling the case. Payment of an incidental expense uniformly imposed on all persons that appear before a particular court or tribunal regardless of case outcome should not be considered a court cost under FMCSA's regulatory definition of “Conviction.” Examples of excluded, non-punitive court costs include but are not limited to scheduling fees, the cost of a certified copy of the court's docket or order, or attorney fees.

Fine: A sum of money imposed as a penalty for an offense. A court cost may be considered a fine when the amount charged exceeds the amount generally imposed for court costs and is akin to a penalty.

Unvacated: Refers to an order or judgment that has not been canceled or rescinded.

Previously, SafetyNet and MCMIS recorded inspection and violation data from the initial inspection report only and did not contain a data field that would allow the State to append the result of an adjudicated citation to the appropriate violation on the inspection report. With these changes, SafetyNet and MCMIS will be modified to provide a field that may be populated with the adjudication result of a citation associated with the related inspection report. The adjudication result will impact the use of the related violations in SMS and PSP, as indicated in the chart below in Section V.D.

FMCSA will issue revised direction to the States on receiving, reviewing, and documenting adjudication results when an RDR containing adequate documentation is submitted. Upon confirming the adequacy and accuracy of the documentation, States will enter the adjudication result in the field appending the inspection record in SafetyNet. State and Federal data systems will be modified to accept data concerning a citation associated with a violation that was dismissed or resulted in a finding of not guilty or resulted in a conviction of a different or lesser charge.

The following table indicates how the adjudication outcomes documented in MCMIS will impact the use of the cited violation in FMCSA's SMS and PSP databases:

As required by FMCSA's MCSAP regulations (49 CFR part 350), States must follow the Agency's regulatory definition of “conviction” in 49 CFR 383.5 and 390.5 and address RDRs accordingly. Thus, when an RDR indicates that a court dismissed a citation while still imposing a fine or punitive court cost, the outcome will be recorded in MCMIS as a conviction.

FMCSA regulation at 49 CFR 384.226 prohibits States from masking convictions, deferring imposition of judgment, or allowing an individual to enter into a diversion program that would prevent a CLP or CDL holder's conviction for any violation, in any type of motor vehicle, of a State or local traffic control law (other than parking, vehicle weight, or vehicle defect violations) from appearing on the CDLIS driving record, whether the driver was convicted for an offense committed in the State where the driver is licensed or another State. The Agency views the practice of courts dismissing citations after a guilty plea has been entered or following payment of a fine or mandatory contribution to a State or local program as a condition of dismissal, as “masking” of a commercial driver's violation of State or local traffic control laws. Masking convictions allows commercial drivers to accumulate multiple serious traffic safety violations without the driver's State of licensure or other States being aware of the driver's actual driving history, and it is for this safety reason that such practices are prohibited.

The changes to State and FMCSA data systems outlined in this document will enable both the Agency and the State licensing agencies to better track and document patterns and practices that are inconsistent with 49 CFR 384.226 concerning the masking prohibition. States found to have used masking or other diversionary programs may be found in substantial noncompliance and could risk decertification of their CDL programs, which could impact grant funding.

FMCSA's State Programs Division will issue direction to the MCSAP agencies explaining the expectations and responsibilities related to the adjudicated citation process. This policy will apply to inspections occurring on or after August 23, 2014, and will be included in the next version of the DataQs manual.

FMCSA will conduct training for DataQs analysts through DataQs email blasts, training bulletins and webinars. The webinars and other training will be provided to DataQs analysts before the policy is implemented to improve the consistency of implementation. The Agency will also be providing training to its own staff. In addition, information will be available on the Agency's Web site and on the DataQs Web site.

The snapper-grouper fishery of the South Atlantic, which includes red snapper, is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

On July 24, 2013, NMFS published a final rule to implement Amendment 28 to the FMP (78 FR 44461). In part, the final rule for Amendment 28 to the FMP established a process for setting commercial and recreational ACLs and determining whether limited commercial and recreational fishing seasons for red snapper in or from the South Atlantic EEZ can occur during a given fishing year. That final rule also implemented accountability measures (AMs) for South Atlantic red snapper, if limited fishing seasons are allowed in a fishing year, including setting a season length for the recreational sector and implementing an in-season closure when the commercial ACL is reached or projected to be reached. The final rule for Amendment 28 to the FMP also implemented a 75-lb (34-kg) commercial trip limit during the limited commercial fishing season and a 1-fish per person recreational bag limit during the limited recreational fishing season.

NMFS used the formulas established in Amendment 28 to the FMP to determine if harvest of red snapper could occur in 2014. In accordance with 50 CFR 622.193(y), the total removals (landings plus dead discards) for 2013 were compared to the 2013 ABC to determine if the ABC was exceeded and thus whether the ACL for 2014 could be set greater than zero. In 2013, total removals equaled 72,881 fish. Because the 2013 total removals for red snapper are less than the 2013 ABC of 96,000 fish, NMFS has determined that the ACL for 2014 can be set greater than zero and that limited commercial and recreational fishing seasons may be established in 2014.

NMFS has determined that the 2014 total ACL for red snapper in the South Atlantic EEZ is 31,386 fish. Based on the current allocation ratio for red snapper (28.07 percent commercial and 71.93 percent recreational), the 2014 commercial ACL is 50,994 lb (23,130 kg), gutted weight, and the 2014 recreational ACL is 22,576 fish. For details regarding the calculation of the commercial and recreational ACLs and the recreational season length, please see SERO-LAPP-2014-06 “2014 South Atlantic Red Snapper Annual Catch Limits and Recreational Season Length Projection”, which can be found at http://sero.nmfs.noaa.gov/sustainable_fisheries/s_atl/sg/documents/pdfs/sa_rs_acl_season_projections.pdf.

NMFS has determined the length of the recreational fishing season for 2014. The recreational fishing season will be open for three weekends consisting of 3 days the first two weekends (Friday, Saturday, Sunday) and 2 days the third weekend (Friday and Saturday). The recreational fishing season for red snapper in the South Atlantic EEZ will open at 12:01 a.m. on July 11, 2014, and close at 12:01 a.m. on July 14, 2014; open at 12:01 a.m. on July 18, 2014, and close at 12:01 a.m. on July 21, 2014; and open at 12:01 a.m. on July 25, 2014, and close at 12:01 a.m. on July 27, 2014. After the recreational sector closes, both harvest and possession of red snapper under the bag limit are prohibited.

NMFS has determined that the 2014 commercial fishing season for red snapper in the South Atlantic EEZ will open at 12:01 a.m. on July 14, 2014, and NMFS will monitor commercial harvest in-season and close the commercial sector when the commercial ACL is reached or projected to be reached by filing an in-season closure notification with the Office of the Federal Register. After the commercial sector closes, both sale and purchase of red snapper in or from the South Atlantic EEZ are prohibited. When the recreational and commercial sectors are closed, all harvest and all possession of red snapper in the South Atlantic EEZ will be prohibited.

In accordance with 50 CFR 622.183(b)(5), if the Regional Administrator, Southeast Region, NMFS, (RA) determines tropical storm or hurricane conditions exist, or are projected to exist, in the South Atlantic, during the 2014 commercial or recreational fishing season, the RA may modify the opening and closing dates of the fishing season by filing a notification to that effect with the Office of the Federal Register, and announcing via NOAA Weather Radio and a Fishery Bulletin any change in the dates of the red snapper commercial or recreational fishing season.

The RA has determined this temporary rule is necessary for the conservation and management of the South Atlantic red snapper component of the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act, the FMP, and other applicable laws.

This action is taken under 50 CFR 622.193(y) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule. Such procedures are unnecessary because the AMs established by Amendment 28 to the FMP (78 FR 44461, July 24, 2013) and located at 50 CFR 622.193(y) have already been subject to notice and comment and authorize the AA to file a notification with the Office of the Federal Register to use the established process for determining whether limited commercial and recreational fishing seasons for red snapper in the South Atlantic EEZ can occur during a given fishing year and to set commercial and recreational ACLs for red snapper during limited fishing seasons. All that remains is to notify the public of the length of the recreational fishing season, the commercial fishing season start date, and the commercial and recreational ACLs for red snapper for the 2014 fishing year. Additionally, there is a need to immediately notify the public of the fishing seasons for red snapper for the 2014 fishing year, to allow time for commercial and recreational businesses to plan their seasons. For example, charter vessel and headboat operations book trips for clients in advance and, therefore need as much time as possible to adjust business plans to account for the recreational fishing season. The commercial sector also needs to be able to plan and purchase supplies for the commercial fishing season.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The snapper-grouper fishery of the South Atlantic, which includes snowy grouper, is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

In 2013, NMFS published a temporary rule (78 FR 30779, May 23, 2013) to implement the post-season AM to reduce the 2013 fishing season for the recreational snowy grouper component of the snapper-grouper fishery. As a result, the recreational sector for snowy grouper was closed May 31, 2013, until January 1, 2014.

The recreational ACL for snowy grouper is 523 fish. In accordance with regulations at 50 CFR 622.193(b)(2), if the recreational ACL is exceeded, the Assistant Administrator, NMFS (AA) will file a notification with the Office of the Federal Register to reduce the length of the following fishing season by the amount necessary to ensure landings do not exceed the recreational ACL in the following fishing year. The most recent 3-year running average of recreational landings is compared to the recreational ACL for snowy grouper, and for the 2014 fishing year, the average of 2011-2013 recreational landings is compared to the recreational ACL. Average landings from 2011-2013 exceeded the 2013 ACL by 999 fish on average. Therefore, this temporary rule implements the post-season AM to reduce the fishing season for the recreational snowy grouper component of the snapper-grouper fishery in 2014. As a result, the recreational sector for snowy grouper will be closed effective 12:01 a.m., local time June 7, 2014.

During the closure, the bag and possession limit for snowy grouper in or from the South Atlantic exclusive economic zone is zero. The recreational sector for snowy grouper will reopen on January 1, 2015, the beginning of the 2015 recreational fishing season.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the South Atlantic snowy grouper component of the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act, the FMP, and other applicable laws.

This action is taken under 50 CFR 622.193(b)(2) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule. Such procedures are unnecessary because the AMs established by Amendment 17B to the FMP (75 FR 82280, December 30, 2010) and located at 50 CFR 622.193(b)(2) have already been subject to notice and comment and authorize the AA to file a notification with the Office of the Federal Register to reduce the duration of the recreational fishing season the following fishing year if an ACL overage occurs. All that remains is to notify the public of the reduced recreational fishing season for snowy grouper for the 2014 fishing year. Additionally, there is a need to immediately notify the public of the reduced recreational fishing season for snowy grouper for the 2014 fishing year, to prevent snowy grouper recreational harvest from further exceeding the ACL, which will help protect the South Atlantic snowy grouper resource. Also, providing prior notice and opportunity for public comment on this action would be contrary to the public interest because many of those affected by the length of the recreational fishing season, particularly charter vessel and headboat operations, book trips for clients in advance and, therefore need as much time as possible to adjust business plans to account for the reduced recreational fishing season.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The snapper-grouper fishery of the South Atlantic, which includes golden tilefish, is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

In 2013, NMFS published a temporary rule (78 FR 32995, June 3, 2013) to implement the post-season AM to reduce the 2013 fishing season for the recreational golden tilefish component of the snapper-grouper fishery. As a result, the recreational sector for golden tilefish was closed June 3, 2013, until January 1, 2014.

The recreational ACL for golden tilefish is 3,019 fish. In accordance with regulations at 50 CFR 622.193(a)(2), if recreational landings reach or are projected to reach the recreational ACL, the Assistant Administrator, NMFS (AA) will file a notification with the Office of the Federal Register to close the recreational sector for the remainder of the fishing year. If the recreational ACL is exceeded, then during the following fishing year, recreational landings will be monitored for a persistence in increased landings and, if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the following fishing season by the amount necessary to ensure landings do not exceed the recreational ACL in the following fishing year. Finalized landings data from the NMFS Southeast Fisheries Science Center indicate that the golden tilefish recreational ACL was exceeded by 1,255 fish in 2013. To account for the 2013 ACL overage and to prevent an ACL overage in 2014, the recreational sector for golden tilefish in the South Atlantic EEZ will be closed on June 7, 2014. Therefore, this temporary rule implements an AM to close the recreational golden tilefish component of the snapper-grouper fishery for the remainder of the 2014 fishing year. As a result, the recreational sector for golden tilefish in the South Atlantic EEZ will be closed effective 12:01 a.m., local time June 7, 2014.

During the closure, the bag and possession limit for golden tilefish in or from the South Atlantic EEZ is zero. The recreational sector for golden tilefish will reopen on January 1, 2015, the beginning of the 2015 recreational fishing season.

The Regional Administrator, Southeast Region, NMFS, (RA) has determined this temporary rule is necessary for the conservation and management of the South Atlantic golden tilefish component of the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(a)(2) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule. Such procedures are unnecessary because the AMs established by Regulatory Amendment 12 to the FMP (77 FR 61295, October 9, 2012) and located at 50 CFR 622.193(a)(2) have already been subject to notice and comment and authorize the AA to file a notification with the Office of the Federal Register to close the recreational sector for the remainder of the fishing year if recreational landings reach or are projected to reach the recreational ACL. All that remains is to notify the public of the recreational closure for golden tilefish for the remainder of the 2014 fishing year. Additionally, there is a need to immediately notify the public of the reduced recreational fishing season for golden tilefish for the 2014 fishing year to prevent further golden tilefish recreational harvest and prevent the ACL from being exceeded, which will protect the South Atlantic golden tilefish resource. Also, providing prior notice and opportunity for public comment on this action would be contrary to the public interest because many of those affected by the length of the recreational fishing season, particularly charter vessel and headboat operations, book trips for clients in advance and, therefore need as much time as possible to adjust business plans to account for the reduced recreational fishing season.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).