Under the regulations in “Subpart L—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-12, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world in an effort to prevent plant pests from being introduced into and spread within the United States.

Section 319.56-3, which includes general import requirements for fruits and vegetables, authorizes the importation of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia into the United States.

On February 6, 2018, we published in the Federal Register (83 FR 5179-5181, Docket No. APHIS-2017-0074) a notice  1 announcing our decision to supplement our requirements  2 governing the importation of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia into the United States and requested public comment on these changes. We also made available a pest risk assessment (PRA) and a commodity import evaluation document (CIED). The PRA evaluates the risks associated with the importation of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia into the United States and the CIED lists the phytosanitary measures necessary to ensure its safe importation into the United States.

We solicited comments concerning the additional measures for 60 days ending April 9, 2018. We received six comments during the comment period. The commenters consisted of State governments, industry representatives, and the general public. We respond to the comments below.

A few commenters stated concerns about the phytosanitary risk of importing fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia into the United States but did not address specific provisions of the notice. One such commenter stated that the risk mitigation measures listed in the notice are not stringent enough to mitigate the import risk of the 11 quarantine pests identified in the PRA.

APHIS believes that the import risk from the pests identified in the PRA will be adequately mitigated by the measures listed in the CIED. In addition, APHIS has used these and similar measures to mitigate risks successfully for pests from other countries in South America, including Argentina, Chile, Peru, and Uruguay.

Two other commenters, representing State governments, commented that their respective States have a range of climates and environments that magnify the risk of infestation from quarantine pests and recommended that APHIS not allow the resumption of imports of fresh citrus from Colombia.

APHIS acknowledges that several States have climates that are hospitable to plant pest infestations and infections. However, the mitigations of the CIED adequately address these risks.

Another commenter stated that we can grow citrus in the United States and should therefore encourage job production domestically.

Under the Plant Protection Act (7 U.S.C. 7701 et seq. ), we have 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. With respect to the commenter's point about encouraging domestic citrus production, we note that APHIS actively supports the domestic citrus industry through the Citrus Health Response Program and other initiatives.

A few commenters expressed concerns about the risk to domestic citrus production posed by Brevipalpus chilensis and other mites entering the United States via the pathway of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia.

B. chilensis is not present in Colombia. B. obovatus Donnadieu and B. phoenicis (Geijskes) are the two Brevipalpus species listed in the PRA because they are vectors of Citrus leprosis virus (CiLV). Both mite species are already present in the United States. APHIS is requiring specific measures in the CIED to mitigate the risk of Brevipalpus mites following the pathway of citrus. At the packinghouse, fruit must be washed and brushed and any damaged or diseased fruit culled. Fruit must be inspected for mites in Colombia by the Colombian national plant protection organization (NPPO). Fruit will also be inspected for mites by U.S. Customs and Border Protection (CBP) at the port of entry.

Moreover, Brevipalpus mites have limited capacity for movement. In order to transmit CiLV, the mites would have to feed on a susceptible part of the plant and acquire CiLV, move onto the fruit, survive washing and brushing, be transported to an area with suitable citrus hosts, and move from the fruit to the new host. It is highly unlikely that this combination of events would occur.

One commenter said that data was lacking to show that cold treatment kills all potential mites in transit. The commenter stated that B. chilensis has been shown to survive cold treatments on grapes from Chile.

The required cold treatment is intended to mitigate risk for fruit flies in the genera Anastrepha and Ceratitis . APHIS has not indicated that the treatment is a requirement for, or effective against, Brevipalpus mites. The packinghouse procedures referenced in the previous response will address mite risk.

The commenter also stated that the sieves used at U.S. ports to detect mites are not the correct size to detect immature stages of mites.

The commenter appears to be conflating the mitigation requirements for mites on citrus from Colombia with the systems approach mitigation for B. chilensis mites on fruit imported from Chile and Argentina. Sieving for mites is not part of the mitigation requirements proposed for Brevipalpus mites on Colombia citrus, nor is it used routinely at U.S. ports of entry.

A commenter requested proof showing that immature Brevipalpus mites associated with citrus will be detected through Colombian phytosanitary export protocols, and another stated that numerous mite species exist in Colombia, such as B. californicus, B. lewisi, and B. hondurani, with some never being evaluated as a possible vector for CiLV. The commenters asked that APHIS provide more analysis to show that mites will be adequately mitigated.

APHIS believes that the risk from mites and other pests identified in the PRA will be adequately mitigated by the measures listed in the CIED. In addition, APHIS has used these measures and other equivalent measures to mitigate risks for pests from other countries in South America including Argentina, Chile, Peru, and Uruguay. APHIS has not detected mites on commercial consignments of citrus from these countries since these measures were implemented.

Another commenter noted that the PRA includes field management practices to reduce the prevalence of B. obovatus and B. phoenicis during citrus crop production but does not consider or address mitigation measures, processes, or procedures during pre-harvest, postharvest, storage, or shipping.

The PRA states that it did not consider whether any production practices would be used to mitigate the risk of Brevipalpus mites. APHIS is requiring specific measures in the CIED to mitigate the risk of Brevipalpus mites following the pathway of citrus. At the packinghouse, fruit must be washed and brushed and any damaged or diseased fruit culled. Fruit must be inspected for mites in Colombia by the NPPO. CBP will inspect the citrus fruit for mites at the U.S. port of entry.

A commenter stated that the risk rating in the assessment of Brevipalpus should be changed from Low to Medium, noting that the mites are polyphagous, have multiple hosts, are subject to passive dissemination, and can be dispersed over large distances with the wind. The commenter stated that without adequate consideration, fresh fruit can vector the mites into the United States where they can become endemic in backyard citrus trees.

We note that the PRA currently lists the mites, as vectors for CiLV, as Medium for the risk of the mites following the pathway of commercial citrus from Colombia.

A commenter noted that the detection of a mite results in the dismissal of the entire lot for export consideration and asked why the field is not suspended from production until the scope of the pest population can be determined.

Should APHIS dismiss a lot for export consideration, we would not allow continued imports of citrus from the production site where the lot originated in Colombia to the United States until we are satisfied that such consignments will not subject the United States to an unacceptable level of pest risk.

Several commenters expressed concern about internal feeders following the pathway of fruit shipped from Colombia into the United States. Two such commenters stated that while scientific literature supports cold treatments designed for tephritid fruit flies, such treatments are ineffective for many species of Lepidoptera. The commenters asked that we provide evidence that this treatment effectively kills the citrus fruit borer.

The required cold treatment is intended to mitigate risk for fruit flies in the genera Anastrepha and Ceratitis . APHIS has not represented that the treatment is a requirement for, or effective against, Lepidoptera. APHIS has considered that for most Lepidoptera pests of fruit, inspection is a sufficient mitigation since these pests typically leave damage, frass (caterpillar excrement), and a conspicuous hole. These pests are typically removed by factors inherent in commercial production, including the requirement to produce high quality fruit for sale, culling, and inspection. APHIS has never intercepted these Lepidoptera pests in commercially produced citrus.

Two commenters stated that APHIS provided no data supporting fruit cutting as an effective method for detecting fruit flies and other internal feeders.

APHIS has not proposed that fruit cutting will be used as a standalone mitigation method for fruit flies. The inspection with a small portion of fruit cut is included to identify when high pest populations may be present that could potentially compromise a quarantine treatment. This type of inspection and the numbers used are common to many importation programs.

One commenter asked whether fruit cutting would be sustainable and effective if personnel designated by the NPPO of Colombia conduct the cutting. The commenter stated that commercial consignments from Morocco have failed under a similar systems approach.

Inspectors designated by the NPPO of Colombia have been trained in proper fruit cutting to sample for pests, and all citrus imported into the United States will be subject to additional cutting by CBP in accordance with 7 CFR part 305. With respect to the commenter's reference to pest issues in Morocco, APHIS did not identify fruit cutting in that country's export program as a contributing factor.

Two commenters representing State governments suggested to APHIS that a joint USDA/Florida/California site visit to Colombia be initiated to ensure that risk mitigation approaches are being executed effectively. The commenters opposed the entry of citrus from Colombia into their respective States until such a site visit is made.

APHIS is committed to a transparent process and an inclusive role for stakeholders in our risk analysis process and we respect the phytosanitary expertise of the State plant health personnel of Florida and California. However, we have not identified the need for additional site visits at this time to evaluate the implementation of the systems approach. Should such site visits occur, we will take the States' requests into consideration.

A commenter stated that citrus dieback, citrus tristeza, alternaria brown spot, citrus canker, citrus black spot, and sweet orange scab exist in countries in proximity to Colombia production areas, and that Huanglongbing and Asian citrus psyllid exist within Colombia itself. The commenter asked APHIS to list insect vectors (other than Brevipalpus mite species) that transmit CiLV, as well as the distribution of such pests. The commenter also asked what disease and pathogen insect vector mitigation measures will be used to protect fresh citrus fruit as a pathway from introducing citrus pathogens and their insect vectors into the United States.

Citrus canker, citrus black spot, and sweet orange scab are not known to occur in Colombia. Although CiLV and Huanglongbing are known to exist in Colombia, citrus fruit is not a pathway of either of those pests in the absence of their insect vectors. The CIED specifies multiple packinghouse procedures for Brevipalpus ; these procedures will also mitigate Asian citrus psyllid, vector of Huanglongbing.

A commenter stated that the documentation provided is incomplete for the resumption of citrus exports from Colombia. The commenter said that PRA appeared to be conducted in 2015 or early 2016, leaving stakeholders uninformed about the intervening 24 months. The commenter added that the proposal moves from a PRA to an operational workplan without a pest risk mitigation document (RMD) in the interim. The commenter stated that with no RMD and operational workplan to protect the industry and environment, there are missing pieces to this effort.

APHIS did not identify any new quarantine pests that could follow the pathway of citrus from Colombia since the PRA was completed; therefore, it is still accurate. The CIED was made available with the February 2018 Federal Register notice (see footnote 1) and provides the risk mitigation structure for the importation of citrus from Colombia. Operational workplans are documents that provide additional detail regarding day-to-day operations within an export program and can be updated as operational practices within the exporting country change.

A commenter stated that the PRA risk rating should be High for the likelihood of establishment of Neosilba spp. as it poses a significant pest risk. The commenter referred APHIS to the Brazilian citrus PRA, which states: “the introduction of Neosilba into the continental United States is likely to result in significant increases in costs of production beyond normal fluctuations.” Another commenter questioned the effectiveness of fruit cutting as a dependable detection method for Neosilba spp. The commenter asked for details about how much fruit is being cut for detection of pests.

APHIS has never intercepted Neosilba spp. in commercial citrus. Given the PRA's medium risk rating and the lack of interceptions, APHIS believes that commercial production and inspection are adequate mitigation measures for this pest. APHIS believes that this pest is primarily an invader of overripe, damaged, fallen fruit, and fruit previously infested by tephritid fruit flies. In Brazil some studies have found Neosilba spp. to be a primary infesting agent, although some of those studies used dooryard citrus, not commercial fruit. Brazil is the only country where any publications showing damage from Neosilba spp. in citrus have been published.

A commenter asked how APHIS attains funding as part of this action, and whether a trust fund has been established or a Colombian or industry reimbursement is anticipated.

APHIS typically reserves trust funds for preclearance programs. Importation of citrus from Colombia does not include a preclearance program.

Therefore, for the reasons noted above, we are affirming our addition of supplemental requirements for the importation of sweet oranges, tangerines, grapefruit, clementines, and mandarins from Colombia into the United States. The requirements are listed in the FAVIR database, which is available by following the link in footnote 2.

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including foot-and-mouth disease, bovine spongiform encephalopathy, swine vesicular disease, classical swine fever, and African swine fever (ASF). These are dangerous and destructive diseases of ruminants and swine.

Sections 94.8 and 94.17 of the regulations contain requirements governing the importation into the United States of pork and pork products from regions of the world where ASF exists or is reasonably believed to exist and imposes restrictions on the importation of pork and pork products into the United States from those regions. ASF is a highly contagious disease of wild and domestic swine that can spread rapidly in swine populations with extremely high rates of morbidity and mortality. A list of regions where ASF exists or is reasonably believed to exist is maintained on the Animal and Plant Health Inspection Service (APHIS) website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions/.

APHIS receives notice of ASF outbreaks from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other publically available sources the Administrator determines to be reliable. In a report dated August 6, 2018, the veterinary authorities of China reported to the OIE confirmation of an ASF outbreak.

Although the importation of most swine commodities from China into the United States is already restricted based on that country's classical swine fever, foot-and-mouth disease, and swine vesicular disease status, APHIS has determined that it is necessary to impose ASF-related restrictions on the importation of pork and pork products from China into the United States.

Therefore, in response to this outbreak, APHIS has added China to the list of regions where ASF exists or is reasonably believed to exist. As a result, pork and pork products, including casings, from China are subject to APHIS import restrictions designed to mitigate the risk of ASF introduction into the United States.

The purpose of these meetings is to:

1. Prioritize and recommend projects for Title II funds, and

2. Nominate and vote on a Chairperson.

The meetings are open to the public. The agendas will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by March 25, 2019 to be scheduled on the agenda for the March 29, 2019 meeting; and April 3, 2019 to be scheduled on the agenda for the April 12, 2019 meeting. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meetings. Written comments and requests for time for oral comments must be sent to Rebecca Robbins, RAC Coordinator, George Washington and Jefferson National Forests Supervisor's Office, 5162 Valleypointe Parkway, Roanoke, Virginia 24019; or by email to rebecca.robbins@usda.gov.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

I. Abstract

Title II, Section 203(o) of the United States-Panama Trade Promotion Agreement Implementation Act (the “Act”) [Pub. L. 112-43] implements the commercial availability provision provided for in Article 3.25 of the United States-Panama Trade Promotion Agreement (the “Agreement”). The Agreement entered into force on October 31, 2012. Subject to the rules of origin in Annex 4.1 of the Agreement, pursuant to the textile provisions of the Agreement, fabric, yarn, and fiber produced in Panama or the United States and traded between the two countries are entitled to duty-free tariff treatment. Annex 3.25 of the Agreement also lists specific fabrics, yarns, and fibers that the two countries agreed are not available in commercial quantities in a timely manner from producers in Panama or the United States. The items listed in Annex 3.25 are commercially unavailable fabrics, yarns, and fibers. Articles containing these items are entitled to duty-free or preferential treatment despite containing inputs not produced in Panama or the United States.

The list of commercially unavailable fabrics, yarns, and fibers may be changed pursuant to the commercial availability provision in Chapter 3, Article 3.25, Paragraphs 4-6 of the Agreement. Under this provision, interested entities from Panama or the United States have the right to request that a specific fabric, yarn, or fiber be added to, or removed from, the list of commercially unavailable fabrics, yarns, and fibers in Annex 3.25 of the Agreement.

Pursuant to Chapter 3, Article 3.25, paragraph 6 of the Agreement, which requires that the President publish procedures for parties to exercise the right to make these requests, Section 203(o)(4) of the Act authorizes the President to establish procedures to modify the list of fabrics, yarns, or fibers not available in commercial quantities in a timely manner in either the United States or Panama as set out in Annex 3.25 of the Agreement. The President delegated the responsibility for publishing the procedures and administering commercial availability requests to the Committee for the Implementation of Textile Agreements (“CITA”), which issues procedures and acts on requests through the U.S. Department of Commerce, Office of Textiles and Apparel (“OTEXA”) (See Proclamation No. 8894, 77 FR 66507, November 5, 2012).

The intent of the U.S.-Panama TPA Commercial Availability Procedures is to foster the use of U.S. and regional products by implementing procedures that allow products to be placed on or removed from a product list, on a timely basis, and in a manner that is consistent with normal business practice. The procedures are intended to facilitate the transmission of requests; allow the market to indicate the availability of the supply of products that are the subject of requests; make available promptly, to interested entities and the public, information regarding the requests for products and offers received for those products; ensure wide participation by interested entities and parties; allow for careful review and consideration of information provided to substantiate requests and responses; and provide timely public dissemination of information used by CITA in making commercial availability determinations.

CITA must collect certain information about fabric, yarn, or fiber technical specifications and the production capabilities of Panamanian and U.S. textile producers to determine whether certain fabrics, yarns, or fibers are available in commercial quantities in a timely manner in the United States or Panama, subject to Section 203(o) of the Act.

Participants in a commercial availability proceeding must submit public versions of their Requests, Responses or Rebuttals electronically (via email) for posting on OTEXA's website. Confidential versions of those submissions which contain business confidential information must be delivered in hard copy to the Office of Textiles and Apparel (OTEXA) at the U.S. Department of Commerce.

OMB Control Number: 0625-0273.

Form Number(s): N/A.

Type of Review: Regular submission.

Affected Public: Business or for-profit organizations.

Estimated Number of Respondents: 16.

Estimated Time per Response: 8 hours per Request, 2 hours per Response, and 1 hour per Rebuttal.

Estimated Total Annual Burden Hours: 89.

Estimated Total Annual Cost to Public: $5,340.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

On February 18, 2015, Commerce published in the Federal Register an antidumping duty order on solar products from Taiwan. 1 On February 1, 2019, URE requested that, pursuant to section 751(b)(1) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216(b), Commerce conduct an expedited changed circumstances review of the Order to determine that URE is the successor-in-interest to NSP, Gintech and Solartech, and accordingly, to assign URE the cash deposit rate assigned to the three predecessor companies in the second administrative review. 2

The merchandise covered by this Order is crystalline silicon photovoltaic cells, and modules, laminates and/or panels consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including building integrated materials. For a complete description of the scope of the Order, see the appendix to this notice.

Pursuant to section 751(b)(1) of the Act, Commerce will conduct a changed circumstances review upon receipt of information concerning, or a request from, an interested party for a review of an antidumping duty order which shows changed circumstances sufficient to warrant a review of the order. In its request for a changed circumstances review, URE provided information indicating that URE was formed through a merger between NSP, Gintech and Solartech. 3 This corporate restructuring constitutes changed circumstances warranting a review of the Order. 4 Therefore, in accordance with section 751(b)(1) of the Act and 19 CFR 351.216(d), we are initiating a changed circumstances review based upon the information contained in URE's submission.

In making a successor-in-interest determination, Commerce examines several factors, including, but not limited to, changes in the following: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base. 5 While no single factor or combination of factors will necessarily be dispositive in the successor-in-interest determination, generally, Commerce will consider the new company to be the successor to the previous company if the new company's resulting operation is not materially dissimilar to that of its predecessor. 6 Thus, if the record evidence demonstrates that, with respect to the production and sale of the subject merchandise, the new company operates as the same business entity as the predecessor company, Commerce may assign the new company the cash deposit rate of its predecessor. 7

URE has provided sufficient evidence to warrant a review to determine whether URE is the successor-in-interest to NSP, Gintech and Solartech for the purposes of the Order. Commerce intends to publish in the Federal Register a notice of preliminary results of the antidumping duty changed circumstances review, in accordance with 19 CFR 351.221(b)(4) and 351.221(c)(3)(i), which will set forth Commerce's preliminary factual and legal conclusions. Commerce will issue its final results of the review in accordance with the time limits set forth in 19 CFR 351.216(e).

We are issuing this notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221(b)(l).

I. Abstract

The United States and Peru negotiated the U.S.-Peru Trade Promotion Agreement (the “Agreement”), which entered into force on February 1, 2009. Subject to the rules of origin in Annex 4.1 of the Agreement, and pursuant to the textile provisions of the Agreement, fabric, yarn, and fiber produced in Peru or the United States and traded between the two countries are entitled to duty-free tariff treatment. Annex 3-B of the Agreement also lists specific fabrics, yarns, and fibers that the two countries agreed are not available in commercial quantities in a timely manner from producers in Peru or the United States. The items listed are commercially unavailable fabrics, yarns, and fibers. Articles containing these items are entitled to duty-free or preferential treatment despite containing inputs not produced in Peru or the United States.

The list of commercially unavailable fabrics, yarns, and fibers may be changed pursuant to the commercial availability provision in Chapter 3, Article 3.3, Paragraphs 5-7 of the Agreement. Under this provision, interested entities from Peru or the United States have the right to request that a specific fabric, yarn, or fiber be added to, or removed from, the list of commercially unavailable fabrics, yarns, and fibers in Annex 3-B.

Chapter 3, Article 3.3, paragraph 7 of the Agreement requires that the President publish procedures for parties to exercise the right to make these requests. The President delegated the responsibility for publishing the procedures and administering commercial availability requests to the Committee for the Implementation of Textile Agreements (“CITA”), which issues procedures and acts on requests through the U.S. Department of Commerce, Office of Textiles and Apparel (“OTEXA”) ( See Proclamation No. 8341, 74 FR 4105, January 22, 2009). Interim procedures to implement these responsibilities were published in the Federal Register on August 14, 2009. ( See Interim Procedures for Considering Requests Under the Commercial Availability Provision of the United States—Peru Trade Promotion Agreement Implementation Act and Estimate of Burden for Collection of Information, 74 FR 41111, August 11, 2009).

The intent of the U.S.-Peru TPA Commercial Availability Procedures is to foster the use of U.S. and regional products by implementing procedures that allow products to be placed on or removed from a product list, on a timely basis, and in a manner that is consistent with normal business practice. The procedures are intended to facilitate the transmission of requests; allow the market to indicate the availability of the supply of products that are the subject of requests; make available promptly, to interested entities and the public, information regarding the requests for products and offers received for those products; ensure wide participation by interested entities and parties; allow for careful review and consideration of information provided to substantiate requests and responses; and provide timely public dissemination of information used by CITA in making commercial availability determinations.

CITA must collect certain information about fabric, yarn, or fiber technical specifications and the production capabilities of Peruvian and U.S. textile producers to determine whether certain fabrics, yarns, or fibers are available in commercial quantities in a timely manner in the United States or Peru, subject to Section 203(o) of the Agreement.

Participants in a commercial availability proceeding must submit public versions of their Requests, Responses or Rebuttals electronically (via email) for posting on OTEXA's website. Confidential versions of those submissions which contain business confidential information must be delivered in hard copy to the Office of Textiles and Apparel (OTEXA) at the U.S. Department of Commerce.

OMB Control Number: 0625-0265.

Form Number(s): N/A.

Type of Review: Regular submission.

Affected Public: Business or for-profit organizations.

Estimated Number of Respondents: 16 (10 for Requests; 3 for Responses; 3 for Rebuttals).

Estimated Time per Response: 8 hours per Request, 2 hours per Response, and 1 hour per Rebuttal.

Estimated Total Annual Burden Hours: 89.

Estimated Total Annual Cost to Public: $5,340.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

On January 30, 2018, we published a final rule listing the oceanic whitetip shark as threatened under the Endangered Species Act (ESA) (83 FR 4153). The final listing rule describes the background of the listing action for the species and provides a summary of our conclusions regarding its status. For additional background and a summary of natural history and threats to the species, the reader is referred to the status review report and final listing rule (available at https://www.fisheries.noaa.gov/species/oceanic-whitetip-shark ).

NMFS is required by section 4(f) of the ESA to develop and implement recovery plans for the conservation and survival of federally listed species unless the Secretary finds that such a plan will not promote the conservation of the species. Recovery means that listed species and their ecosystems are restored, and their future secured, so that the protections of the ESA are no longer necessary. The ESA specifies that recovery plans are to include (1) a description of site-specific management actions necessary to achieve the plan's goals for the conservation and survival of the species; (2) objective, measurable criteria which, when met, would result in the species being removed from the list; and (3) estimates of the time and costs required to carry out the actions and achieve the plan's conservation goals. Under section 4(f) of the ESA, public notice and an opportunity for public review and comment are also provided during recovery plan development. This notice and request for information serves as the first public notice and opportunity for public input early in the process. Once a recovery plan has been drafted, it will be announced in the Federal Register and available on our website (see ADDRESSES section) for public review and comment before being finalized.

From April 23 through 24, 2019, NMFS will hold a workshop at the Ohana Waikiki East Hotel in Honolulu, HI to help inform our recovery planning for the oceanic whitetip shark (see DATES section). We are inviting experts in specific topic areas, including the species' biology/ecology, threats to the species and the species' habitat, and the recovery planning process itself. These experts will help us to identify potential actions to address the threats to the species, identify gaps in knowledge and associated research needs, as well as begin developing recovery criteria for the species. In particular, this workshop will focus on addressing threats related to commercial fisheries interactions. Identified experts include representatives of Federal and state agencies, scientific experts, individuals from conservation partners and nongovernmental organizations, and commercial and recreational fishermen. Information received at the workshop may be used to inform the development of other conservation decisions and actions, including the designation of critical habitat.

NMFS will provide a moderator to manage the workshop as well as a note taker to document input received. We are seeking facts and information; we will not be asking for consensus recommendations on how to recover the oceanic whitetip shark. During the workshop, there will also be a time-limited question and answer period during which attendees may ask NMFS about information presented. NMFS will prepare a summary of the workshop, noting the main points raised by the panelists and registered speakers.

This workshop will be open to the public, and a public comment period will be provided at the end of each day. If you plan to attend the workshop as an interested member of the public, please contact Chelsey Young at the address listed above by April 16, 2019, so we can ensure sufficient space for all participants and interested parties during our logistics planning.

• April 23 will focus on the status and threats to the species and recovery actions related to commercial fisheries interactions;

• April 24 will focus on recovery criteria and actions related to commercial fisheries interactions, research to fill in data gaps, and other needs.

We also invite the public to submit scientific or commercial information that may help to inform the recovery criteria and actions for the oceanic whitetip shark. We are soliciting relevant information related to the species and its habitat, including the following:

1. Criteria for removing the oceanic whitetip shark from the list of threatened and endangered species (this could be either threats-based or abundance/trends based);

2. Human activities that contribute to threats to the species;

3. Physical, biological or chemical features of the environment that limit the recovery of the oceanic whitetip shark;

4. Recovery strategies addressing threats to physical and biological features that are essential to species conservation;

5. Strategies and/or actions to recover the oceanic whitetip shark;

6. Estimates of the time and cost, and potential partners to implement recovery actions;

7. Critical knowledge gaps and/or uncertainties that need to be resolved to better inform recovery efforts; and

8. Research, monitoring, and evaluation needs to address knowledge gaps and uncertainties, or to assess the species' status, limiting factors, and threats relative to recovery goals.

Information may be submitted via the methods listed above in the ADDRESSES section.

The workshop is accessible to persons with disabilities. Send requests for sign language interpretation or other auxiliary aids at least five business days in advance to Chelsey Young at (301) 427-8491.

The meeting will be open to the public with seating on a first-come, first-served basis. The meeting agenda may change to accommodate other AAC priorities. For agenda updates and instructions to access the meeting via phone and the internet (forthcoming), please visit the AAC committee site at: http://www.cftc.gov/About/CFTCCommittees/AgriculturalAdvisory/aac_meetings. After the meeting, a transcript of the meeting will be published through a link on the CFTC's website, http://www.cftc.gov. All written submissions provided to the CFTC in any form will also be published on the CFTC's website. Persons requiring special accommodations to attend the meeting such as sign language interpretation or other ancillary aids because of a disability are asked to notify the contact person above at least (10) days in advance of the meeting.

Title of Collection: Generic Information Collection Plan for the Collection of Qualitative Feedback on the Service Delivery of the Bureau of Consumer Financial Protection.

OMB Control Number: 3170-0024.

Type of Review: Reinstatement without change of a previously approved collection of information.

Affected Public: Individuals; Private sector; and State, Local, or Tribal governments.

Estimated Number of Annual Respondents: 27,000.

Estimated Total Annual Burden Hours: 3,000.

Abstract: This generic information collection plan provides for the collection of qualitative feedback from consumers, financial institutions, and stakeholders on a wide range of services the Bureau provides in an efficient, timely manner, in accordance with the Bureau's commitment to improving service delivery. By qualitative feedback, the Bureau means information that provides useful insights on, for example, comprehension, usability, perceptions, and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. The Bureau expects this feedback to include insights into consumer, financial institution, or stakeholder perceptions, experiences, and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between the Bureau and consumers, financial institutions, and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The Bureau is proposing new collections of information pursuant to this request.

Request for Comments: The Bureau issued a 60-day Federal Register notice on October 1, 2018, 83 FR 49368, Docket Number: CFPB-2018-0032. Comments were solicited and continue to be invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be reviewed by OMB as part of its review of this request. All comments will become a matter of public record.

Call-in Information: Dial In: 310-653-2663, Meeting ID: 6729512, Password: 123456.

The purpose of this meeting is to update the public on GPS public document revisions and collect issues/comments for analysis and possible integration into future GPS public document revisions. Since the last Public Interface Control Working Group held on 12 September 2018, solutions to some of the topics have changed.

Specifically, GPS public documents will be updated to reflect how users will calculate the correct UT1 time following a leap second transition. All outstanding comments on GPS public documents will be considered in the next revision cycle (~Fall 2019). The “Virtual” 2019 Public Interface Control Working Group is open to the general public. The subject meeting will be dial-in only. For those who would like to attend and participate, we request that you register no later than May 3, 2019. Please send the registration information to SMCGPER@us.af.mil, providing your name, organization, telephone number, email address, and country of citizenship.

Comments will be collected, catalogued, and discussed as potential inclusions to the version following the current release. If accepted, these changes will be processed through the formal directorate change process for IS-GPS-200, IS-GPS-705, and IS-GPS-800. All comments must be submitted in a Comments Resolution Matrix. This form along with proposed document revisions of the documents and the official meeting notice are posted at: http://www.gps.gov/technical/icwg/meetings/2019/05.

Please submit comments to the SMC/GPS Requirements (SMC/GPER) mailbox at SMCGPER@us.af.mil by May 3, 2019. Subject review materials will be posted NLT March 20, 2019. For more information, please contact Captain Michael Telcide at 310-653-3163 or Mr. Daniel Godwin at 310-653-3640.

The EIS will assess the potential environmental consequences of the proposed action to beddown the F-22 FTU at Langley Air Force Base (AFB), Virginia, and the No Action Alternative, which consists of continuing F-22 FTU operations from a combination of Eglin AFB, Florida and Tyndall AFB, Florida. The Air Force carefully considered other alternatives for this proposed action, but based upon early internal scoping, these alternatives are not currently considered reasonable or within the scope of the proposed EIS due to known operational restrictions. Scoping comments submitted by affected public, federal, state, and local agencies, any affected Native American tribe, and other interested persons should be substantive in nature, in order to assist the Air Force in early identification of significant issues, and to ensure those issues are properly analyzed.

There is only one F-22 FTU and it consists of the F-22 aircraft in the 43rd Fighter Squadron (43 FS) and its associated T-38 aircraft in the 2d Fighter Training Squadron (2 FTS). The F-22 is the United States' premier fighter aircraft and essential to national security. It is a specialized “Fifth-Generation” fighter which introduces a large array of sensors that can detect both air and ground targets and share that data with other U.S. and Allied aircraft.

In December 2018, the Air Force sought approval from the Council of Environmental Quality (CEQ) of alternative arrangements pursuant to 40 CFR 1506.11 for implementing the procedural provisions of the National Environmental Policy Act, 42 U.S.C. 4321, et seq. (NEPA), for the interim beddown of the Air Force's F-22 FTU. The Air Force sought alternative arrangements due to emergency conditions resulting from Hurricane Michael displacing the 43 FS and 2 FTS from their home at Tyndall Air Force Base (AFB), Florida. On 21 December, 2018, the Air Force announced its decision to accept alternative arrangements proposed and approved by the Council on Environmental Quality (CEQ) for the Air Force's interim beddown of the F-22 Formal Training Unit at Eglin Air Force Base, Florida. The Air Force published a memorandum documenting the Air Force's decision to accept the CEQ's alternative arrangements in the Federal Register (84 FR 103, January 11, 2019). The alternative arrangements allowed the Air Force to comply with NEPA and temporarily restore training of replacement pilots for the F-22 FTU at Eglin AFB, by January 31, 2019.

As part of the alternative arrangements, the Air Force agreed to issue a Notice of Intent to prepare an EIS for the follow-on permanent F-22 FTU beddown, as soon as possible, but no later than April 1, 2019. This notification complies with that requirement.

Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Part 245, Use of the Government Property Clause for Repair of Government-furnished Property; OMB Control Number 0704-0557.

Affected Public: Businesses and other for-profit entities and not-for-profit institutions.

Respondent's Obligation: Required to obtain or retain benefits.

Type of Request: New submission.

Reporting Frequency: On occasion.

Number of Respondents: 766.

Responses per Respondent: 5.6.

Annual Responses: 4,290.

Average Burden per Response: .5 hours.

Annual Response Burden Hours: 2,145 (includes 1,762 response hours plus 383 recordkeeping hours).

Needs and Uses: The information collected is a result of a new DFARS requirement to use FAR clause 52.245-1, Government Property, in purchase orders for repair, maintenance, overhaul, or modification of Government property, regardless of the unit acquisition cost of the items to be repaired. Updated information for fiscal year 2018 awards of purchase orders for repairs was obtained from the Federal Procurement Data System to update the number of respondents, responses, and annual burden hours for the information collection and this notice.

The property records, receiving reports, and receipt provided in the Wide Area WorkFlow system are used by DoD for Government property accountability. The DFARS requirement for electronic notification of receipt provides assurance to the Government that repair assets have arrived at the contractor's repair facility. Moreover, in the case of repair items provided under purchase orders, contractors need only report the receipt of the repair item; no other reporting is required. Submission of the information for purchase orders for repairs facilitates compliance with DoD Instruction 4161.02 entitled “Accountability and Management of Government Contract Property,” which requires DoD components to use electronic transactions when transferring Government property to a contractor and upon return of property to DoD.

OMB Desk Officer: Ms. Jasmeet Seehra. Comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra, DoD Desk Officer, at Oira_submission@omb.eop.gov. Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection

You may also submit comments, identified by docket number and title, by the following method:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

DoD Clearance Officer: Mr. Frederick C. Licari.

Written requests for copies of the information collection proposal should be sent to Mr. Licari at: WHS/ESD Directives Division, 4800 Mark Center Drive, 2nd Floor, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

On November 19, 2009, a final rule was published in the Federal Register at 74 FR 59914, which amended the Defense Federal Acquisition Regulation Supplement (DFARS) subpart 208.6 to implement Section 827 of the National Defense Authorization Act for Fiscal Year 2008, Public Law 110-181. Section 827 changed DoD competition requirements for purchases from Federal Prison Industries, Inc. (FPI) by requiring DoD to publish an annual list of product categories for which FPI's share of the DoD market was greater than five percent, based on the most recent fiscal year data available. Product categories on the current list, and the products within each identified product category, must be procured using competitive or fair opportunity procedures in accordance with DFARS 208.602-70.

The Principal Director, Defense Pricing and Contracting (DPC), issued a memorandum dated February 26, 2019, that provided the current list of product categories for which FPI's share of the DoD market is greater than five percent based on fiscal year 2018 data from the Federal Procurement Data System. The product categories to be competed effective March 28, 2019, are the following:

The DPC memorandum with the current list of product categories for which FPI has a significant market share is posted at: https://www.acq.osd.mil/dpap/cpic/cp/specific_policy_areas.html#federal_prison.

The statute, as implemented, also requires DoD to—

(1) Include FPI in the solicitation process for these items. A timely offer from FPI must be considered and award procedures must be followed in accordance with existing policy at Federal Acquisition Regulation (FAR) 8.602(a)(4)(ii) through (v);

(2) Continue to conduct acquisitions, in accordance with FAR subpart 8.6, for items from product categories for which FPI does not have a significant market share. FAR 8.602 requires agencies to conduct market research and make a written comparability determination, at the discretion of the contracting officer. Competitive (or fair opportunity) procedures are appropriate if the FPI product is not comparable in terms of price, quality, or time of delivery; and

(3) Modify the published list if DoD subsequently determines that new data requires adding or omitting a product category from the list.

Annova requests this authorization, on its own behalf and as agent for other entities that hold title to the LNG at the point of export, for a 20-year term commencing on the earlier of the date of first commercial export or seven years from the date of the requested authorization. Annova filed the Application under section 3(a) of the Natural Gas Act (NGA), 15 U.S.C. 717b(a). Additional details can be found in Annova's Application and supplement to the Application, posted on the DOE/FE website at: https://www.energy.gov/fe/annova-lng-common-infrastructure-llc-annova-19-34-lng-long-term-nftans.

Protests, motions to intervene, notices of intervention, and written comments are invited.

In reviewing Annova's Application, DOE will consider any issues required by law or policy. DOE will consider domestic need for the natural gas, as well as any other issues determined to be appropriate, including whether the arrangement is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the study entitled, Macroeconomic Outcomes of Market Determined Levels of U.S. LNG Exports (2018 LNG Export Study), 1 and DOE/FE's response to public comments received on that Study. 2

Additionally, DOE will consider the following environmental documents:

• Addendum to Environmental Review Documents Concerning Exports of Natural Gas From the United States, 79 FR 48132 (Aug. 15, 2014);  3 and

• Life Cycle Greenhouse Gas Perspective on Exporting Liquefied Natural Gas from the United States, 79 FR 32260 (June 4, 2014). 4

Parties that may oppose this Application should address these issues and documents in their comments and/or protests, as well as other issues deemed relevant to the Application.

The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its environmental responsibilities.

In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Interested parties will be provided 60 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.

Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.

Filings may be submitted using one of the following methods: (1) Emailing the filing to fergas@hq.doe.gov, with FE Docket No. 19-34-LNG in the title line; (2) mailing an original and three paper copies of the filing to the Office of Regulation, Analysis, and Engagement at the address listed in ADDRESSES ; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation, Analysis, and Engagement at the address listed in ADDRESSES . All filings must include a reference to FE Docket No. 19-34-LNG. PLEASE NOTE: If submitting a filing via email, please include all related documents and attachments ( e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

A decisional record on the Application will be developed through responses to this Notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.

The Application is available for inspection and copying in the Office of Regulation, Analysis, and Engagement docket room, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

Purpose of the Board: To make recommendations to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).

Tentative Agenda: Meet with and hear from Department of Energy staff of the Office of Energy Efficiency and Renewable Energy. The meeting is also expected to hear from the Office of Technology Transitions and the Office of Electricity. The Board is expected to develop recommendations for the Assistant Secretary of the Office of Energy Efficiency and Renewable Energy.

Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Members of the public who wish to make oral statements pertaining to agenda items should contact Michael Li at the address or telephone number listed above. Requests to make oral comments must be received five days prior to the meeting; reasonable provision will be made to include requested topic(s) on the agenda. The Chair of the Board is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

Minutes: The minutes of the meeting will be available for public review and copying within 90 days on the STEAB website, http://www.energy.gov/eere/steab/state-energy-advisory-board .

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP), for Hydrochloric Acid Production (40 CFR part 63, subpart NNNNN) were proposed on September 18, 2001, promulgated on April 17, 2003, and amended on April 7, 2006. These regulations apply to existing and new hydrochloric acid (HCI) production facilities. New facilities include those that commenced construction or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart NNNNN. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.

Form Numbers: None.

Respondents/affected entities: Hydrochloric acid production facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart NNNNN).

Estimated number of respondents: 19 (total).

Frequency of response: Initially, occasionally and semiannually.

Total estimated burden: 22,600 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $2,742,000 (per year), which includes $16,000 for annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an adjustment decrease in burden and costs from the most recently-approved ICR. The adjustment decrease in burden is due to more accurate estimates of existing and anticipated new sources, which are based on EPA's recent re-evaluation of the source category inventory as part of a proposed rulemaking and risk and technology review for 40 CFR 63, Subpart NNNNN. We have also corrected the previous assumption that existing respondents would record startup, shutdown, and malfunction events 100 times per year. Based on information received from industry in the development of the proposed risk and technology review, this assumption has been corrected to 10 times per year. Further, as a result of the decrease in existing and new sources, there is also an adjustment decrease in the number of total annual responses and the capital and operating and maintenance costs.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Stationary Compression Ignition Internal Combustion Engines (40 CFR part 60, subpart IIII) apply to manufacturers, owners and operators of new stationary compression ignition (CI) internal combustion engines (ICE). New facilities include those that commenced construction, modification or reconstruction after the date of proposal. For the purposes of this subpart, the date that construction commences is the date the engine is ordered by the owner or operator. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS. This information is being collected to assure compliance with 40 CFR part 60, subpart IIII.

Form Numbers: None.

Respondents/affected entities: Manufacturers, owners and operators of new stationary compression ignition (CI) internal combustion engines (ICE).

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart IIII).

Estimated number of respondents: 206,885 (total).

Frequency of response: Initially and annually.

Total estimated burden: 408,000 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $46,700,000 (per year), includes $167,000 for annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no significant increase in the burden hours in this ICR compared to the previous ICR. This because the regulations have not changed significantly over the past three years and are not anticipated to change over the next three years. The increase in labor costs from the most-recently approved ICR is due to adjustment in labor rates. We also updated the number of respondents to reflect new respondents since the approval of the prior ICR. There was no change in the capital or O&M costs. There is a small increase in the number of responses based on the adjustments to the number of respondents.

Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

ICR status: This ICR is currently scheduled to expire on March 31, 2019. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Under PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number

Abstract: This ICR addresses the information collection activities associated with the statutory mandate requiring EPA to provide notice to foreign purchasers of unregistered pesticides exported from the United States that the pesticide product cannot be sold in the United States. Section 17(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires an exporter of any pesticide not registered under FIFRA section 3 or sold under FIFRA section 6(a)(1) to obtain a signed statement from the foreign purchaser acknowledging that the purchaser is aware that the pesticide is not registered for use in, and cannot be sold in, the United States. A copy of this statement; which is known as the Foreign Purchaser Acknowledgement Statement, or FPAS, must be transmitted to the Designated National Authority or appropriate official of the government in the importing country. This information is submitted in the form of annual or per-shipment statements to the EPA, which maintains original records and transmits copies, along with an explanatory letter to appropriate government officials of the countries that are importing the pesticide. In addition to the export notification for unregistered pesticides, FIFRA requires that all exported pesticides include appropriate labeling. There are different requirements for registered and unregistered products. Export labeling requirements meet the definition of third-party notification. In the interests of consolidating various related information collection requests, this ICR includes the burden estimates for the FPAS requirement for unregistered pesticides, as well as the labeling requirement for all exported pesticides, both registered and unregistered.

Respondents/Affected Entities: Individuals or entities that either manufacture and export pesticides or that reformulate or repackage and export pesticides. The North American Industrial Classification System (NAICS) code assigned to the parties responding to this information is 3250A1.

Respondent's obligation to respond: Mandatory.

Estimated total number of potential respondents: 2,240 annually.

Frequency of response: On occasion.

Estimated total burden: 16,660 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Estimated total costs: $1,087,102. This is the estimated burden cost, which includes no capital investment or maintenance and operational costs.

Changes in the estimates: There is a decrease of 1,333 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease reflects a reduction in the annual number of foreign purchaser acknowledgment statements received by EPA (from 3,024 to 2,774), which resulted in a corresponding decrease in the estimated annual burden hours for respondents (from 3,205 to 2,940 hours); and a reduction in the estimated annual burden associated with labeling requirements. The respondent burden associated with labeling requirements for unregistered exported pesticides decreased from 4,888 to 4,480 hours; and from 9,900 to 9,240 hours associated with labeling requirements for registered exported pesticides. The decrease in burden associated with labeling requirements is due to a reduction in the number of respondents per calendar years 2015-2017. Total labor costs for respondents decreased due to a decrease in the estimated number of respondents per calendar year from 2015-2017 and an update to the wage rate estimates, which incorporated higher estimates for benefits than was used in the previous renewal. These changes qualify as adjustments.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for New Residential Hydronic Heaters and Forced-Air Furnaces (40 CFR part 60, subpart QQQQ) to new residential hydronic heaters, forced-air furnaces, or other central heaters manufactured either on or after May 15, 2015 and sold or distributed in the United States. The residential hydronic heater and forced-air furnace NSPS establishes a certification program, instead of the usual NSPS requirement that each affected facility demonstrate compliance with emission limits through performance testing. Under this certification program, a single heating appliance is tested to demonstrate compliance with particulate matter (PM) emission limits for an entire model line which could consist of thousands of stoves. The use of a certification approach significantly reduces the compliance burden, including information collection, for the manufacturers of hydronic heaters and forced-air furnaces. Each manufacturer subject to Subpart QQQQ is required to keep records of all documentation pertaining to the certification testing for each model line, the results of the quality assurance program inspections, and a sealed sample of each heater or furnace upon which certification tests were performed and certification granted. Each approved test laboratory and third-party certifier must maintain records consisting of all documentation pertaining to each certification test, quality assurance program inspection and audit test. Manufacturers must also submit the test reports and other documentation to EPA when they apply for a certificate of compliance for each model line. These reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS. This information is being collected to assure compliance with 40 CFR part 60, subpart QQQQ.

Form Numbers: None.

Respondents/affected entities: New residential hydronic heaters, forced-air furnaces, or other central heaters manufactured either on or after May 15, 2015 and sold or distributed in the United States. These regulations also apply to EPA-approved testing laboratories and EPA-approved third-party certifiers.

Respondent's obligation to respond: Mandatory (40 CFR 60 Subpart QQQQ).

Estimated number of respondents: 50 respondents, consisting of 32 hydronic heater manufacturers, 7 forced-air furnace manufacturers, and 11 companies that are EPA-approved testing laboratories, third-party certifiers or both.

Frequency of response: Annual.

Total estimated burden: 4,270 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $4,770,000 (per year), which includes $4,280,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The increase in burden from the most recently-approved ICR is due to an increase in the number of respondents and an increase in the number of testing labs and third-party certifiers. The increase in burden is also due to an adjustment to the burden for reporting by third-party certifiers to include burden for submittal of certifications, QA audit program reports, and credentials. Additionally, there is an increase in the annual average capital/startup costs as compared with the costs in the previous ICR, due to a number of testing labs and third-party certifiers expected to re-apply for re-accreditation in the three-year period. The overall result is an increase in the number of responses and in the burden.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Polyvinyl Chloride and Copolymers Production Area Sources (40 CFR part 63, subpart DDDDDD) apply to existing facilities and new PVC and copolymer production facilities that are an area source of hazardous air pollutants (HAP). This ICR includes burden estimates for area sources only. Major sources are regulated under NESHAP Subpart HHHHHHH and their burdens are included in a separate ICR (OMB Control Number 2060-0666). New facilities include those that commenced construction or reconstruction after the date of proposal. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. This information is being collected to assure compliance with 40 CFR part 63, subpart DDDDDD.

Form Numbers: None.

Respondents/affected entities: Polyvinyl chloride and copolymer production area source facilities.

Respondent's obligation to respond: Mandatory (40 CFR 63, Subpart DDDDDD).

Estimated number of respondents: 4 (total).

Frequency of response: Initially, semiannually and annually.

Total estimated burden: 92,300 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $11,900,000 (per year), which includes $1,440,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an increase in the burden labor hours and cost in this ICR compared to the previous ICR. This increase is not due to any program changes. The adjustment increase in burden is due to an increase in the number of respondents to reflect one additional existing facility. There is also an adjustment increase to the operation and maintenance costs due to the additional respondent, as well as an increase in the estimated cost for testing thermal oxidizers for process vents.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Nitric Acid Plants for which Construction, Reconstruction or Modification Commenced after October 14, 2011 (40 CFR part 60 Subpart Ga) were proposed on October 14, 2011, and promulgated on August 14, 2012. These regulations apply to new nitric acid production units (NAPUs) that produce weak nitric acid by either the pressure or atmospheric pressure process. Nitrogen oxide (NO X ) is the pollutant regulated under this subpart. The standards limit nitrogen oxides, expressed as nitrogen dioxide (NO 2 ), to 0.50 lb per ton of 100 percent nitric acid produced. This information is being collected to assure compliance with 40 CFR part 60, subpart Ga. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Form Numbers: None.

Respondents/affected entities: Nitric acid production units constructed, reconstructed or modified after October 14, 2011.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart Ga).

Estimated number of respondents: 10 (total, rounded).

Frequency of response: Initially and occasionally.

Total estimated burden: 1,740 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $481,000 (per year), which includes $283,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The increase in burden from the most recently-approved ICR is due to an adjustment. The adjustment increase in burden is due to an increase in the number of new or modified sources. The change in burden for the new and existing facilities is due primarily to updated estimates of existing and anticipated new sources based on information from industry, which supports a constant growth rate. There is an increase in the number of total annual responses. This increase is due to the update in the number of respondents, as well as a correction to the prior burden estimates, which did not account for submittal of reports for malfunctions (40 CFR 60.77a(f)). Finally, there is a small adjustment increase in the capital/startup vs. operation and maintenance (O&M) costs as calculated in section 6(b)(iii) compared with the costs in the previous ICR. The increase in O&M costs reflected in this ICR is due to the increased universe of respondents.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Semiconductor Manufacturing (40 CFR part 63, subpart BBBBB) were proposed on May 8, 2002, and promulgated on May 22, 2003. These regulations apply to existing facilities and new facilities that emits or has the potential to emit, considering controls, in the aggregate, any single hazardous air pollutants (HAP) at a rate of 10 tons per year (tpy) or more or any combination of HAP at a rate of 25 tpy or more. New facilities include those that commenced construction, modification or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart BBBBB.

In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.

Form Numbers: None.

Respondents/affected entities: Semiconductor manufacturing facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart BBBBB).

Estimated number of respondents: 1 (total).

Frequency of response: Initially, occasionally and semiannually.

Total estimated burden: 41 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $5,270 (per year), which includes $550 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is no change in the labor hours in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden. There was no change in the capital/O&M cost.

The policies implemented at FAR 37.115, Uncompensated Overtime, are based on Section 834 of Public Law 101-510 (10 U.S.C. 2331). The policies require insertion of FAR provision 52.237-10, Identification of Uncompensated Overtime, in all solicitations valued above the simplified acquisition threshold, for professional or technical services to be acquired on the basis of the number of hours to be provided.

The provision requires that offerors identify uncompensated overtime hours, in excess of 40 hours per week, and the uncompensated overtime rate for direct charge Fair Labor Standards Act-exempt personnel. This permits Government contracting officers to ascertain cost realism of proposed labor rates for professional employees and discourages the use of uncompensated overtime.

A 60-day notice was published in the Federal Register at 83 FR 53875 on October 25, 2018. No comments were received.

The burden placed on offerors is the time required to identify and support any hours in excess of 40 hours per week included in their proposal or subcontractor's proposal. It is estimated that there will be 25,801 service contracts awarded annually at $250,000 or more, of which 65 percent, or 16,771, contracts will be competitively awarded. About seven proposals will be received for each contract award. Of the total 117,397 (16,771 × 7) proposals received, only 25 percent, or 29,349, proposals are expected to include uncompensated overtime hours. It is estimated that offerors will take about 30 minutes to identify and support any hours in excess of 40 hours per week included in their proposal or subcontractor's proposal.

Respondents: 29,349.

Responses per Respondent: 1.

Total Annual Responses: 29,349.

Hours per Response: .5.

Total Burden Hours: 14,675.

Affected Public: Businesses or other for-profit and not-for-profit institutions.

Frequency: Annually.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0152, Service Contracting, in all correspondence.

The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees. The Panel is authorized by section 1114(f) of the Social Security Act (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).

The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education  1 (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub. L. 105-33).

The Medicare Modernization Act of 2003 (MMA) (Pub. L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. We have had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. The successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships.

In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage. In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits.

The Patient Protection and Affordable Care Act (Pub. L. 111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP. Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace SM , or Marketplace SM   2 ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace SM . The APOE (the Panel) allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act.

The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA).

On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2019, and will terminate on January 19, 2021 unless renewed by appropriate action.

In accordance with the charter approved on January 16, 2019, the APOE was renewed. The APOE will advise the HHS and CMS on developing and implementing education programs that support individuals with or who are eligible for Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace SM about options for selecting health care coverage under these and other programs envisioned under health care reform to ensure improved access to quality care, including prevention services. The scope of this Federal Advisory Committee Act (FACA) group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA).

The charter will terminate on January 19, 2021, unless renewed by appropriate action. The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The APOE is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

In accordance with the renewed charter, the APOE will advise the Secretary of Health and Human Services and the CMS Administrator concerning optimal strategies for the following:

• Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, and the CHIP, or coverage available through the Health Insurance Marketplace SM and other CMS programs.

• Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace SM consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, and stakeholders.

• Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, CHIP, and Health Insurance Marketplace SM education programs, and other CMS programs as designated.

• Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.

• Building and leveraging existing community infrastructures for information, counseling, and assistance.

• Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act.

The current members of the Panel are: Kellan Baker, Centennial Scholar, Department of Health Policy and Management, John Hopkins Bloomberg School of Public Health; Robert Blancato, President, Matz, Blancato & Associates; Dale Blasier, Professor of Orthopaedic Surgery, Department of Orthopaedics, Arkansas Children's Hospital; Deborah Britt, Executive Director of Patient Services, Piedmont Fayette Hospital; Deena Chisolm, Associate Professor of Pediatrics and Public Health, The Ohio State University College of Medicine, The Research Institute at Nationwide Children's Hospital; Robert Espinoza, Vice President of Policy, Paraprofessional Healthcare Institute; Louise Scherer Knight, Director, Harry J. Duffey Family Patient and Family Services Program, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; Roanne Osborne-Gaskin, M.D., Medical Director/Chief Medical Officer, MercyCare Health Plans; Cathy Phan, Business Development Coordinator, Asian American Health Coalition dba HOPE Clinic; Kamilah Pickett, Director, Community Health Compass; Alvia Siddiqi, Medical Director, Advocate Physician Partners; and Tobin Van Ostern, Co-Founder, Young Invincibles Advisors.

In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the April 10, 2019 meeting will include the following:

Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the ADDRESSES section of this notice or by telephone at the number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held in a federal government building, the Hubert H. Humphrey (HHH) Building; therefore, federal security measures are applicable.

The REAL ID Act of 2005 (Pub. L. 109-13) establishes minimum standards for the issuance of state-issued driver's licenses and identification (ID) cards. It prohibits federal agencies from accepting an official driver's license or ID card from a state for any official purpose unless the Secretary of the Department of Homeland Security determines that the state meets these standards. Beginning October 2015, photo IDs (such as a valid driver's license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter federal buildings. Visitors from these states/territories will need to provide alternative proof of identification (such as a valid passport) to gain entrance into federal buildings. The current list of states from which a federal agency may accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief .

We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following:

• Presentation of a government-issued photographic identification to the Federal Protective Service or Guard Service personnel.

• Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into HHH Building, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation.

Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting.

This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).

I. Background

FDA is announcing the availability of a document entitled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry.” The purpose of this guidance is to describe the recommendations of CBER on the use of standards in product development and control as well as the use of such standards in CBER's managed review process. CBER recognizes the value of standards and encourages the use of appropriate standards in the development and control of CBER-regulated medical products. Sponsors' use of standards can facilitate product development and provide a more efficient evaluation of regulatory submissions. This guidance does not endorse the activities of specific Standards Development Organizations or recommend specific standards for use in regulatory submissions.

In the Federal Register of December 19, 2017 (82 FR 60204), FDA announced the availability of the draft guidance of the same title dated December 2017. FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated December 2017.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Congress passed the CLIA (Pub. L. 100-578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place. CLIA requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services (the Secretary), before accepting materials derived from the human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only tests that are “simple” and that have an “insignificant risk of an erroneous result” may obtain a certificate of waiver (42 U.S.C. 263a(d)(2)). The Secretary has delegated to FDA the authority to determine whether particular tests (waived tests) are “simple” and have “an insignificant risk of an erroneous result” under CLIA (69 FR 22849, April 27, 2004).

On January 30, 2008, FDA published a guidance document entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices—Guidance for Industry and FDA Staff” ( https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm ). This guidance describes recommendations for device manufacturers submitting to FDA an application for determination that a cleared or approved device meets this CLIA standard (CLIA waiver application). The guidance recommends that CLIA waiver applications include a description of the features of the device that make it “simple”; a report describing a hazard analysis that identifies potential sources of error, including a summary of the design and results of flex studies and conclusions drawn from the flex studies; a description of fail-safe and failure alert mechanisms and a description of the studies validating these mechanisms; a description of clinical tests that demonstrate the accuracy of the test in the hands of intended operators; and statistical analyses of clinical study results.

FDA estimates the burden of this collection of information as follows:

The total number of reporting and recordkeeping hours is 52,000 hours. FDA bases the burden on an Agency analysis of premarket submissions with clinical trials similar to the waived laboratory tests. Based on previous years' experience with CLIA waiver applications, FDA expects 13 manufacturers to submit one CLIA waiver application per year. The time required to prepare and submit a waiver application, including the time needed to assemble supporting data, averages 1,200 hours per waiver application for a total of 15,600 hours for reporting. Based on previous years' experience with CLIA waiver applications, FDA expects that each manufacturer will spend 2,800 hours creating and maintaining the record for a total of 36,400 hours.

The total operating and maintenance cost associated with the waiver application is estimated at $350,000. This cost is largely attributed to clinical study costs incurred, which include site selection and qualification, protocol review, and study execution (initiation, monitoring, closeout, and clinical site/subject compensation—including specimen collection for study as well as shipping and supplies).

Our estimated burden for the information collection reflects a decrease of 27 responses and 27 records, and a corresponding overall decrease of 108,000 hours. We attribute this adjustment to a decrease in the average number of submissions we received over the last few years.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Shell eggs contaminated with Salmonella Enteritidis (SE) are responsible for more than 140,000 illnesses per year. The Public Health Service Act (PHS Act) (42 U.S.C. 264) authorizes the Secretary of Health and Human Services to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States . . . or from one State . . . into any other State” (section 361(a) of the PHS Act (42 U.S.C. 264(a))). This authority has been delegated to the Commissioner of Food and Drugs. Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(4)), a food is adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act.

Under part 118 (21 CFR part 118), shell egg producers are required to implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation. Shell egg producers also are required to maintain records concerning their compliance with part 118 and to register with FDA. As described in more detail with regard to each information collection provision of part 118, each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, must refrigerate, register, and keep certain records. Farms that do not send all of their eggs to treatment are also required to have an SE prevention plan and to test for SE.

Section 118.10 of FDA's regulations requires recordkeeping for all measures the farm takes to prevent SE in its flocks. Since many existing farms participate in voluntary egg quality assurance programs, those respondents may not have to collect any additional information. Records are maintained on file at each farm site and examined there periodically by FDA inspectors.

Section 118.10 also requires each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, and does not have all of the shell eggs treated, to design and implement an SE prevention plan.

Section 118.10 requires recordkeeping for each of the provisions included in the plan and for plan review and modifications if corrective actions are taken.

Finally, § 118.11 of FDA's regulations requires that each farm covered by § 118.1(a) register with FDA using Form FDA 3733. The term “Form FDA 3733” refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at https://www.access.fda.gov. We strongly encourage electronic registration because it is faster and more convenient. The system can accept electronic registrations 24 hours a day, 7 days a week. A registering shell egg producer receives confirmation of electronic registration instantaneously once all the required fields on the registration screen are completed. However, paper registrations will also be accepted. Form FDA 3733 is available for download for registration by mail or CD-ROM.

Recordkeeping and registration are necessary for the success of the SE prevention measures. Written SE prevention plans and records of actions taken due to each provision are essential for farms to implement SE prevention plans effectively. Further, they are essential for us to be able to determine compliance. Information provided under these regulations helps us to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply. In addition, data collected through registration is used to support our enforcement activities.

Description of Respondents: Respondents to this information collection include farm sites with 3,000 or more egg laying hens that sell raw eggs to the table egg market, other than directly to the consumer.

We estimate the burden of this collection of information as follows:

We are basing our estimates for the recordkeeping burden and the reporting burden on our experience with similar recordkeeping activities and the number of registrations and cancellations received in the past 3 years.

The number of recordkeepers estimated in column 2 of table 1 is drawn from estimates of the total number of layer and pullet houses affected by part 118. We assume that those farms that were operating according to recognized industry or State quality assurance plans prior to their compliance date under part 118 were already largely in compliance with the plan design and recordkeeping provisions discussed in this section, and therefore did not experience additional costs to comply with recordkeeping provisions. We found that 59 percent of farms with more than 50,000 layers are members of State or industry quality assurance plans. Fewer than 8 percent of farms with fewer than 50,000 layers are members of quality assurance plans. Thus, we estimate the number of layer farms incurring a new recordkeeping burden because of part 118 to be 2,600, and the number of houses affected to be 4,731.

Prevention plan design (§ 118.10(a)(1)) records are kept on a per farm basis, so we assume that new prevention plan design is only undertaken by new entrants to the industry. Refrigeration records (§ 118.10(a)(3)(iv)) are also kept on a per farm basis so the estimated number of recordkeepers for this provision is 2,600.

Records of chick and pullet procurement (§ 118.10(a)(2)), rodent and other pest control (§ 118.10(a)(3)(ii)), and biosecurity (§ 118.10(a)(3)(i)) are kept on a per house basis, so the estimated number of recordkeepers for these provisions is 4,731.

Records of cleaning and disinfection (§ 118.10(a)(3)(iii)) are also kept on a per house basis, but only need to be kept in the event that a layer house tests environmentally positive for SE. Prevention plan review and modifications (§ 118.10(a)(4)) also need to be performed every time a house tests positive, which we estimate that 7.0 percent test positive. Therefore, the number of recordkeepers for these provisions is calculated to be 331 (4,731 houses × 0.070) annually.

Records of testing, diversion, and treatment (§ 118.10(a)(3)(v) through (viii)) are kept on a per house basis and include records on flocks from pullet houses. We estimate that there are one-third as many pullet houses as there are layer houses. Therefore, the total number of recordkeepers for these provisions is 6,308 (4,731 + (4,731/3)). The number of annual records kept depends on whether houses test positive for SE. Annually, 343 layer and pullet houses ((4,731 layer houses × 0.070) + (4,731/3 pullet houses) × 0.0075)) are expected to test positive and 5,965 are expected to test negative ((4,731 layer houses × 0.930) + (4,731/3 pullet houses) × 0.9925)).

We assume that refrigeration records are kept on a weekly basis on a per farm basis under § 118.10(a)(3)(iv)). We estimate that 2,600 recordkeepers maintain 52 records each for a total of 135,200 records and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for refrigeration records is calculated to be 67,600 hours (135,200 records × 0.5 hour).

We assume that records of testing, diversion, and treatment under § 118.10(a)(3)(v) through (viii) are kept weekly in the event a layer house tests environmentally positive for SE. We estimate that 343 layer and pullet houses test positive and thus 343 recordkeepers maintain 52 records each for a total of 17,836 records and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for testing, diversion, and treatment records in the event of a positive test result is calculated to be 8,918 hours (17,836 records × 0.5 hour).

Given a positive environmental test for SE, we estimate the weighted average number of egg tests per house under § 118.10(a)(3)(vii)) to be 7. We estimate that 331 recordkeepers maintain 7 records each for a total of 2,317 records and that it takes approximately 8.3 hours per recordkeeping. Thus, the total annual burden for egg testing is calculated to be 19,231 hours (2,317 records × 8.3 hours).

We estimate that all 1,577 pullet and 4,731 layer houses not testing prior to their compliance date under part 118 (6,308 recordkeepers) incur the burden of a single environmental test annually under § 118.10(a)(3)(v)). The number of samples taken during the test depends on whether a farm employs the row based method (an average of 12 samples per house) or the random sampling method (32 samples per house). We estimate that roughly 50 percent of the houses affected employ a row based method and 50 percent employ a random sampling method, implying an average of 23 samples per house. The time burden of sampling is estimated on a per swab sample basis. We assume it takes 15 minutes to collect and pack each sample. Thus, the total annual burden for environmental testing is calculated to be 36,271 hours (145,084 records × 0.25 hour).

We estimate that records of testing, diversion, and treatment under § 118.10(a)(3)(v) through (viii) are kept annually in the event a layer house tests environmentally negative for SE. We estimate that 5,965 layer and pullet houses test negative and thus 5,965 recordkeepers maintain 1 record of that testing that takes approximately 0.5 hour per record. Thus, the total annual burden for testing, diversion, and treatment records in the event of a negative test result is calculated to be 2,983 hours (5,965 records × 0.5 hour).

Prevention plan review and modifications under § 118.10(a)(4)) need to be performed every time a house tests positive. We estimate that 331 layer houses test positive requiring plan review and modifications and that it takes 10 hours to complete this work. Thus, the total annual burden for prevention plan review and modifications in the event of a positive test result is calculated to be 3,310 hours (331 records × 10 hours).

We estimate that chick and pullet procurement records under § 118.10(a)(2) is kept roughly once annually per layer house basis. We estimate that 4,731 layer houses maintain 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for chick and pullet procurement recordkeeping is calculated to be 2,366 hours (4,731 records × 0.5 hour).

We estimate that rodent and other pest control records under § 118.10(a)(3)(ii) and biosecurity records under § 118.10(a)(3)(i) are kept weekly on a per layer house basis. We assume that 4,731 layer houses maintain a weekly record under each provision. Thus, we estimate 9,462 recordkeepers maintain 52 records each for a total of 492,024 records. We estimate a recordkeeping burden of 0.5 hours per record for a total of 246,012 burden hours (492,024 records × 0.5 hour).

New prevention plan design required by § 118.10(a)(1) is only undertaken by new farms and records are kept on a per farm basis. We estimate that there are 350 new farm registrations annually, and we assume that this reflects 350 new farms requiring prevention plan design. This is an increase from our previous estimate based on new registrations received. We estimate that it takes 20 hours to complete this work. Thus, the total annual burden for prevention plan design is calculated to be 7,000 hours (350 records × 20 hours).

Cleaning and disinfection recordkeeping under § 118.10(a)(3)(iii) needs to be performed every time a house tests positive. We estimate that 331 layer houses test positive requiring 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for cleaning and disinfection recordkeeping in the event of a positive test result is calculated to be 166 hours (331 records × 0.5 hour).

This estimate is based on the average number of new shell egg producer registrations and cancellations received in the past 3 years under § 118.11. We estimate that we will receive an average of 350 registrations or updates per year over the next 3 years and that it takes the average farm 2.3 hours to register, taking into account that some respondents completing the registration may not have readily available internet access. Thus, the total annual burden for new shell egg producer registrations or updates is calculated to be 805 hours (350 respondents × 2.3 hours).

We estimate that we will receive 30 cancellations per year over the next 3 years and that cancelling a registration, on average, requires a burden of 1 hour, taking into account that some respondents may not have readily available internet access. Thus, the total annual burden for cancelling shell egg producer registrations is calculated to be 30 hours (30 cancellations × 1 hour).

We have increased our burden estimate for the information collection based on an increase in annual new farm registrations.

Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees. The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to: Preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance.

The Advisory Council is authorized to consist of not more than 30 members, including the voting and non-voting members and the Chair and Vice Chair. The current composition of the Advisory Council consists of 15 voting members, including the Chair and Vice Chair, five non-voting liaison representative members, and 10 non-voting ex-officio members.

This announcement is to solicit nominations to fill eight positions in the voting member category that are scheduled to be vacated during the 2019 calendar year, and the terms of five positions in the liaison representative category that are scheduled to be vacated during the 2020 calendar year. Voting members are appointed to serve three or four-year terms, and liaison representative members are appointed to serve a two-year term.

The eight public voting members sought for this solicitation will be selected from individuals who are engaged in: Research on, or implementation of, interventions regarding efforts to preserve the effectiveness of antibiotics by optimizing their use; advancing research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthening surveillance of antibiotic-resistant bacterial infections; preventing the transmission of antibiotic-resistant bacterial infections; advancing the development of rapid point-of-care and agricultural diagnostics; furthering research on new treatments for bacterial infections; developing alternatives to antibiotics for agricultural purposes; maximizing the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal health care providers; and improving international coordination of efforts to combat antibiotic resistance.

The public voting members will represent balanced points of view from human biomedical, public health, and agricultural fields to include surveillance of antibiotic-resistant infections, prevention and/or interruption of the spread of antibiotic-resistant threats, or development of rapid diagnostics and novel treatments. The public voting members may be physicians, veterinarians, epidemiologists, microbiologists, or other health care professionals ( e.g., nurses, pharmacists, others); individuals who have expertise and experience as consumer or patient advocates concerned with antibiotic resistance, or in the fields of agriculture and pharmaceuticals; and they also may be from state or local health agencies or public health organizations. The voting public members will be appointed by the Secretary, in consultation with the Secretaries of Defense and Agriculture. All public voting members will be classified as special government employees (SGEs).

Individuals who are appointed to serve as voting members may be allowed to receive per diem and reimbursement for any applicable expenses for travel that is performed to attend meetings of the Advisory Council as authorized by 5 U.S.C. 5703, for persons employed intermittently in the Government service. The Advisory Council meets, at a minimum, two times per fiscal year depending on the availability of funds. Meetings are open to the public, except as determined otherwise by the Secretary, or other official to whom the authority has been delegated, in accordance with guidelines under the Government in the Sunshine Act, 5 U.S.C. 552b(c).

The non-voting liaison representative members are selected from organizations and/or interest groups that have involvement in the development, testing, licensing, production, procurement, distribution, and/or use of antibiotics and/or antibiotic research. Organizations are invited to participate as non-voting liaison representatives as it is deemed necessary by the Secretary or designee to accomplish the established mission of the Advisory Council. Non-voting liaison representative members are appointed to serve two-year terms. Individuals from the following sectors are being sought to serve as non-voting liaison representatives:

• Professional organizations or associations representing providers or professionals for human and/or animal health involved in infection control and prevention; this can include physicians, nurses, pharmacists, microbiologists, veterinarians.

• Public health, environmental health, and/or animal health organizations or associations (state/territorial, county, or local) representing laboratories, health officials, epidemiologists, agricultural state departments, or environmental associations.

• Other organizations representing patients and consumer advocates, hospitals, pharmaceutical industry, food producers and retailers, or other commodity groups.

Individuals who are appointed to serve as non-voting liaison representative members may be allowed to receive per diem and reimbursement for any applicable expenses for travel that is performed to attend meetings of the Advisory Council in accordance with federal travel regulations. The Advisory Council meets, at a minimum, two times per fiscal year depending on the availability of funds. Meetings are open to the public, except as determined otherwise by the Secretary or other official to whom the authority has been delegated in accordance with guidelines under the Government in the Sunshine Act, 5 U.S.C. 552b(c).

Nominations, including self-nominations, of individuals who represent organizations that have the specified expertise and knowledge sought will be considered for appointment as non-voting liaison representative members of the Advisory Council.

Every effort will be made to ensure that the membership of federal advisory committees is fairly balanced in terms of points of view represented. Detailed information on what is required in a nomination package and how to submit one is on the Advisory Council website, http://www.hhs.gov/ash/carb/.

In-person attendance at the meetings is limited by security restrictions and the space available; therefore preregistration for public members is required and can be accomplished by registering at https://www.eventbrite.com/e/50th-meeting-of-the-hhs-advisory-committee-on-blood-tissue-safety-availability-tickets-55285257694 by Monday, April 8, 2019. Members of the public may also attend the meeting via webcast. Instructions for attending this virtual meeting will be posted prior to the meeting at: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/index.html. Non-U.S. citizens who plan to attend in person are required to provide additional information and must notify the Working Group support staff via email at tickbornedisease@hhs.gov before March 15, 2019. Members of the public who wish to attend the meetings should enter from Independence Avenue. Please allow extra time to get through security.

We encourage you to participate in this study by submitting comments and related materials to the online public docket or orally at the public meetings. All comments received will be posted, without change, to http://www.regulations.gov and will include any personal information you have provided.

A. Submitting Comments: If you submit comments to the online public docket, please include the docket number for this rulemaking (USCG-2019-0131), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. We accept anonymous comments.

To submit your comment online, go to http://www.regulations.gov, and insert “USCG-2019-0131” in the “search box.” Click “Search”. Then click “Comment Now.” We will consider all comments and material received during the comment period.

B. Public Meetings: We plan to hold two public meetings to receive oral comments on this notice. If you bring written comments to the public meeting, you may submit them to Mr. Edward G. LeBlanc. These comments will be added to our online public docket. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission. Attendance at the public meeting is not required. We will provide a written summary of the oral comments received and will place that summary in the docket.

The first public meeting on Tuesday, April 23, 2019, from 6 p.m. to 9 p.m., will be held at Corless Auditorium (Watkins Laboratory Building), University of Rhode Island, Graduate School of Oceanography, 215 South Ferry Road, Narragansett, RI 02882-1197.

The second public meeting on Thursday, April 25, 2019, from 6 p.m. to 9 p.m., will be held at Flanagan Hall, Massachusetts Maritime Academy, 101 Academy Drive, Buzzards Bay, MA 02532.

For information on facilities or services for individuals with disabilities or to request special assistance at the public meeting, contact Mr. Edward Leblanc at the telephone number or email address indicated under the FOR FURTHER INFORMATION CONTACT section of this notice.

C. Viewing the comments and documents: To view the comments and documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2019-0131” and click “Search.” Click the “Open Docket Folder” in the “Actions” column.

D. Privacy Act: Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review a Privacy Act, system of records notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316) https://www.federalregister.gov/documents/2008/01/17/E8-785/privacy-act-of-1974-system-of-records.

A. Requirement for Port Access Route Studies: Under 46 U.S.C. 70003 the Commandant of the Coast Guard may designate necessary fairways and traffic separation schemes (TSSs) to provide safe access routes for vessels proceeding to and from U.S. ports. The designation of fairways and TSSs recognizes the paramount right of navigation over all other uses in the designated areas.

Before establishing or adjusting fairways or TSSs, 46 U.S.C. 70003 requires the Coast Guard to conduct a port access route study (PARS), i.e. a study of potential traffic density and the need for safe access routes for vessels. Through the study process, we must coordinate with Federal, State, and foreign state agencies (as appropriate) and consider the views of maritime community representatives, environmental groups, and other interested stakeholders. A primary purpose of this coordination is, to the extent practicable, to reconcile the need for safe access routes with other reasonable waterway uses such as construction and operation of renewable energy facilities and other uses of the Atlantic Ocean in the study area.

B. Previous port access route studies: In 2011, the Coast Guard conducted a PARS which focused on the entire Atlantic Coast from Maine to Florida to analyze all vessel traffic proceeding to and from all Atlantic Coast ports and transiting through the United States Exclusive Economic Zone (EEZ). The Atlantic Coast Port Access Route Study Final Report is available at the Coast Guard Navigation Center website https://navcen.uscg.gov/pdf/PARS/ACPARS_Final_Report_08Jul2015_Combined_Appendix_Enclosures_Final_After_LMI_Review.pdf.

C. Necessity for a new port access route study: The Bureau of Ocean Energy Management (BOEM) has leased seven adjacent areas of the outer continental shelf (OCS) south of Martha's Vineyard and east of Rhode Island that together constitute the MA/RI Wind Energy Area (WEA). Potentially seven distinct offshore renewable energy installations (“wind farms”) could be constructed, each with its own number, size, type of wind turbines, and distinct turbine layout. The topic of safe navigation routes to facilitate vessel transit through the MA/RI WEA has been discussed at various forums throughout southeastern New England. The forums have included participation by the Coast Guard, other federal, state, and local agencies, fishing industry representatives, and a myriad of stakeholders. Various different transit plans have been proposed through these different forums.

In September 2018, the Massachusetts Coastal Zone Management Fisheries Working Group offered a vessel transit layout as depicted at https://www.mass.gov/service-details/fisheries-working-group-on-offshore-wind-energy and below:

In December 2018, the Responsible Offshore Development Alliance (RODA), https://www.rodafisheries.org/, offered an alternative layout for consideration by stakeholders:

Though neither of these alternatives achieved consensus of all stakeholders, they serve as a basis for further discussion of the issue and are provided here for that purpose. Comments on these alternative proposals are welcome, but comments need not be limited to them.

The First Coast Guard District Waterways Management Division and Coast Guard Sector Southeastern New England Waterways Management Division will conduct this PARS. The study will begin upon publication of this notice and should take approximately six months to complete.

The study area is described as an area bounded by a line connecting the following geographic positions:

• 41°20′ N, 070°00′ W;

• 40°35′ N, 070°00′ W;

• 40°35′ N, 071°15′ W;

• 41°20′ N, 071°15′ W.

Below is an illustration showing the study area.

The Coast Guard will use the PARS process described in Appendix D to Commandant Instruction 16003.2A, Marine Planning to Operate and Maintain the National Marine Transportation System (MTS) and Implement National Policy, which is available in the docket or see https://media.defense.gov/2017/Mar/15/ 2001716995/-1/-1/0/CI_16003_2A.PDF, as a guide.

We are attempting to determine what, if any, navigational safety concerns exist with vessel transits in the study area. We expect that information gathered during the study will help us identify anticipated impacts to navigation that may be experienced by mariners intending to transit in, around and through the study area which includes the MA/RI Wind Energy Area (MA/RI WEA) which is an area of wind farm leases south of Martha's Vineyard. All leases are currently being studied for development including the construction of wind energy generating turbines affixed to the sea floor. These installations could impact routes used to access ports ( e.g., transiting from Georges Bank through the MA/RI WEA to New Bedford; or from the vicinity of Montauk, NY/Point Judith, RI, to Georges Bank, etc.). Impacts could result from factors such as number, size, type, and layout of wind farm turbines and electric service platform(s), subsea cabling, increased vessel traffic, changing vessel traffic patterns, weather conditions, or navigational difficulty. Comments should include or reference data (both empirical and anecdotal) where available, published studies (academic, government, or industry), and other supporting documentation.

As part of this study, we may collect and analyze data and other information on vessel traffic characteristics and trends in an attempt to balance the needs of all waterway users.

This MARIPARS includes the following objectives:

1. Determine present vessel traffic types, patterns, and density;

2. Determine potential vessel traffic types, patterns, and density;

3. Determine if existing vessel routing measures are adequate;

4. Determine if existing vessel routing measures require modifications;

5. Determine the type of modifications;

6. Define and justify the needs for new vessel routing measures;

7. Determine the type of new vessel routing measures; and

8. Determine if the usage of the vessel routing measures must be mandatory for specific classes of vessels.

We will publish the results of the PARS in the Federal Register . It is possible the study may validate the status quo (no routing measures) and conclude that no changes are necessary. It is also possible the study may recommend one or more changes to enhance navigational safety and the efficiency of vessel traffic management. The recommendations may lead to future rulemakings or appropriate international agreements.

This notice is published under the authority of 46 U.S.C. 70004 and 5 U.S.C. 552(a).

Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that NMK Resources, Inc. 2330 Helena Street, Kenner, LA 70065, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13.

NMK Resources, Inc. (Kenner, LA) is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):

NMK Resources, Inc. (Kenner, LA) is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):

Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to CBPGaugersLabs@cbp.dhs.gov. Please reference the website listed below for a complete listing of CBP approved gaugers and accredited laboratories. http://www.cbp.gov/about/labs-scientific/commercial-gaugers-and-laboratories.

Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that NMK Resources, Inc. 1100 Walnut St., Roselle, NJ 072035, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. NMK Resources, Inc. (Roselle, NJ) is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):

NMK Resources, Inc. (Roselle, NJ) is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):

Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to CBPGaugersLabs@cbp.dhs.gov. Please reference the website listed below for a complete listing of CBP approved gaugers and accredited laboratories. http://www.cbp.gov/about/labs-scientific/commercial-gaugers-and-laboratories.

Background

The NSTS addresses the security of “transportation assets in the United States that . . . must be protected from attack or disruption by terrorist or other hostile forces. . . .” 49 U.S.C. 114(s)(3). The NSTS presents a forward-looking, risk-based plan to provide for the security and freedom of movement of people and goods while preserving civil rights, civil liberties, and privacy. It identifies objectives to enhance the security of transportation infrastructure, conveyances, workers, travelers, cargo, and operations.

Consistent with its authorities, TSA's mission is to protect the nation's transportation systems from acts of terrorism, while its vision is an agile security agency, embodied by a professional workforce, that engages its partners and the American people to outmatch a dynamic threat. The NSTS is an important part of fulfilling this mission. TSA leads the development of the NSTS through joint participation with the Department of Transportation and in consultation with government partners and industry owners and operators. The 2018 NSTS includes three objectives: (1) Manage risks to transportation systems from terrorist attacks and enhance system resilience, (2) enhance effective domain awareness of transportation systems and threats, and (3) safeguard privacy, civil liberties, and civil rights, and the freedom of movement of people and commerce.

TSA is soliciting comments through this notice to enhance the scope of consultation on the 2020 NSTS. Under the statutory requirement to develop the NSTS, TSA is also required to consult with “Federal, State, and local agencies, tribal governments, private sector entities (including nonprofit employee labor organizations), institutions of higher learning, and other entities). See 49 U.S.C. 114(s)(7). TSA has consistently met that requirement through its regular stakeholder outreach efforts. For the 2020 NSTS, TSA is publishing this notice requesting comments to enhance input and ensure there are no untapped sources of information from governments, agencies, transportation-related associations, private sector entities, labor organizations, institutions of higher learning, and other entities beyond the scope of our normal interaction with stakeholders.

TSA is specifically requesting comments on issues that have the potential for significant impacts on the security and resilience of the transportation systems. Because the 2018 NSTS was delivered to Congress on April 4, 2018, the 2020 update will only require revisions to reflect recent changes in the risk environment. Respondents are asked to provide substantive revisions for any changes. We also request that with your comment submissions, you include your name, contact information, affiliation, and the mode or sector you are representing (if applicable). TSA will consider all comments received on or before the closing date for comments. Late-filed comments will be considered to the extent practicable.

Please consider the following in your review.

• The NSTS is a counterterrorism strategy, not an all-hazards plan.

• The NSTS addresses risk-based priorities to protect vital transportation assets from terrorist attack. Consistent with 49 U.S.C. 114(s)(3)(A), the scope of vital transportation assets relevant to the NSTS is defined by whether, in the interests of national security and commerce, the asset must be protected from attack or disruption by terrorists or other hostile forces.

• The strategic environment considers the risks (threats, vulnerabilities, and potential consequences) of a terrorist attack.

TSA is specifically interested in comments on the following issues:

• Does the 2018 NSTS adequately and accurately capture risk-based priorities that identify the types of activities modal security officials in Government and industry should pursue to manage terrorism risks?

• Do the goals aggregate the major elements of the vision into basic, all-encompassing buckets ( e.g., “Manage Risks to Transportation Systems from Terrorist Attack and Enhance System Resilience” underneath the Vision of “A secure and resilient transportation system”)?

• Does the Path Forward address programmatic commitments needed to advance security of transportation assets and systems?

The most helpful comments reference a specific portion of the 2018 NSTS, explain the reason for any recommended change, and include supporting data, information, or authority that supports such a recommended change. A copy of the 2018 Biennial NSTS can be found by accessing the TSA Freedom of Information Act (FOIA) Reading Room via the following weblink: https://www.tsa.gov/sites/default/files/foia-readingroom/tsa_biennial_national_strategy_for_transportation_security_cleared_and_final_4.4.18_base_plan_pdf.pdf.

This notice supersedes a similar notice published in the Federal Register on October 3, 2016, at 81 FR 68026. Administrators of HUD rental assistance programs rely upon the accuracy of tenant-reported income to determine participant eligibility for and level of, rental assistance. The computer matching program may provide indicators of potential tenant unreported or under-reported income, which will require additional verification to identify inappropriate or inaccurate rental assistance and may provide indicators for potential administrative or legal actions. The matching program will be carried out to detect inappropriate or inaccurate rental assistance under sections 221(d)(3), 221(d)(5), and 236 of the National Housing Act, the United States Housing Act of 1937, section 101 of the Housing and Community Development Act of 1965, section 202 of the Housing Act of 1959, section 811 of the Cranston-Gonzalez National Affordable Housing Act, the Native American Housing Assistance and Self-Determination Act of 1996, and the Quality Housing and Work Responsibility Act (QHWRA) of 1998. On March 11, 2009, Section 239 of HUD's 2009 Appropriations Act modified Section 904 of the Stewart B. McKinney Act of 1988, as amended, to include the Disaster Housing Assistance program (DHAP) as a covered HUD rental assistance program in HUD computer matching activities. Specifically, the computer matching program will match HUD's tenant data to SSA's death data, Social Security (SS) and Supplemental Security Income (SSI) benefits data.

Participating Agencies: Department of Housing and Urban Development and the Social Security Administration.

Authority for Conducting the Matching Program: This matching program is being conducted pursuant to the Privacy Act of 1974 (5 U.S.C 552a); 542(b) of the 1998 Appropriations Act (Pub. L. 105-65); section 904 of the Stewart B. McKinney Homeless Assistance Amendments Act of 1988 (42 U.S.C. 3544); section 165 of the Housing and Community Development Act of 1987 (42 U.S.C. 3543); the National Housing Act (12 U.S.C. 1701-1750g); the United States Housing Act of 1937 (42 U.S.C. 1437-1437z); section 101 of the Housing and Community Development Act of 1965 (12 U.S.C. 1701s); the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4101 et seq. ); and the QHWRA Act of 1998 (42 U.S.C. 1437a(f)). The Housing and Community Development Act of 1987 authorizes HUD to require participants of HUD rental housing assistance programs to disclose their social security numbers (SSNs) to HUD as a condition of continuing (or initial) eligibility for participation in the programs. The QHWRA of 1998, section 508(d), 42 U.S.C. 1437a(f) authorizes the Secretary of HUD to require disclosure by the tenant to the PHA of income information received by the tenant from HUD as part of the income verification procedures of HUD. The QHWRA was amended by Public Law 106-74, which extended the disclosure requirements to participants in section 8, section 202, and section 811 assistance programs. The participants are required to disclose the HUD-provided income information to owners responsible for determining the participant's eligibility or level of benefits.

The Refinement of Income and Rent Determination Requirements in Public and Assisted Housing Programs: Implementation of the Enterprise Income Verification (EIV) System—Amendments; Final Rule published at 74 FR 68924 on December 29, 2009, requires program administrators to use HUD's EIV system to verify tenant income information during mandatory reexaminations or recertifications of family composition and income; and reduce administrative and subsidy payment errors in accordance with HUD administrative guidance (24 CFR 5.233).

This computer matching program also assists HUD in complying with the following federal laws, requirements, and guidance related to identifying and reducing improper payments:

1. Improper Payments Elimination and Recovery Act of 2010 (IPERA) (Pub. L. 111-204);

2. Presidential Memorandum on Enhancing Payment Accuracy Through a “Do Not Pay List” (June 18, 2010);

3. Office of Management and Budget M-10-13, Issuance of Part III to OMB Circular A-123, Appendix C;

4. Presidential Memorandum on Finding and Recapturing Improper Payments (March 10, 2010);

5. Reducing Improper Payments and Eliminating Waste in Federal Programs (Executive Order 13520, November 2009);

6. Improper Payments Information Act of 2002 (Pub. L. 107-300); and

7. Office of Management and Budget M-03-13, Improper Payments Information Act of 2002 Implementation Guide.

Purpose(s): HUD's primary objective of the computer matching program is to verify the income of participants in certain rental assistance programs to determine the appropriate level of rental assistance, and to detect, deter and correct fraud, waste, and abuse in rental housing assistance programs. In meeting these objectives, HUD also is carrying out a responsibility under 42 U.S.C. 1437f(K) to ensure that income data provided to PHAs, and O/As, by household members is complete and accurate. HUD's various rental housing assistance programs require that participants meet certain income and other criteria to be eligible for rental assistance. In addition, tenants generally are required to report and recertify the amounts and sources of their income at least annually. However, under the Quality Housing and Work Responsibility Act (QHWRA) of 1998, PHAs operating Public Housing programs may offer tenants the option to pay a flat rent, or an income-based rent. Those tenants who select a flat rent will be required to recertify income at least every three years. In addition, the changes to the Admissions and Occupancy final rule (March 29, 2000 (65 FR 16692)) specified that household composition must be recertified annually for tenants who select a flat rent or income-based rent.

Other objectives of this computer matching program include: (1) Increasing the availability of rental assistance to individuals who meet the requirements of the rental assistance programs; (2) after removal of personal identifiers, conducting analyses of the Social Security death data and benefit information, and income reporting of program participants; and (3) measure improper payments due to under-reporting of income and/or overpayment of subsidy on behalf of deceased program participants.

This notice of computer matching program applies to individuals receiving assistance from the following rental assistance programs:

Categories of Records: The following are the categories of record in this matching agreement:

HUD will provide SSA with the following information for each individual for whom HUD requests information:

SSA will provide HUD with the following information for each individual for whom HUD requests information:

System(s) of Records: SSA will conduct the matching of tenant SSNs and additional identifiers (surnames and dates of birth) to tenant data that HUD supplies from its systems of records known as the Tenant Rental Assistance Certification System (TRACS), a component of HUD's Tenant Housing Assistance and Contract Verification Data System (HUD/H-11), and the Inventory Management System (IMS), formerly known as the Public and Indian Housing Information Center (PIC) (HUD/PIH.01). The notice for these systems was published at 81 FR 56684 on August 22, 2016, and 77 FR 22337 on April 13, 2012, respectively. Program administrators utilize the form HUD-50058 module within the PIC system and the form HUD-50059 module within the TRACS to provide HUD with the tenant data.

SSA will match the tenant records included in HUD/H-11 and HUD/PIH-4 to their systems of records known as SSA's Master Files of Social Security Number Holders, and SSN Applications (60-0058), published at 75 FR 82121 on December 29, 2010; Master Beneficiary Record (60-0090), published at 71 FR 1826 on January 11, 2006; and Supplemental Security Income Record and Special Veterans Benefits (60-0103), published at 71 FR 1830 on January 11, 2006. HUD will place the resulting matched data into its Enterprise Income Verification (EIV) system (HUD/PIH-5). The notice for this system was initially published at 70 FR 41780 on July 20, 2005, and last amended on September 1, 2009 (74 FR 45235). The tenant records (one record for each family member) include these data elements: Full name, SSN, and date of birth.

HUD data will also be matched to the SSA's Master Files of Social Security Number Holders, and SSN Applications (60-0058) for the purpose of validating SSNs of participants of HUD rental assistance programs to identify noncompliance with program eligibility requirements. HUD will compare tenant SSNs provided by POAs to reveal duplicate SSNs and potential duplicate rental assistance.

The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Style Pantry LLC on March 20, 2019. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain female fashion dresses, jumpsuits, maxi skirts and accoutrements. The complaint names as respondents: Amazon.com Inc. of Seattle, WA; Xunyun of China and Jianzhang Liao of China. The complainant requests that the Commission to issue a general exclusion order and a limited exclusion order and impose a bond during the 60-day presidential review.

Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) explain how the requested remedial orders would impact United States consumers.

Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register . There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues should be filed no later than by close of business nine calendar days after the date of publication of this notice in the Federal Register . Complainant may file a reply to any written submission no later than the date on which complainant's reply would be due under § 210.8(c)(2) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(c)(2)).

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3375”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, Electronic Filing Procedures  1 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, 2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. 3

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

Overview of this information collection:

1. Type of Information Collection (check justification or form 83): Extension, without change, of a currently approved collection.

2. The Title of the Form/Collection: Certification of Qualifying State Relief From Disabilities Program.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

Form number (if applicable): ATF Form 3210.12.

Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

4. Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: State, Local or Tribal Government.

Other (if applicable): None.

Abstract: This form is used by a State to certify to the U.S. Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) that it has established a qualifying mental health relief from firearms disabilities program, based on certain minimum criteria established by the NICS Improvement Amendment Act of 2007, Public Law 110-180, Section 105, enacted January 8, 2008 (NIAA). This certification is required for States to be eligible for certain grants authorized by the NIAA.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 50 respondents will utilize the form, and it will take each respondent approximately 15 minutes to complete the form.

6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 13 hours, which is equal to 50 (# of respondents) * 1 (# of responses per respondent) * .25 (15 minutes).

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(1) Type of Information Collection: Extension of a currently approved collection.

(2) Title of the Form/Collection: Semi-Annual Progress Report for Grantees from the Sexual Assault Services Program—Grants to Culturally Specific Programs (SASP-Culturally Specific Program).

(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form Number: 1122-0023. U.S. Department of Justice, Office on Violence Against Women.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: The affected public includes the approximately 11 grantees of the SASP Culturally Specific Program. This program supports projects that create, maintain and expand sustainable sexual assault services provided by culturally specific organizations, which are uniquely situated to respond to the needs of sexual assault victims within culturally specific populations.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that it will take the approximately 11 respondents (SASP-Culturally Specific Program grantees) approximately one hour to complete a semi-annual progress report. The semi-annual progress report is divided into sections that pertain to the different types of activities in which grantees may engage. A SASP-Culturally Specific Program grantee will only be required to complete the sections of the form that pertain to its own specific activities.

(6) An estimate of the total public burden (in hours) associated with the collection: The total annual hour burden to complete the data collection forms is 22 hours, that is 11 grantees completing a form twice a year with an estimated completion time for the form being one hour.

If additional information is required contact: Melody Braswell, Deputy Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E, 405B, Washington, DC 20530.

There was an error in the Title in which “Information Collection” was added in place of “Electronic Medical Record for Implementation of” and needed to be deleted. There was an error in the second paragraph in which the words “maintain”, “digital medical records of”, “health”, “emergency treatment, and scheduled examination for active or retired astronauts in order to” needed to be deleted. These were respectively replaced with “collect information for,” “and,” “on the effects of spaceflight as well as,” “for,” to add more specificity. There was an error in the ADDRESSES section in which “Federal eRulemaking Portal: http://www.Regulations.gov . Follow the instructions on-line for submitting comments” needed to be deleted. There was an error in the Abstract section, in which “Flight medicine Clinic (FMC)” is added in place of the clinic listed as “Occupational Health Branch (OHB)” and needed to be deleted. There was an error in the Background section, in which “Collection of Information within” is added in place of “management and utilization of” and needed to be deleted. There was an error in the Background section, in which “Collection of Information within” is added in place of “management and utilization of” and needed to be deleted. There was an error in the Background section, in which “collect information from former” is added in place of “create, maintain and securely archive digital medical records and physical examination records of” and needed to be deleted. There was an error in the Background section, in which reference to records management and associated list of policies needed to be deleted. Instead the following was added in place “This information collection is conducted by clinic staff in compliance with NASA's Health Information Management System (10 HIMS) and NASA's Privacy Act System of Records Notice (SORN), consistent with NASA's privacy and information technology requirements.” There was an error in the “Method of Collection” section, in which “forms within the EMR at the JSC, FMC accessible only to authorized staff at the clinic” is added in place of “and paper” and needed to be deleted. There was an error in the Data section's Annual Number of Activities, Average number of Respondents, and Annual Responses in which “175” is added in place of “36,840” and needed to be deleted. There was an error in the Data section's Burden Hours in which “87.5” is added in place of “18,420” and needed to be deleted. There was an error in the Data section, Burden Calculation table, in which “87.5” is added in place of “18,420” and needed to be deleted. There was an error in the Data section, Burden Calculation table, in which “50” is added in place of “25.9” and needed to be deleted. There was an error in the Data section's Total Labor Burden in which “4.375” is added in place of “27,7078” and need to be deleted.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 30-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The project includes standard use of electronic forms within the Electronic Medical Records (EMR) under NASA 10 HIMS regulations at Johnson Space Center (JSC) Flight Medicine Clinic (FMC) by authorized healthcare providers assigned to, employed by, contracted to, or under partnership agreement with the JSC, FMC.

Collection of Information within the EMR at JSC, FMC clinics will be carried out in support of the TREAT Astronaut Act. The approved Public Law 115-10 states:

This law authorizes the National Aeronautics and Space Administration (NASA) to provide for:

• The medical monitoring and diagnosis of a former United States government astronaut or a former payload specialist for conditions that the Administrator considers potentially associated with human space flight; and

• the treatment of a former United States government astronaut or a former payload specialist for conditions that the Administrator considers associated with human space flight, including scientific and medical tests for psychological and medical conditions.

The FMC clinic staff at JSC will collect information from former Astronauts and payload specialists. This information collection is conducted by clinic staff in compliance with NASA's Health Information Management System (10 HIMS) and NASA's Privacy Act System of Records Notice (SORN), consistent with NASA's privacy and information technology requirements.

Electronic forms within the EMR at the JSC, FMC accessible only to authorized staff at the clinic.

Title: Information Collection for TREAT Astronauts Act. (Public Law 115-10)

OMB Number: 2700-xxxx.

Type of Review: New Clearance.

Affected Public: Astronauts and payload specialists.

Average Expected Annual Number of Activities: 175.

Average Number of Respondents per Activity: 175.

Annual Responses: 175.

Frequency of Responses: 1.

Average Minutes Per Response: 0.5 hours.

Burden Hours: 87.5.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information will have practical utility;

2. Evaluate the accuracy of NASA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Ways to enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including automated, electronic collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.

This notice informs the public of NCUA's proposal to establish and maintain a new system of records. The proposed new system is being established under NCUA's authority in the Federal Credit Union Act, 12 U.S.C. 1751, et. seq. The information collected in the NCUA-22 system of records will also support investigations and supervisory and legal proceedings by the NCUA or other supervisory or law enforcement agencies. The information collected for administrative purposes will ensure quality control, performance, and improving examination and supervision processes. This notice satisfies the Privacy Act requirement that an agency publish a system of records notice in the Federal Register when there is an addition to the agency's systems of records.

The format of NCUA-22 aligns with the guidance set forth in OMB Circular A-108. NCUA-22 and all of NCUA's Standard Routine Uses are published in full below. All of the NCUA's SORNs are available at www.ncua.gov.

This notice informs the public of NCUA's proposal to establish and maintain a new system of records. The proposed new system is being established under NCUA's authority in the Federal Credit Union Act, 12 U.S.C. 1751, et seq. The information collected in the NCUA Connect, NCUA-21 system of records is designed to provide a one-stop entry point for internal and external users, which should enhance user experience, while also streamlining security activities. This notice satisfies the Privacy Act requirement that an agency publish a system of records notice in the Federal Register when there is an addition to the agency's systems of records. The format of NCUA Connect, NCUA-21 aligns with the guidance set forth in OMB Circular A-108. NCUA-21 and all of NCUA's Standard Routine Uses are published in full below. All of the NCUA's SORNs are available at www.ncua.gov .

I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2019-0079, facility name, unit number(s), plant docket number, application date, and subject when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2019-0079.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2019-0079, facility name, unit number(s), plant docket number, application date, and subject in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.

The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.

The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. If the Commission makes a final no significant hazards consideration determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's website at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of the regulations is available at the NRC's Public Document Room, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. If a petition is filed, the Commission or a presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.

As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.

In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.

Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.

Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.

If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).

If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.

All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC website at http://www.nrc.gov/site-help/e-submittals.html. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at hearing.docket@nrc.gov, or by telephone at 301-415-1677, to (1) request a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign submissions and access the E-Filing system for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a petition or other adjudicatory document (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

Information about applying for a digital ID certificate is available on the NRC's public website at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit adjudicatory documents. Submissions must be in Portable Document Format (PDF). Additional guidance on PDF submissions is available on the NRC's public website at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the time the document is submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the document on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before adjudicatory documents are filed so that they can obtain access to the documents via the E-Filing system.

A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at http://www.nrc.gov/site-help/e-submittals.html, by email to MSHD.Resource@nrc.gov, or by a toll-free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 6 p.m., Eastern Time, Monday through Friday, excluding government holidays.

Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the Commission or the presiding officer. If you do not have an NRC-issued digital ID certificate as described above, click cancel when the link requests certificates and you will be automatically directed to the NRC's electronic hearing dockets where you will be able to access any publicly available documents in a particular hearing docket. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or personal phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. For example, in some instances, individuals provide home addresses in order to demonstrate proximity to a facility or site. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

For further details with respect to these license amendment application(s), see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.

Date of amendment request: January 17, 2019. A publicly-available version is in ADAMS under Accession No. ML19023A427.

Description of amendment request: The amendment would modify the Millstone Power Station, Unit No. 2, licensing basis by the addition of a license condition to allow for the implementation of the provisions of 10 CFR 50.69, “Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors.”

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Lillian M. Cuoco, Senior Counsel, Dominion Resources Services, Inc., 120 Tredegar Street, RS-2, Richmond, VA 23219.

NRC Branch Chief: James G. Danna.

Date of amendment request: December 13, 2018, as supplemented by letter dated February 14, 2019. Publicly-available versions are in ADAMS under Accession Nos. ML18347B366 and ML19045A011, respectively.

Description of amendment request: The amendments would modify Technical Specification (TS) requirements to permit the use of risk-informed completion times in accordance with Technical Specifications Task Force (TSTF) Traveler TSTF-505, Revision 2, “Provide Risk-Informed Extended Completion Times—RITSTF [Risk-Informed TSTF] Initiative 4b” (ADAMS Accession No. ML18183A493).

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Tamra Domeyer, Associate General Counsel, Exelon Generation Company, LLC, 4300 Winfield Road, Warrenville, IL 60555.

NRC Branch Chief: James G. Danna.

Date of amendment request: December 14, 2018. A publicly-available version is in ADAMS under Accession No. ML18351A006.

Description of amendment request: The amendment would revise Technical Specification (TS) 6.8.5 “Reactor Building Leakage Rate Testing Program.” The amendment would allow for a one-cycle extension to the 10-year frequency of the Three Mile Island Nuclear Station, Unit 1, containment leakage rate test ( i.e., Integrated Leakage Rate Test (ILRT) or Type A test). The proposed change would permit the existing ILRT to be extended from 10 years to 11.75 years. This extension would move the performance of the next ILRT from the scheduled fall 2019 refueling outage to the fall 2021 refueling outage.

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Tamra Domeyer, Associate General Counsel, Exelon Generation Company, LLC, 4300 Winfield Road, Warrenville, IL 60555.

NRC Branch Chief: James G. Danna.

Date of amendment request: December 11, 2018. A publicly-available version is in ADAMS under Accession No. ML18348A579.

Description of amendment request: The proposed amendments would modify the Operating Licenses, Appendix B, Environmental Technical Specifications, Part II, “Non-Radiological Environmental Protection Plan,” for CNP, Units 1 and 2. The amendment request would update the Environmental Protection Plan to reflect a Michigan State requirement to obtain and maintain a Renewable Operating Permit for the possession and operation of specified stationary sources of air pollutants and other editorial changes.

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involve no significant hazards consideration.

Attorney for licensee: Robert B. Haemer, Senior Nuclear Counsel, One Cook Place, Bridgman, MI 49106.

NRC Branch Chief: David J. Wrona.

Date of amendment request: February 4, 2019. A publicly-available version is in ADAMS under Accession No. ML19035A620.

Description of amendment request: The amendments would revise the Salem Technical Specification (TS) requirements on control and shutdown rods and rod and bank position indication, consistent with NRC-approved Technical Specifications Task Force (TSTF) Traveler TSTF-547, Revision 1, “Clarification of Rod Position Requirements,” dated March 4, 2016.

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Steven Fleischer, PSEG Services Corporation, 80 Park Plaza, T-5, Newark, NJ 07102.

NRC Branch Chief: James G. Danna.

Date of amendment request: April 4, 2018. A publicly-available version is in ADAMS under Package Accession No. ML18096A936.

Description of amendment request: The amendments would revise Renewed Facility Operating License Nos. NPF-5 and DPR-57 for the Hatch Nuclear Plant, Units 1 and 2, respectively. The amendments would approve the adoption of a new fire protection licensing basis which complies with the requirements in 10 CFR 50.48(a), 10 CFR 50.48(c), and the guidance in Regulatory Guide 1.205, Revision 1.

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The purpose of the proposed amendment is to permit Hatch Nuclear Plant Units 1 and 2 to adopt a new fire protection licensing basis which complies with the requirements of 10 CFR 50.48(a) and (c) and the guidance in Regulatory Guide 1.205. The NRC considers that NFPA 805 provides an acceptable methodology and performance criteria for licensees to identify fire protection requirements that are an acceptable alternative to the 10 CFR 50 Appendix R required fire protection features (69 FR 33536, June 16, 2004). Engineering analyses, which may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations, have been performed to demonstrate that the performance-based requirements of NFPA 805 have been met.

NFPA [805] taken as a whole, provides an acceptable alternative for satisfying General Design Criterion 3 (GDC 3) of Appendix A to 10 CFR 50, meets the underlying intent of the NRC's existing fire protection regulations and guidance, and provides for defense-in-depth. The goals, performance objectives, and performance criteria specified in Chapter 1 of the standard ensure that, if there are any increases in core damage frequency or risk, the increase will be small and consistent with the intent of the Commission's Safety Goal Policy.

Based on this, the implementation of the proposed amendment does not increase the probability of any accident previously evaluated. Equipment required to mitigate an accident remains capable of performing the assumed function(s). The proposed amendment will not affect the source term, containment isolation, or radiological release assumptions used in evaluating the radiological consequences of any accident previously evaluated. The applicable radiological dose criteria will continue to be met. Therefore, the consequences of any accident previously evaluated are not increased with the implementation of the proposed amendment.

2. Does the transition to NFPA 805 [proposed amendment] create the possibility of a new or different kind of accident from any accident previously evaluated?

Response: No.

Operation of Hatch Nuclear Plant Units 1 and 2 in accordance with the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated. The proposed change does not alter the requirements or functions for systems required during accident conditions. Implementation of the new fire protection licensing basis which complies with the requirements of 10 CFR 50.48(a) and (c) and the guidance [in] Regulatory Guide 1.205 will not result in new or different accidents.

The proposed amendment does not introduce new or different accident initiators, nor does it alter design assumptions, conditions, or configurations of the facility. The proposed amendment does not adversely affect the ability of structures, systems, or components to perform their design function. Structures, systems, or components required to safely shutdown the reactor and maintain it in a safe shutdown condition remain capable of performing their design functions.

The purpose of the proposed amendment is to permit Hatch Nuclear Plant Units 1 and 2 to adopt a new fire protection licensing basis which complies with the requirements of 10 CFR 50.48(a) and (c) and the guidance in Regulatory Guide 1.205. The NRC considers that NFPA 805 provides an acceptable methodology and appropriate performance criteria for licensees to identify fire protection systems and features that are an acceptable alternative to the 10 CFR 50, Appendix R required fire protection features (69 FR 33536, June 16, 2004).

The requirements of NFPA 805 address only fire protection and the impacts of fire on the plant that have previously been evaluated, with the exception of including requirements for radiological release performance criteria and non-Power Operation fire safety criteria, and alignment with plant down powers below hot shutdown. Based on this, implementation of the proposed amendment would not create the possibility of a new or different kind of accident from any kind of accident previously evaluated. No new accident scenarios, transient precursors, failure mechanisms, or limiting single failures will be introduced as a result of this amendment. There will be no adverse effect or challenges imposed on any safety-related system as a result of this amendment. Therefore, the possibility of a new or different kind of accident from any kind of accident previously evaluated is not created with the implementation of the proposed amendment.

3. Does the transition to NFPA 805 [proposed amendment] involve a significant reduction in a margin of safety?

Response: No.

Operation of Hatch Nuclear Plant Units 1 and 2 in accordance with the proposed amendment does not involve a significant reduction in the margin of safety. The proposed amendment does not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The safety analysis acceptance criteria are not affected by this change. The proposed amendment does not adversely affect existing plant safety margins or the reliability of equipment assumed to mitigate accidents in the Updated Final Safety Analysis Report. The proposed amendment does not adversely affect the ability of structures, systems, or components to perform their design function. Structures, systems, or components required to safely shut down the reactor and to maintain it in a safe shutdown condition, remain capable of performing their design functions.

The purpose of the proposed amendment is to permit Hatch Nuclear Plant Units 1 and 2 to adopt a new fire protection licensing basis which complies with the requirements in 10 CFR 50.48(a) and (c) and the guidance in Regulatory Guide 1.205. The NRC considers that NFPA 805 provides an acceptable methodology and performance criteria for licensees to identify fire protection systems and features that are an acceptable alternative to the 10 CFR 50 Appendix R required fire protection features (69 FR 33536, June 16, 2004). Engineering analyses, which may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations, have been performed to demonstrate that the performance based requirements of NFPA 805 do not result in a significant reduction in the margin of safety.

The proposed changes are evaluated to ensure that risk and safety margins are kept within acceptable limits. The risk informed fire protection scenarios and resolutions ensure fire risk analyses are performed and are only successful if adequate safety margin and defense-in-depth is maintained. Therefore, the transition to NFPA 805 does not involve a significant reduction in the margin of safety.

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Millicent Ronnlund, Vice President and General Counsel, Southern Nuclear Operating Co., Inc., P.O. Box 1295, Birmingham, AL 35201-1295.

NRC Branch Chief: Michael T. Markley.

Date of amendment request: June 7, 2018. A publicly-available version is in ADAMS under Accession No. ML18158A583.

Description of amendment request: The amendments would revise Renewed Facility Operating License Nos. DPR-57 and NPF-5 for the Hatch Nuclear Plant, Units 1 and 2, respectively, to add a condition to each license allowing for the implementation of the provisions of 10 CFR 50.69, “Risk-informed categorization and treatment of structures, systems and components [(SSCs)] for nuclear power reactors.”

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Millicent Ronnlund, Vice President and General Counsel, Southern Nuclear Operating Co., Inc., P. O. Box 1295, Birmingham, AL 35201-1295.

NRC Branch Chief: Michael T. Markley.

Date of amendment request: October 17, 2018. A publicly-available version is in ADAMS under Accession No. ML18290A940.

Description of amendment request: The amendments would modify the required actions associated with the Hatch Nuclear Plant, Units 1 and 2, Technical Specification (TS) 3.6.4.1, “Secondary Containment,” to allow up to 7 days to determine and correct the cause of secondary containment degradation when at least one combination of standby gas treatment (SGT) subsystems can maintain adequate secondary containment vacuum.

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Millicent Ronnlund, Vice President and General Counsel, Southern Nuclear Operating Co., Inc., P. O. Box 1295, Birmingham, AL 35201-1295.

NRC Branch Chief: Michael T. Markley.

Date of amendment request: November 19, 2018. A publicly-available version is in ADAMS under Accession No. ML18334A106.

Description of amendment request: The amendments would revise Renewed Facility Operating License Nos. NPF-4 and NPF-7 for the North Anna Power Station, Units 1 and 2, respectively, by approving the installation of two non-safety-related water headers (fire protection and domestic water) within the safety-related flood protection dike, along with corresponding changes to the Updated Final Safety Analysis Report (UFSAR).

Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

Attorney for licensee: Mr. W.S. Blair, Senior Counsel, Dominion Energy Services, Inc., 120 Tredegar Street, RS-2, Richmond, VA 23219.

NRC Branch Chief: Michael T. Markley.

During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register as indicated.

Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.

For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.

Date of amendment request: August 27, 2018.

Brief description of amendments: The amendments revised compensatory measures in the Peach Bottom Atomic Power Station, Units 2 and 3, Technical Requirements Manual to permit operation of the Leading Edge Flow Meter (LEFM) system at three separate intermediate power levels for an indefinite period when the mass flow input to the core thermal power calculation is from one, two, or three feedwater lines in Check mode with none in Fail mode, and to permit operation of the LEFM system at a fourth intermediate power level when not more than one LEFM is in Fail mode and flow measurement is being provided by the associated feedwater flow nozzle. The changes allow operation at power levels commensurate with the uncertainties in the measurement of core thermal power and reduce the magnitude of the required reactivity maneuver and plant power level change for degradation of the LEFM system.

Date of issuance: February 26, 2019.

Effective date: As of the date of issuance and shall be implemented immediately upon issuance.

Amendment Nos.: 324 (Unit 2) and 327 (Unit 3). A publicly-available version is in ADAMS under Accession No. ML19039A223; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

Renewed Facility Operating License Nos. DPR-44 and DPR-56: The amendments revised Section 3.20 of the Technical Requirements Manual.

Date of initial notice in Federal Register: November 6, 2018 (83 FR 55566).

The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 26, 2019.

No significant hazards consideration comments received: No.

Date of amendment request: May 30, 2018, as supplemented by letter dated December 6, 2018.

Brief description of amendments: The amendments revised the Peach Bottom Atomic Power Station, Units 2 and 3, Technical Specifications to allow continued operation with two safety relief valves/safety valves out of service and to increase the reactor coolant system pressure safety limit. Specifically, the amendments revised Technical Specification Safety Limit 2.1.2 and Limiting Condition for Operation 3.4.3 for both Units 2 and 3.

Date of issuance: February 26, 2019.

Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

Amendment Nos.: 323 (Unit 2) and 326 (Unit 3). A publicly-available version is in ADAMS under Accession No. ML19011A325; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

Renewed Facility Operating License Nos. DPR-44 and DPR-56: The amendments revised the Renewed Facility Operating Licenses and Technical Specifications.

Date of initial notice in Federal Register : November 6, 2018 (83 FR 55564). The supplemental letter dated December 6, 2018, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the NRC staff's original proposed no significant hazards consideration determined as published in the Federal Register .

The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 26, 2019.

No significant hazards consideration comments received: No.

Date of amendment request: August 23, 2018.

Brief description of amendments: The amendments modified the Technical Specification requirements for inoperable dynamic restraints (snubbers) by adding a new Limiting Condition for Operation (LCO) 3.0.8. The changes are based on Technical Specifications Task Force (TSTF) Traveler TSTF 372, Revision 4, “Addition of LCO 3.0.8, Inoperability of Snubbers.”

Date of issuance: February 28, 2019.

Effective date: As of the date of issuance and shall be implemented no later than May 31, 2019.

Amendment Nos.: 234 and 197. A publicly-available version is in ADAMS under Accession No. ML19036A913; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

Renewed Facility Operating License Nos. NPF-39 and NPF-85: The amendments revised the Renewed Facility Operating License and Technical Specifications.

Date of initial notice in Federal Register: October 23, 2018 (83 FR 53513).

The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 28, 2019.

No significant hazards consideration comments received: No.

Date of amendment request: March 28, 2018, as supplemented by letter dated October 28, 2018.

Brief description of amendment: The amendment revised various Technical Specification (TS) sections associated with steam generators to allow the use of Westinghouse leak-limiting Alloy 800 sleeves for an additional three fuel cycles of operation, bringing the total usage time from five to eight fuel cycles of operation. The Technical Specification changes also clarified wording in two sections related to use of the leak-limiting Alloy 800 sleeves.

Date of issuance: February 25, 2019.

Effective date: As of the date of issuance and shall be implemented within 60 days.

Amendment No.: 193. A publicly-available version is in ADAMS under Accession No. ML18348B206; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

Renewed Facility Operating License No. NPF-73: The amendment revised the Renewed Facility Operating License and Technical Specifications.

Date of initial notice in Federal Register: June 5, 2018 (83 FR 26105). The supplemental letter dated October 28, 2018, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the NRC staff's original proposed no significant hazards consideration determination as published in the Federal Register .

The Commission's related evaluation of the amendments is contained in a safety evaluation dated February 25, 2019.

No significant hazards consideration comments received: No.

Date of amendment request: June 29, 2018.

Brief description of amendments: The amendments revised Technical Specification requirements in Section 3/4.0, “Applicability,” regarding limiting condition for operation and surveillance requirement usage. These changes are consistent with NRC-approved Technical Specifications Task Force (TSTF) Traveler TSTF-529, “Clarify Use and Application Rules.”

Date of issuance: March 6, 2019.

Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

Amendment Nos.: 214 (Hope Creek), 327 (Salem, Unit No. 1), and 308 (Salem, Unit No. 2). A publicly-available version is in ADAMS under Accession No. ML19044A627; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

Renewed Facility Operating License Nos. NPF-57, DPR-70, and DPR-75: The amendments revised the Renewed Facility Operating Licenses and Technical Specifications.

Date of initial notice in Federal Register: August 14, 2018 (83 FR 40351).

The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated March 6, 2019.

No significant hazards consideration comments received: No.

Date of amendment request: October 8, 2018, as supplemented by letter dated February 22, 2019.

Brief description of amendment: The amendment revised the surveillance frequency of Technical Specification 3/4.4.6 Reactor Coolant System Leakage, Surveillance Requirement 4.4.6.2.2 a, to allow the reactor coolant system pressure isolation valve leakage test to be extended to a performance-based frequency not to exceed 3 refueling outages (to a maximum of 60 months) following two consecutive satisfactory tests.

Date of issuance: March 7, 2019.

Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

Amendment No.: 213. A publicly-available version is in ADAMS under Accession No. ML19023A420, documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

Renewed Facility Operating License No. NPF-12: The amendment revised the Renewed Facility Operating License and the Technical Specification.

Date of initial notice in Federal Register: November 20, 2018 (83 FR 58615). The supplemental letter dated February 22, 2019, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register .

The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated March 7, 2019.

No significant hazards consideration comments received: No.

Date of amendment request: January 16, 2018, as supplemented by letters dated June 13, and September 18, 2018.

Brief description of amendments: The amendments authorized changes to the North Anna and Surry emergency plans and allowed the consolidation of both sites' previous emergency operations facilities into a central emergency operations facility.

Date of issuance: February 27, 2019.

Effective date: As of the date of issuance and shall be implemented within 180 days of issuance.

Amendment Nos.: 281 (Unit No. 1) and 264 (Unit No. 2) for North Anna, and 294 (Unit No. 1) and 294 (Unit No. 2) for Surry. A publicly-available version is in ADAMS under Accession No. ML19031B227; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

Renewed Facility Operating License Nos. NPF-4, NPF-7, DPR-32, and DPR-37: The amendments revised the North Anna and Surry emergency plans.

Date of initial notice in Federal Register: September 11, 2018 (83 FR 45981). The supplemental letters dated June 13, and September 18, 2018, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register .

The Commission's related evaluation of these amendments is contained in a Safety Evaluation dated February 27, 2019.

No significant hazards consideration comments received: No.