Title: Performance Reporting System, Management Evaluation.

OMB Number: 0584-0010.

Expiration Date: October 31, 2022.

Type of Request: Extension, without change, of a currently approved collection.

Abstract: The purpose of the Performance Reporting System (PRS) is to ensure that each State agency and project area is operating the Supplemental Nutrition Assistance Program (SNAP) in accordance with the requirements of the Food and Nutrition Act of 2008 (the Act) (7 U.S.C. 2011, et seq. ), as amended, and corresponding program regulations. Under Section 11 of the Act (7 U.S.C. 2020), State agencies must maintain necessary records to ascertain that SNAP is operating in compliance with the Act and regulations and must make these records available to the Food and Nutrition Service (FNS) for inspection and audit.

Per Code of Federal Regulations (CFR) Part 275, each State agency is required to submit one Management Evaluation (ME) review schedule every one, two, or three years, depending on the project area make-up of the State, unless the State receives approval for an alternative Management Evaluation review schedule.

Under 7 CFR part 275, each State must establish a system for analysis and evaluation of all data available to the State. Data analysis and evaluation is an ongoing process that facilitates the development of effective and prompt corrective action.

Under 7 CFR part 275, State agencies must prepare a corrective action plan (CAP) addressing identified deficiencies. The State agencies must develop a system for monitoring and evaluating corrective action and submit CAP updates, as necessary.

Affected Public: State, Local and Tribal Government; Respondent Type: SNAP State and local agencies.

Estimated Number of Respondents: 53 State agencies.

Estimated Number of Responses per Respondent: State agencies will submit one review schedule and one corrective action plan per year, and will conduct and document ME reviews for an average total of 27 project areas, totaling 29 responses per State agency.

Estimated Total Annual Responses: 1,537 (53 State agencies * 29 estimated responses per State Agency).

Estimated Time per Response: FNS estimates that it takes 4 hours to prepare a review schedule, and that each of the 53 State agencies will submit one review schedule per year resulting in a total burden of 212 hours (53 State agencies * 1 review schedule * 4 hours). FNS estimates that it takes on average approximately 80 hours to develop a comprehensive State and local corrective action plan, resulting in a total of 4,240 hours (80 hours * 53 State plans). FNS estimates that it takes an average of 340 hours to conduct a review. It is estimated that ME reviews are conducted for one-half of the total number of project areas (1,430). Therefore, FNS estimates that it takes approximately 486,200 hours annually for State agencies to conduct their reviews (340 hours × 1,430 ME reviews). FNS also estimates that the time necessary for recordkeeping, that is, the time required for State agencies to document and maintain the findings of an ME review for internal purposes is 0.1169 hours, or 7 minutes, per State record. If State agencies each maintain approximately 29 records, then the total amount of time for recordkeeping required is 180 hours (1,537 records * 0.1169 hours).

See the table below for estimated total annual burden for each type of respondent.

The total estimated annual reporting burden is as follows:

Estimated Total Annual Burden on Respondents: 29,449,920 minutes (490,832 hours).

Background

In accordance with the provisions of FACA, the Secretary of Agriculture is seeking nominations for the purpose of improving collaborative relationships among people who use and care for National Forests and provide advice and recommendations to the Forest Service concerning projects and funding consistent with SRS Title II. The duties of SRS RACs include monitoring projects, advising the Secretary on the progress and results of monitoring efforts, and making recommendations to the Forest Service for any appropriate changes or adjustments to the projects being monitored by the SRS RACs.

The SRS RACs will be comprised of 15 members, no fewer than 9 members in accordance with the Agriculture Improvement Act of 2018; hereafter, 2018 Farm Bill. Members will be approved by the Secretary of Agriculture except in Arizona and Montana, where they will be approved by the Regional Forester and each will serve a 4-year term. SRS RACs membership will be balanced in terms of the points of view represented and functions to be performed. The SRS RACs shall include representation from the following interest areas:

(1) Five persons who represent:

(a) Organized Labor or Non-Timber Forest Product Harvester Groups,

(b) Developed Outdoor Recreation, Off-Highway Vehicle Users, or Commercial Recreation Activities,

(c) Energy and Mineral Development, or Commercial or Recreational Fishing Groups,

(d) Commercial Timber Industry, or

(e) Federal Grazing Permit or Other Land Use Permit Holders, or Representative of Non-Industrial Private Forest Land Owners, within the area for which the committee is organized.

(2) Five persons who represent:

(a) Nationally or Regionally Recognized Environmental Organizations,

(b) Regionally or Locally Recognized Environmental Organizations,

(c) Dispersed Recreational Activities,

(d) Archaeology and History, or

(e) Nationally or Regionally Recognized Wild Horse and Burro Interest, Wildlife Hunting Organizations, or Watershed Associations.

(3) Five persons who represent:

(a) Hold State Elected Office,

(b) Hold County or Local Elected Office,

(c) American Indian Tribes within or adjacent to the area for which the committee is organized,

(d) Area School Officials or Teachers, or

(e) Affected Public at Large.

In accordance with Section 8702 of the Agriculture Improvement Act of 2018, the Secretary may grant a composition waiver to modify the membership requirements for a RAC. After this Federal Register Notice of solicitation for candidates is published, the Secretary may reduce the membership composition “to not fewer than 9” members, provided an adequate number of qualified candidates are not interested or available to serve on a Resource Advisory Committee. Under this waiver, the membership requirements under the categories of interest (a), (b), and (c) may reduce to 3 members in each category as described above. In the event that a vacancy arises, the Designated Federal Officer (DFO) may fill the vacancy in the manner in which the original appointments were made. In accordance with the SRS Act, members of the SRS RAC shall serve without compensation. SRS RAC members may be allowed travel expenses and per diem for attendance at committee meetings, subject to approval of the DFO responsible for administrative support to the SRS RAC.

The appointment of members to the SRS RACs will be made by the Secretary of Agriculture except for appointments under the 2018 Agriculture Improvement Act (Pub. L. 115-334)—2018 Farm Act's Pilot Program. The Secretary plans to carry out the program to allow Regional Foresters to appoint members to the SRS RACs within the states of Arizona and Montana.

The public is invited to submit nominations for membership on the SRS RACs, either as a self-nomination or a nomination of any qualified and interested person. Any individual or organization may nominate one or more qualified persons to represent the interest areas listed above. To be considered for membership, nominees must:

1. Be a resident of the State in which the SRS RAC has jurisdiction,

2. Identify what interest group they would represent and how they are qualified to represent that interest group,

3. Provide a cover letter stating why they want to serve on the SRS RAC and what they can contribute,

4. Provide a resume showing their past experience in working successfully as part of a group working on forest management activities,

5. Complete Form AD-755, Advisory Committee or Research and Promotion Background Information. The Form AD-755 may be obtained from the Regional Coordinators listed below or from the following SRS RACs website: http://www.fs.usda.gov/main/pts/specialprojects/racs. All nominations will be vetted by the Agency.

Nominations and completed applications for SRS RACs should be sent to the appropriate Forest Service Regional Offices listed below:

Julie Kies, Northern Regional Coordinator, Forest Service, Federal Building, 200 East Broadway, Missoula, Montana 59807-7669, (406) 329-3680.

Olivia Walker, Rocky Mountain Regional Coordinator, Forest Service, 740 Simms Street, Golden, Colorado 80401, (858) 674-2984.

Veronica Van Hulle, Southwestern Regional Coordinator, Forest Service, 333 Broadway SE, Albuquerque, New Mexico 87102, (505) 842-3293.

Andy Brunelle, Intermountain Regional Coordinator (Idaho/Utah), Forest Service, Federal Building, 324 25th Street, Ogden, Utah 84401, (208) 344-1770.

Cheva Gabor, Intermountain Regional Coordinator (Nevada), Forest Service, 35 College Drive, South Lake Tahoe, California 96150, (530) 543-2600.

Denise Adamic, Pacific Southwest Regional Coordinator, Forest Service, 1323 Club Drive, Vallejo, California 94592, (808) 600-2970.

Brenna White, Pacific Northwest Regional Office, Forest Service, 1220 Southwest 3rd Avenue, Portland, Oregon 97204, (503) 808-2246.

Michael Williams, Southern Regional Coordinator, Forest Service, 1720 Peachtree Road, Northwest, Atlanta, Georgia 30309, (404) 347-7632.

David Scozzafave, Eastern Regional Coordinator, Forest Service, 626 East Wisconsin Avenue, Milwaukee, Wisconsin 53202, (414) 297-3602.

Bobbie Jo Skibo, Alaska Regional Coordinator, Forest Service, 709 West 9th Street, Room 561C, Juneau, Alaska 99801-1807, (907) 441-1539.

Equal opportunity practices in accordance with USDA policies shall be followed in all appointments to the Panel. To ensure that the recommendations of the Panel have taken into account the needs of the diverse groups served by USDA, membership will, to the extent practicable, include individuals with demonstrated ability to represent all racial and ethnic groups, women and men, and persons with disabilities.

Background

On July 22, 2008, Commerce published the AD and CVD orders on CWP from China. 1 On November 1, 2018, Commerce initiated  2 and the ITC instituted  3 five-year (“sunset”) reviews of the AD and CVD orders on CWP from China, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). As a result of its reviews, Commerce determined, pursuant to sections 751(c)(1) and 752(b) and (c) of the Act, that revocation of the CVD Order on CWP from China would be likely to lead to continuation or recurrence of countervailable subsidies and notified the ITC of the magnitude of the subsidy rates likely to prevail were the order revoked, 4 and Commerce determined that revocation of the AD Order on CWP from China would likely lead to continuation or recurrence of dumping and notified the ITC of the magnitude of the margins of dumping likely to prevail were the order revoked. 5

On June 19, 2019, the ITC published its determinations, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the Orders would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 6

The scope of these orders covers certain welded carbon quality steel pipes and tubes, of circular cross-section, and with an outside diameter of 0.372 inches (9.45 mm) or more, but not more than 16 inches (406.4 mm), whether or not stenciled, regardless of wall thickness, surface finish ( e.g., black, galvanized, or painted), end finish ( e.g., plain end, beveled end, grooved, threaded, or threaded and coupled), or industry specification ( e.g., ASTM, proprietary, or other), generally known as standard pipe and structural pipe (they may also be referred to as circular, structural, or mechanical tubing).

Specifically, the term “carbon quality” includes products in which (a) iron predominates, by weight, over each of the other contained elements; (b) the carbon content is 2 percent or less, by weight; and (c) none of the elements listed below exceeds the quantity, by weight, as indicated:

(i) 1.80 percent of manganese;

(ii) 2.25 percent of silicon;

(iii) 1.00 percent of copper;

(iv) 0.50 percent of aluminum;

(v) 1.25 percent of chromium;

(vi) 0.30 percent of cobalt;

(vii) 0.40 percent of lead;

(viii) 1.25 percent of nickel;

(ix) 0.30 percent of tungsten;

(x) 0.15 percent of molybdenum;

(xi) 0.10 percent of niobium;

(xii) 0.41 percent of titanium;

(xiii) 0.15 percent of vanadium; or

(xiv) 0.15 percent of zirconium.

Standard pipe is made primarily to American Society for Testing and Materials (ASTM) specifications, but can be made to other specifications. Standard pipe is made primarily to ASTM specifications A-53, A-135, and A-795. Structural pipe is made primarily to ASTM specifications A-252 and A-500. Standard and structural pipe may also be produced to proprietary specifications rather than to industry specifications. This is often the case, for example, with fence tubing. Pipe multiple-stenciled to a standard and/or structural specification and to any other specification, such as the American Petroleum Institute (API) API-5L specification, is also covered by the scope of these orders when it meets the physical description set forth above and also has one or more of the following characteristics: Is 32 feet in length or less; is less than 2.0 inches (50 mm) in outside diameter; has a galvanized and/or painted surface finish; or has a threaded and/or coupled end finish. (The term “painted” does not include coatings to inhibit rust in transit, such as varnish, but includes coatings such as polyester.)

The scope of these orders does not include: (a) Pipe suitable for use in boilers, superheaters, heat exchangers, condensers, refining furnaces and feedwater heaters, whether or not cold drawn; (b) mechanical tubing, whether or not cold-drawn; (c) finished electrical conduit; (d) finished scaffolding; (e) tube and pipe hollows for redrawing; (f) oil country tubular goods produced to API specifications; and (g) line pipe produced to only API specifications.

The pipe products that are the subject of these orders are currently classifiable in HTSUS statistical reporting numbers 7306.30.10.00, 7306.30.50.25, 7306.30.50.32, 7306.30.50.40, 7306.30.50.55, 7306.30.50.85, 7306.30.50.90, 7306.50.10.00, 7306.50.50.50, 7306.50.50.70, 7306.19.10.10, 7306.19.10.50, 7306.19.51.10, and 7306.19.51.50. However, the product description, and not the Harmonized Tariff Schedule of the United States (HTSUS) classification, is dispositive of whether merchandise imported into the United States falls within the scope of the orders.

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to a continuation or a recurrence of dumping, countervailable subsidies, and of material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), Commerce hereby orders the continuation of the Orders . U.S. Customs and Border Protection (CBP) will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of the Orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year review of the Orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Failure to comply is a violation of the APO which may be subject to sanctions.

These five-year (sunset) reviews and this notice are in accordance with sections 751(c) and (d)(2) of the Act, and published in accordance with section 777(i) of the Act and 19 CFR 351.218(f)(4).

On February 14, 2005, NMFS received a request from the Makah Indian Tribe for a waiver of the MMPA moratorium on the take of marine mammals to allow for take of ENP gray whales ( Eschrichtius robustus ). The Tribe requested that NMFS authorize a tribal hunt for ENP gray whales in the coastal portion of the Tribe's usual and accustomed fishing area for ceremonial and subsistence purposes and the making and sale of handicrafts. The MMPA imposes a general moratorium on the taking of marine mammals but authorizes the Secretary of Commerce to waive the moratorium and issue regulations governing the take if certain statutory criteria are met.

On April 5, 2019, NMFS published a Notice of Hearing and the associated proposed regulations in the Federal Register (84 FR 13639 and 84 FR 13604). Pursuant to an interagency agreement, a Coast Guard Administrative Law Judge was assigned to conduct the formal hearing and issue a recommended decision in this matter under the procedures set forth at 50 CFR part 228.

A prehearing conference took place on June 17, 2019 at the Jackson Federal Building, Seattle, WA. In compliance with 50 CFR 228.12, Judge George J. Jordan issued the following notice of final agenda for publication in the Federal Register .

A. Did NMFS give due regard to the distribution, abundance, breeding habits, and times and lines of migratory movements of the stock subject to the waiver? Will the proposed waiver have a meaningful effect on the distribution, abundance, breeding habits, or migratory movements of the stock subject to the waiver?

1. Distribution and Abundance:

a. What numbers are appropriate to use for ENP, WNP, and PCFG:

b. What are the maximum number of ENP and PCFG whale deaths and maximum percentage reduction in ENP and PCFG abundance expected to result from Makah hunting over the 10-year waiver period?

i. Would this reduction have any impact on ENP or PCFG abundance?

c. Is the ENP stock currently undergoing an Unusual Mortality Event (UME)? If so, does this merit further consideration before a waiver may be granted?

d. Is the carrying capacity of ENP stock in the summer feeding areas being reduced and does this merit further consideration before a waiver may be granted?

2. Facts pertaining to Breeding Habits:

a. Under the proposed waiver, will hunting or hunt training overlap with the breeding season? Will this most likely occur in December-January?

i. What is the expected frequency of hunt activities during the relevant time period?

ii. Will the boundaries set for the proposed hunt adversely affect mating whales or mothers and calves?

3. Facts pertaining to Time and Lines of Migratory Movements:

a. Does the majority of the ENP stock range from the winter/spring breeding grounds in northern Mexico and southern California to the summer/fall feeding grounds in the Bering, Beaufort, and Chukchi seas? Should the Okhotsk Sea be included in the migratory range?

b. Does the ENP stock migrate between the breeding and feeding grounds between December and May?

i. Is the timing of the southbound migration being altered due to a longer feeding season in the Arctic?

c. Will migrating ENP whales generally be encountered only during even-year hunts?

i. How long is it expected to take for a migrating ENP whale to pass through the proposed hunt boundary?

ii. Proportionally, how much of the migratory range is included in the proposed hunt boundary?

iii. What is the expected range and duration of hunting activities during the even-year hunts?

iv. How many whales are likely to be subjected to hunt or training activities?

d. Does the PCFG spend the summer and fall feeding season off the Pacific coast of North America from northern California to northern Vancouver Island? Are some PCFG whales also present in the feeding area throughout the winter?

i. Are PCFG whales expected to be encountered during both even-and odd-year hunts?

ii. Is the PCFG further delineated into sub-groups with distinct feeding areas? Do PCFG whales randomly choose feeding areas or are they internally or externally recruited into sub-groups?

iii. Will the proposed waiver have a disproportionate impact on PCFG whales in the Makah Tribe's Usual and Accustomed (U&A) hunting area? Particularly, will it have an impact on reproductive females?

e. Will non-lethal hunting activities result in a lasting effect on ENP/PCFG migratory movements?

B. Are NMFS's Determinations Consistent with the MMPA's Purposes and Policies?

1. Facts pertaining to the Health and Stability of the Marine Ecosystem and Functioning of Marine Mammals within their Ecosystems.

a. Is the northern California Current ecosystem the appropriate ecosystem to focus on for this proceeding? Should the focus instead be on a smaller biologically relevant scale such as the northern Washington coastal environment or an even more localized area such as the Makah U&A?

b. What effect would the waiver have on the relevant ecosystem(s) or area(s)?

i. What role do gray whales play in structuring the relevant ecosystem? Does this differ in the various geographical areas in which gray whales are present?

ii. In light of NMFS's assertion that “most effects of the hunt would be temporary and localized,” does the environmental role and impact of the small groups of whales feeding in the Makah U&A necessitate separate consideration under the MMPA?

iii. Would the level of hunting proposed affect only a small fraction of the ENP stock and the stock's ecosystems? Should the effects on ENP stock as a whole be compared and contrasted to the effects on the PCFG subset?

c. How do non-lethal activities such as training approaches and training harpoon throws affect whale health and behavior?

d. Consideration of waiver's collateral effects on WNP stock

i. Do WNP whales occasionally migrate along with ENP whales to the North American breeding grounds, or are these whales in fact a Western Feeding Group (WFG) of the ENP stock?

ii. If WNP whales are present in the ENP migration, how many are expected? Is this number constant or does it fluctuate?

iii. What is the appropriate calculation for the likelihood that a WNP whale will be approached, struck, or killed?

iv. Given that the waiver only applies to ENP stock, will an incidental take permit be required under the Endangered Species Act (ESA) to account for the possibility of a WNP whale being taken?

v. Should struck or lost whales that cannot be identified as ENP stock be considered to be WNP whales rather than PCFG whales?

2. Facts pertaining to Stocks to Attaining or Maintaining Optimum Sustainable Population (OSP) Levels

a. Is NMFS's conclusion that ENP stock are within OSP levels, at 85 percent carrying capacity, and with an 88 percent likelihood that the stock is above its maximum net productivity level scientifically valid?

i. Does this account for the possibility of an Unusual Mortality Event as discussed in section I.A.1.c., above?

ii. Will the removal of whales pursuant to this waiver affect these calculations?

b. Regardless of whether the PCFG is properly considered a separate stock or a subset of the ENP stock, should an OSP be separately determined for this group of whales?

c. What are the effects on the OSP of WNP whales if a WNP whale is killed?

A. Did NMFS Consider all Enumerated Factors in Prescribing Regulations?

1. Facts pertaining to the effect of regulations on existing and future levels of marine mammal species and population stocks (16 U.S.C. 1373(b)(1)):

a. Many issues related to this factor are discussed in Section I, pertaining to the Requirements for Waiver.

b. Are the protections in the waiver, such as reduced strike and landing limits, new strike limits for PCFG whales and PCFG females, minimum abundance threshold for PCFG whales, photographic and genetic matching, restrictions on additional strikes, restriction of the hunt to U&A waters, 10-year sunset provision sufficiently protective?

c. Are the protections for WNP whales sufficient and appropriate, including alternating hunt seasons, a limit of three strikes during even-year hunts, a ban on hunting during November and June, seasonal restriction on training harpoon throws in odd-numbered years, restriction on multiple strikes within 24 hours in even-year hunts, and the requirement that if a WNP is confirmed to be struck, the hunt will cease until steps are taken to ensure such an event will not recur?

2. Facts pertaining to existing international treaty and agreement obligations of the United States (16 U.S.C. 1373(b)(2)):

a. What is the relevance in this proceeding of the Treaty of Neah Bay, between the Makah Tribe and the United States, which explicitly protects the tribe's right to hunt whales?

b. The United States is a signatory to the International Convention for the Regulation of Whaling (ICRW). The ICRW establishes the International Whaling Commission (IWC), which sets catch limits for aboriginal subsistence whaling.

i. Since 1997, the IWC has routinely approved an aboriginal subsistence catch limit for ENP gray whales for joint use by the United States and the Russian Federation.

ii. The United States and the Russian Federation have been routinely, and are currently, parties to a bilateral agreement that allocates the IWC catch limit between the two countries and allows either country to transfer to the other any unused allocation.

iii. The IWC gray whale catch limit is currently 140 per year, with 5 gray whales per year allocated to the United States.

iv. If the waiver at issue here is not approved, will the United States continue to transfer the unused portion of the gray whale catch limit to the Russian Federation for use by Chukotkan natives, as has been current practice?

v. Does the proposed hunt comply with the IWC conservation objectives for WNP, ENP, and PCFG whales?

vi. Is the proposed hunt an aboriginal substance hunt as defined by the IWC?

A. Is the entire constellation of activities involved in hunting whales integral to the Makah Tribe?

B. How central is whaling to Makah Tribal identity? Does the Tribe have a continuing traditional dependence?

C. Does the Makah Tribe have a nutritional, substance, and cultural need for whaling?

D. Is any traditional dependence on whaling obviated by the Makah Tribe's engagement in sealing starting in the latter half of the 19th century and the near-cessation of whale hunting after 1927?

E. Is it possible for the Makah Tribe to substitute other, non-lethal activities and maintain their traditional ties to whaling?

3. Facts pertaining to the marine ecosystem and related environmental considerations (16 U.S.C. 1373(b)(3)):

a. Is NMFS's risk analysis sufficiently conservative and based on the best available scientific evidence?

b. Is consideration of cumulative impacts, including those including those from military exercises, marine energy and coastal development, and climate change, necessary? If so, is there evidence these factors were considered?

c. Were all local impacts that must be considered under the MMPA adequately considered?

4. Facts pertaining to the conservation, development, and utilization of fishery resources (16 U.S.C. 1373(b)(4)):

a. NMFS asserts the proposed hunt will have no effect on the conservation, development, and utilization of fishery resources.

5. Facts pertaining to the economic and technological feasibility of implementation (16 U.S.C. 1373(b)(5)):

a. What are the specific costs to NMFS and to the Makah Tribe associated with regulating a hunt under the proposed regulations? Are these feasible?

b. What are the specific technological requirements associated with managing and carrying out a hunt? Are these feasible?

c. What are the costs of enforcing the various restrictions contained in the regulations? Are these feasible?

d. Who is specifically tasked with each type of enforcement ( i.e. , training restrictions, strike restrictions, use and sale restrictions on edible and non-edible whale parts) and do those persons/organizations have the necessary training and authority to carry out their obligations?

e. How will records be kept and shared amongst the necessary parties? How will any discrepancies in the records be resolved?

f. Is the use of photo-identification technology economically and technologically feasible? How quickly can identification be made? Is genetic identification more scientifically reliable and how does its economic and technological feasibility compare?

6. Other factors not enumerated in 16 U.S.C. 1373(b), but raised by parties to this proceeding and meriting consideration:

a. What is the appropriate degree to which the analysis in Anderson v. Evans, 371 F.3d 475 (9th Cir. 2011) should be considered in this proceeding?

b. Are the definitions contained in the proposed regulations adequate or do they contain ambiguities, omissions, and/or inconsistencies?

B. Restrictions in the Proposed Regulations.

1. Issues pertaining to the proposed restrictions on the number of animals that may be taken in any calendar year (16 U.S.C. 1373(c)(1)):

a. Hunt permits may authorize no more than three gray whales to be landed in an even-year hunt and no more than one to be landed in an odd-year hunt. No more than three strikes are permitted during an even-year hunt and no more than two are permitted in an odd-year hunt.

b. Additional restrictions are placed on the taking of PCFG whales and WNP whales.

c. How were the low-abundance triggers for PCFG whales, which would cause hunting activity to cease, determined?

2. Issues pertaining to the proposed restrictions on the age, size, sex, or any combination thereof of animals that may be taken (16 U.S.C. 1373(c)(2)):

a. Are the limits set on authorized strikes of PCFG females appropriate?

b. Are there, or should there be, limitations on approaches or strikes on calves or mother-and-calf pairs?

3. Issues pertaining to the season or other period of time within which animals may be taken (16 U.S.C. 1373(c)(3)):

a. The hunting seasons are split into “even-year hunts,” during which hunting would be authorized from December 1 of an odd-numbered year until May 31 of the following even-numbered year, and “odd-year hunts,” during which hunting would be authorized from July 1 through October 31 of the odd-numbered year.

4. Issues pertaining to the manner and locations in which animals may be taken (16 U.S.C. 1373(c)(4)):

a. The proposed waiver and regulations authorize training exercises, including approaches and training harpoon throws. A question has been raised as to whether the inclusion of training exercises is necessary and/or appropriate.

b. Do the definitions of “land” and “landing” provide sufficient information about where the Makah Tribe would be permitted to land whales? Are consultations with other Federal and state agencies necessary (see 16 U.S.C. 1382)?

c. Are the definitions of “strike” and “struck” ambiguous? Specifically, issues have been raised regarding the single-strike limit within 24 hours (whether a harpoon strike followed by a firearm shot consist of a single “strike” or two separate strikes, and whether this will lead to unnecessary suffering on the part of a whale that is struck but not immediately killed); whether whales can be appropriately identified as belonging to WNP stock, ENP stock, or the PCFG during a 24-hour post-strike period; whether the use of crossbows or other devices to obtain genetic material from a struck whale should also be considered a strike; and whether the struck-and-lost limits proposed are inconsistent with the definition of “strike.”

d. Will independent observers be present at every hunt or only certain hunts? How are these observers selected and trained?

e. Should the potential for an off-shore hunt to result in the taking of more migratory ENP whales and fewer PCFG/Makah U&A whales be considered?

5. Issues pertaining to techniques which have been found to cause undue fatalities to any species of marine mammal (16 U.S.C. 1373(c)(5)):

a. None identified.

6. Issues related to other proposed restrictions not specifically enumerated in 16 U.S.C. 1373(c):

a. Restrictions on the use or sale of gray whale products:

i. Do the restrictions on utilization of edible products of ENP gray whales off-reservation unfairly burden enrolled Makah Tribe members living elsewhere? Are such members permitted to share ENP gray whale products with members of their immediate households who are not enrolled in the Makah Tribe?

ii. Are there any restrictions on the resale of handicrafts by persons who are not enrolled members of the Makah tribe, either on a small or large scale?

iii. Are there restrictions on the international sale or transportation of handicrafts?

During the prehearing conference, the participants stipulated that, while discussion of issues related to the hunt methodology and humaneness during the hearing are not entirely foreclosed, this hearing is not the appropriate time for the final determination of these issues; rather, they will be determined during the permitting process.

The parties also agreed that, while evidence concerning the waiver's impact on various stocks and populations of gray whales recognized or supported by the scientific literature may be considered, the parties will not challenge the identification of any whale populations, stocks, or groups under the MMPA during this hearing.

The parties have submitted the following direct testimony which bears on the issues noted above:

The parties have identified the following witnesses, who will be cross-examined regarding their direct testimony. Potential rebuttal witnesses have not yet been identified.

The following issue was not included in the notice of hearing published on April 5, 2019 (84 FR 13639): Is the ENP stock currently undergoing an Unusual Mortality Event (UME)? If so, does this merit further consideration before a waiver may be granted?

Any person desiring to participate as a party at the hearing on the new issue of fact must file a notice of intent to participate with the NMFS West Coast Region Regional Administrator by certified mail, postmarked no later than July 8, 2019, as described in the DATES and ADDRESSES sections above.

The hearing on this matter is currently scheduled to begin on August 12, 2019 in the Jackson Federal Building, Seattle, WA. At the pre-hearing conference, several parties requested a change in the date of the proceeding due to issues concerning the availability of witnesses and counsel. The parties are briefing the presiding officer on this issue. If the presiding officer reschedules the hearing, a notice will be published in the Federal Register .

The presiding officer, Judge George J. Jordan, prepared the contents of this notice. A copy of the draft notice Judge Jordan submitted to the NMFS Regulations Unit for filing with the Office of the Federal Register (OFR) was made available to all parties to this proceeding. The NMFS Regulations Unit reviewed the notice to ensure consistency with the OFR filing requirements. NMFS was otherwise not involved in the review of the contents of the notice. The signature of NMFS West Coast Regional Administrator Barry Thom is required to authorize the filing of the notice with the OFR.

The subject amendment to Permit No. 20430 is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

Permit No. 20430, issued on March 30, 2017 (82 FR 29053), authorizes the permit holder to conduct research on 12 species of marine mammals in California waters to study their distribution, movement, diet, foraging, and acoustic behaviors. Permitted research activities include passive acoustic recordings, behavioral observations, photography, photo-identification, videography, biological sampling (skin and blubber biopsy or sloughed skin), tagging (suction cup or dart/barb), and tracking. Additionally, a small number of non-target marine mammals may be incidentally harassed during research.

The permit holder is requesting the permit be amended to (1) authorize aerial surveys by unmanned aircraft systems (UAS) for photography, video recording, and photogrammetry for a new research objective to determine morphometric measurements to better understand reproductive health, growth rates, maneuverability, and energy capacity; (2) increase the number of takes for humpback whales ( Megaptera novaeangliae ) to 500 Level B harassment takes, 50 suction-cup tags, and 35 dart/barb tags, annually, due to their increased presence in the research area; and (3) increase the number of incidental disturbance takes for California sea lions ( Zalophus californianus ) to 1,000 individuals, annually.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of this application to the Marine Mammal Commission and its Committee of Scientific Advisors.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq. ).

The applicant requests a five-year permit to assess the biology and ecology of cetaceans in U.S. and international waters along the U.S. west coast south to the Baja California Peninsula, Hawaii and Alaska. The main research objectives are to investigate cetacean (1) distribution, abundance, stock structure, habitat use and demographics, (2) behavioral ecology, (3) population health and exposure to potential stressors, and (4) behavioral responses to military sound sources. Research would be conducted from vessel and aerial platforms (manned and unmanned aircraft systems), for: Counts, sample collection (prey remains, fecal, sloughed skin, skin and blubber biopsy, breath), observations, acoustic recordings, acoustic playbacks, photo-identification, videography, photogrammetry, tagging and tracking. Researchers may incidentally disturb seven pinniped species, including the endangered Western DPS of Steller sea lion ( Eumetopias jubatus ) and Hawaiian monk seals ( Neomonachus schauinslandi ), during studies. Biological samples collected in international waters may be imported and re-exported. See the application for take numbers requested.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

This notice solicits comments on the collections of information mandated by Commission regulations 23.600 (Risk Management Program), 23.601 (Monitoring of Position Limits), 23.602 (Diligent Supervision), 23.603 (Business Continuity and Disaster Recovery) 23.606 (General Information: Availability for Disclosure and Inspection), and 23.607 (Antitrust Considerations).

Title: Regulations Establishing and Governing the Duties of Swap Dealers and Major Swap Participants (OMB Control No. 3038-0084). This is a request for an extension and revision of a currently approved information collection.

Abstract: On April 3, 2012 the Commission adopted Commission regulations 23.600 (Risk Management Program), 23.601 (Monitoring of Position Limits), 23.602 (Diligent Supervision), 23.603 (Business Continuity and Disaster Recovery), 23.606 (General Information: Availability for Disclosure and Inspection), and 23.607 (Antitrust Considerations)  2 pursuant to section 4s(j)  3 of the Commodity Exchange Act (CEA). These regulations adopted by the Commission require, among other things, swap dealers (SD)  4 and major swap participants (MSP)  5 to develop a risk management program (including a plan for business continuity and disaster recovery and policies and procedures designed to ensure compliance with applicable position limits). The Commission believes that the information collection obligations imposed by these regulations are essential to ensuring that swap dealers and major swap participants maintain adequate and effective risk management programs and policies and procedures to ensure compliance with position limits. On April 10, 2019, the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 84 FR 14350, (“60-Day Notice”). The Commission did not receive any comments on the 60-Day Notice.

Burden Statement: The Commission is revising its estimate of the burden for this collection to reflect the current number of respondents and estimated burden hours. The respondent burden for this collection is estimated to be as follows:

Number of Registrants: 103.

Estimated Average Burden Hours per Registrant: 1,148.5.

Estimated Aggregate Burden Hours: 118,295.5.

Frequency of Recordkeeping: As applicable.

There are no capital costs or operating and maintenance costs associated with this collection.

Title: Regulations and Forms Pertaining to the Financial Integrity of the Marketplace (OMB Control No. 3038-0024). This is a request for extension of a currently approved information collection.

Abstract: The Commission is the independent federal regulatory agency charged with providing various forms of customer protection so that users of the commodity markets can be assured of the financial integrity of the markets and the intermediaries that they employ in their trading activities. Part 1 of the Commission's regulations requires, among other things, that commodity brokers—known as futures commission merchants (FCM) or introducing brokers (IB) comply with minimum capital and segregation requirements. In order to monitor compliance with these financial standards, the Commission has required FCMs and IBs to file financial reports with the Commission and with the designated self-regulatory organization (DSRO) of which they are members as well as to report to the Commission should capital levels drop below prescribed minimums.

In 2008, the U.S. Congress passed the Food, Conservation, and Energy Act of 2008, Public Law 110-246, 122 Stat. 1651, 2189-2204 (2008), also known as the Farm Bill. The Farm Bill provided the Commission with new authority with regard to the regulation of off-exchange retail forex transactions. Among other things, it directed the Commission to draft rules effectuating registration provisions for a new category of registrant—the retail foreign exchange dealer, or RFED. Under the terms of the legislation, RFEDs are subject to the same capital requirements as FCMs that are engaged in retail forex transactions, and, therefore, subject to the same reporting requirements. Accordingly, this collection was amended to reflect the financial reporting requirements of the new category of registrant, RFEDs.

In 2010, the U.S. Congress passed the Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”), Public Law 111-203, 124 Stat. 1376 (2010), giving the Commission the authority to regulate certain swap markets and participants in those markets. Section 731 of the Dodd-Frank Act, amended the Commodity Exchange Act (CEA), 7 U.S.C. 1 et seq., to add, as section 4s(e) thereof, provisions concerning the setting of initial and variation margin requirements for swap dealers (SD) and major swap participants (MSP). In 2016, the Commission finalized the Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants rule to implement those requirements. Specifically, Regulation 23.154(b) require SDs and MSPs that do not have a prudential regulator (CSE) that are using a model to compute initial margin requirements to submit the model for review and approval by the Commission or a registered futures association. CSEs must also notify the Commission upon making certain changes to the model. The information required for the prior written approval of the margin model or for certain changes to such model, is needed to demonstrate that the model satisfies all of the requirements of Regulation 23.154(b).

Finally, in 2013, the Commission finalized rules in an effort to prevent unauthorized usage of customer funds by FCMs and RFEDs. The final rules include modifications to the reporting requirements required by the Commission which resulted in changes to the financial statements filed by FCMs and RFEDs and made some of the recordkeeping requirements already contained in this OMB Collection Number 3038-0024 into reporting requirements. These rules added additional recordkeeping requirements by FCMs to assure the segregation of customer funds. This collection, OMB Control No. 3038-0024, is needed for the Commission to continue its financial monitoring of its registrants. The burden hours are being revised to reflect the current number of registrants and updated to reflect more accurate numbers regarding the number of financial reports filed, based on current historical data.

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. On April 9, 2019, the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 84 FR 14099 (“60-Day Notice”). The Commission did not receive any comments on the 60-Day Notice.

Burden Statement: The Commission is revising its estimate of the burden for this collection for approximately 66 FCMs and RFEDs, 50 CSEs and 1,178 IBs. The respondent burden for this collection is estimated to be as follows:

Respondents/Affected Entities: FCMs, RFEDs, IBs, SDs, and MSPs that do not have a Prudential Regulator.

Estimated Number of Respondents: 1,294.

Estimated Average Burden Hours per Respondent: 62.

Estimated Total Annual Burden Hours: 80,837.

Frequency of Collection: Various. For example, FCMs have both daily and monthly financial reporting obligations, annual certified financial and compliance report obligations, and periodic notice requirements.

There are no capital costs or operating and maintenance costs associated with this collection.

Title: Core Principles and Other Requirements for Designated Contract Markets (OMB Control No. 3038-0052). This is a request for a revision of a currently approved information collection.

Abstract: The Commission has recently amended its Regulation 1.52 to revise the scope and potential frequency of a third-party expert's evaluation of self-regulatory organizations' (SRO) financial surveillance programs. The evaluation report requirement is a portion of the existing information collection of requirements for SROs under Commission Regulation 1.52, including designated contract markets (DCM) and the National Futures Association. The Commission's rulemaking will not alter the requirement for an SRO to engage an examinations expert to evaluate its supervisory program prior to the initial use of the supervisory program. The Commission, however, is eliminating the requirement that the examinations expert must review the SRO's ongoing application of its supervisory program during periodic reviews and the analysis of the supervisory program's design to detect material weaknesses in internal controls during both periodic reviews and the initial review prior to the program's initial use. The Commission also is revising the frequency of when an SRO must engage an examinations expert. Regulation 1.52 required an SRO to engage an examinations expert at least once every three years to perform such a review. The Commission amended Regulation 1.52 to require an SRO to engage an examinations expert whenever the Public Company Accounting Oversight Board (PCAOB) issues new or revised auditing standards that are material to the SRO's examination of member futures commission merchants (FCM). The amendments further require an SRO to engage an examinations expert at least once every five years even if the SRO determined that the PCAOB did not issue new or revised auditing standards during the previous five-year period that are material to its examinations of member FCMs. The changes to the examinations expert reviews impact the resulting expert reports information collection burden. The information collection is necessary to enhance the ability of the Commission and the designated SRO to identify problematic financial matters in time to avoid market disruptions when an FCM may fail, particularly with respect to the tie-up of customer funds that may result.

The Commission, when originally proposing changes to Regulation 1.52, invited comments on its assessment that although the costs associated with obtaining the third-party expert would be reduced by the amendment, the paperwork burden impact of the amended scope of the report would be minimal. The Commission received no comments and has adopted the final rule. However, the Commission has determined that a slight revision of the expected burden hours associated with the information collection is possible due to the changes related to the third-party examinations expert report. Accordingly, the Commission is revising the total burden hours related to Regulation 1.52 included in this collection.

The Commission previously estimated the entire burden hours for DCMs as SROs associated with Regulation 1.52 as 50 hours per respondent. The revised scope of the third-party evaluation report should slightly reduce personnel hours needed to coordinate obtaining the report, although most of the burden hours included in this collection are associated with other aspects of the financial surveillance program requirements. Therefore, the Commission is revising the estimate of the burden hours associated with Regulation 1.52 to be 49 hours per respondent. Additionally, the Commission notes that the number of registered, active DCMs has decreased from 15 to 14.

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. On April 3, 2019 the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 84 FR 13008 (“60-Day Notice”). The Commission did not receive any relevant comments on the 60-Day Notice.

Burden Statement: The Commission is revising its estimate of the burden for this collection. 2 The respondent burden for this collection is estimated to be as follows:

Respondents/Affected Entities: Designated Contract Markets and Self-regulatory Organizations.

Estimated Number of Respondents: 14.

Estimated Average Burden Hours per Respondent: 49.

Estimated Total Annual Burden Hours: 686.

Frequency of Collection: Various.

The amended regulations require no new startup or operations and maintenance costs.

Draft National Environmental Policy Act Guidance on Consideration of Greenhouse Gas Emissions I. Introduction

The Council on Environmental Quality (CEQ) provides this draft guidance memorandum  1 to assist Federal agencies in their consideration of greenhouse gas (GHG) emissions  2 when evaluating proposed major Federal actions in accordance with the National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., and the CEQ Regulations for Implementing the Procedural Provisions of NEPA, 40 CFR parts 1500-1508 (“CEQ Regulations”). The purpose of this draft guidance is to facilitate compliance with NEPA by Federal agencies conducting reviews of proposed major Federal actions. 3

NEPA requires that Federal agencies study the environmental impacts of major Federal actions significantly affecting the quality of the human environment. 42 U.S.C. 4332(2)(C). NEPA is a procedural statute that serves the twin purposes of ensuring that agencies consider the environmental consequences of their proposed actions and inform the public about their decision-making process. Agencies should analyze reasonably foreseeable environmental consequences of major Federal actions, but should not consider those that are remote or speculative. 40 CFR 1508.8.

Under CEQ regulations and the “rule of reason” that bounds all NEPA analysis, impacts of a proposed action should be discussed in proportion to their significance, and there should only be brief discussion of issues that are not significant. 4 As with all NEPA analyses, the rule of reason permits agencies to use their expertise and experience to decide how and to what degree to analyze particular effects. Agencies preparing NEPA analyses need not give greater consideration to potential effects from GHG emissions than to other potential effects on the human environment.

A projection of a proposed action's direct and reasonably foreseeable indirect GHG emissions may be used as a proxy for assessing potential climate effects. Direct effects are caused by the action and occur at the same time or place. 40 CFR 1508.8(a). Indirect effects are caused by the action and are later in time or farther removed in distance, but are still reasonably foreseeable. 40 CFR 1508.8(b). Following the rule of reason, agencies should assess effects when a sufficiently close causal relationship exists between the proposed action and the effect. A “but for” causal relationship is not sufficient.

Agencies should attempt to quantify a proposed action's projected direct and reasonably foreseeable indirect GHG emissions when the amount of those emissions is substantial enough to warrant quantification, and when it is practicable to quantify them using available data and GHG quantification tools. 5 Agencies should consider whether quantifying a proposed action's projected reasonably foreseeable GHG emissions would be practicable and whether quantification would be overly speculative. If an agency concludes that quantification would not be practicable or would be overly speculative, it should explain its decision.

Where GHG inventory information is available, an agency may also reference local, regional, national, or sector-wide emission estimates to provide context for understanding the relative magnitude of a proposed action's GHG emissions. This approach, together with a qualitative summary discussion of the effects of GHG emissions based on an appropriate literature review, allows an agency to present the environmental impacts of a proposed action in clear terms and with sufficient information to make a reasoned choice among the alternatives. Such a discussion satisfies NEPA's requirement that agencies analyze the cumulative effects of a proposed action because the potential effects of GHG emissions are inherently a global cumulative effect. Therefore, a separate cumulative effects analysis is not required.

When an agency determines that the tools, methods, or data inputs necessary to quantify a proposed action's GHG emissions are not reasonably available, or it otherwise would not be practicable, the agency should include a qualitative analysis and explain its basis for determining that quantification is not warranted. Agencies are not required to quantify effects where information necessary for quantification is unavailable, not of high quality, or the complexity of identifying emissions would make quantification overly speculative. 40 CFR 1502.22. A qualitative analysis may rely on sector-specific descriptions of the GHG emissions for the category of Federal action that is the subject of the NEPA analysis. Agencies need not undertake new research or analysis of potential climate effects and may rely on available information and relevant scientific literature.

In their NEPA analyses, agencies should consider reasonable alternatives to the proposed action and discuss the short- and long-term effects and benefits of those alternatives. 40 CFR 1502.14 and 1508.9(b). NEPA does not require agencies to adopt mitigation measures. However, comparing alternatives based on potential effects due to GHG emissions, along with other potential effects and economic and technical considerations, can help agencies differentiate among alternatives. 40 CFR 1502.14 and 1502.16(e).

Consideration of effects on the quality of the human environment due to GHG emissions does not require agencies to expand the range of Federal agency actions subject to NEPA or develop new NEPA implementing procedures. As required by CEQ regulations, agencies shall conduct NEPA analyses based on current scientific information and methods to the extent reasonably available and practicable. 40 CFR 1500.1(b), 1502.22, and 1502.24. In preparing their NEPA analyses, agencies can incorporate by reference pre-existing plans, inventories, reviews, assessments, and research whenever appropriate. Agencies may also use programmatic analyses, programmatic approaches, and tiering to address emission considerations (including GHG emissions) that are relevant to the stage of decisionmaking for the proposed action.

Analyses under NEPA should include a description of the affected environment to provide a basis for comparing the current and the reasonably foreseeable future state of the environment as affected by the proposed action and its reasonable alternatives. When relevant, agencies should consider whether the proposed action would be affected by foreseeable changes to the affected environment under a reasonable scenario. In accordance with NEPA's rule of reason and standards for obtaining information regarding reasonably foreseeable effects on the human environment, agencies need not undertake new research or analysis of potential changes to the affected environment in the proposed action area and may summarize and incorporate by reference appropriate scientific literature. 40 CFR 1502.21 and 1502.24.

NEPA and CEQ's implementing regulations do not require agencies to monetize costs and benefits of a proposed action. CEQ regulations provide that agencies need not weigh the merits and drawbacks of particular alternatives in a monetary cost-benefit analysis. 40 CFR 1502.23. 6 For this reason, an agency need not weigh the effects of the various alternatives in NEPA in a monetary cost-benefit analysis using any monetized Social Cost of Carbon (SCC) estimates and related documents (collectively referred to as “SCC estimates”), 7 or other similar cost metrics. 8

Further, the SCC estimates were developed for rulemaking purposes to assist agencies in evaluating the costs and benefits of regulatory actions, and were not intended for socio-economic analysis under NEPA or decision-making on individual actions, including project-level decisions. If an agency does consider costs and benefits that are relevant to the choice among environmentally different alternatives for a proposed action, such as in a rulemaking, the agency should incorporate by reference or append such analyses to the environmental impact statement as an aid in evaluating the environmental consequences. 40 CFR 1502.21 and 1502.23. When using a monetary cost-benefit analysis, just as with tools to quantify emissions, the agency should disclose the assumptions and levels of uncertainty associated with such analysis.

Finally, CEQ's regulations require consideration of “effects,” including “ecological . . ., aesthetic, historic, cultural, economic, social, or health, whether direct, indirect, or cumulative.” 40 CFR 1508.8(b). There may be some effects that are more capable of monetization or quantification, such as employment or other socio-economic impacts, and that the agency may determine are useful to include in its NEPA review. Monetization or quantification of some aspects of an agency's analysis does not require that all effects, including potential effects of GHG emissions, be monetized or quantified. Where an agency decides to quantify some effects but not others, the agency should explain the choices it has made in its analysis.

Consistent with OMB's “Agency Good Guidance Practices” (72 FR 3432, Jan. 25, 2007), the draft guidance document was submitted to OMB for review.

Title; Associated Form; and OMB Number: Department of Defense Consent to Conduct Installation Records Checks (IRC); DD Form 3058; OMB Control Number 0704-XXXX.

Type of Request: New collection.

Number of Respondents: 14,000.

Responses per Respondent: 1.

Annual Responses: 14,000.

Average Burden per Response: 10 minutes.

Annual Burden Hours: 2,333.

Needs and Uses: The information collection requirement is necessary as part of a criminal history background investigation on individual working, volunteering or residing on military installations who come into regular, recurring contact with children under the age of 18 years. The query of records from the installation the Family Advocacy Central Registry and military law enforcement records and the Defense Central Index of Investigations (DCII) will assist the department in obtaining or maintaining an employment suitability or fitness determination for those individuals working with children on military installations. Programs impacted are referenced within the 34 U.S.C. 20351 (Crime Control Act of 1990) and include impacted individuals such as employees, DoD contractors, providers, adults residing in a family child care home, volunteers, and others with regular recurring contact with children.

Affected Public: Individuals or households.

Frequency: As required.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DoD Clearance Officer: Ms. Angela James.

Requests for copies of the information collection proposal should be sent to Ms. James at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: My Career Advanced Account (MyCAA) Scholarship; OMB Control Number 0704-XXXX.

Type of Request: New collection.

Number of Respondents: 10,148.

Responses per Respondent: 3.4.

Annual Responses: 34,503.

Average Burden per Response: 9.4118 minutes.

Annual Burden Hours: 5,412.25.

Needs and Uses: This information collection is necessary to support the MyCAA scholarship program, a career development and employment assistance program intended to assist military spouses pursue licenses, certificates, certifications or associate's degrees necessary for gainful employment in high demand, high growth portable career fields and occupations.

Affected Public: Individuals or households.

Frequency: On occasion.

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

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DoD Clearance Officer: Ms. Angela James.

Requests for copies of the information collection proposal should be sent to Ms. James at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Background and Purpose. Executive Order 11964 of January 19, 1977 and 33 U.S.C. 1605 provide that the requirements of the 72 COLREGS, as to the number, position, range, or arc of visibility of lights or shapes, as well as to the disposition and characteristics of sound-signaling appliances, shall not apply to a vessel or class of vessels of the Navy where the Secretary of the Navy shall find and certify that, by reason of special construction or purpose, it is not possible for such vessel(s) to comply fully with the provisions without interfering with the special function of the vessel(s). Notice of issuance of a Certificate of Alternate Compliance must be made in the Federal Register .

In accordance with 33 U.S.C. 1605, the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, hereby finds and certifies that USS KANSAS CITY (LCS 22) is a vessel of special construction or purpose, and that, with respect to the position of the following navigational lights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS without interfering with the special function of the vessel:

Annex I, paragraph 2(a)(i), pertaining to the vertical position of the forward masthead light; Annex I, paragraph 3(a), pertaining to the horizontal position of the forward masthead light; Rule 21(a) and Annex, paragraph 2(f)(i), pertaining to the arc of visibility of the aft masthead light; Annex I, paragraph 3(a), pertaining to the horizontal separation between the forward and aft masthead lights; Annex I, paragraph 2(f)(ii), pertaining to the horizontal and vertical spacing of the restricted maneuvering task lights; and Rule 27(b)(i) and Annex I, paragraph 9(b), pertaining to the arc of visibility of the restricted maneuvering task lights.

The DAJAG (Admiralty and Maritime Law) further finds and certifies that these navigational lights are in closest possible compliance with the applicable provision of the 72 COLREGS.

Title; Associated Form; and OMB Number: Collection of Personal Information for Casualty Benefits; OPNAV Form 1770/1,“Consent to Release Personal Information”; OPNAV Form 1770/2, “Next of Kin Travel Request”; OPNAV Form 1770/3, “Next of Kin Identification”; OMB Control Number 0703-XXXX.

Needs and Uses: The information is collected from the next of kin (NOK) and other beneficiaries following the death of a Navy Sailor. Basic contact information is passed to members of Congress and the White House (when consent is granted) for use in condolence activity. This and additional information collected is necessary to review, certify, and process payment of benefits awarded to designated NOK and other beneficiaries following the death. The form gathers data necessary to facilitate direct payment of benefits through the Defense Finance and Accounting Agency (DFAS), arrange travel to memorial and funeral services through the Defense Travel System (DTS), and to process travel claims submitted post-travel through DTS to DFAS. Data on the form is used solely for these functions.

Affected Public: Individuals or Households.

Annual Burden Hours: 300.

Number of Respondents: 600.

Responses per Respondent: 1.

Annual Responses: 600.

Average Burden per Response: 30 minutes.

Frequency: As required.

Annual Burden Hours: 400.

Number of Respondents: 800.

Responses per Respondent: 1.

Annual Responses: 800.

Average Burden per Response: 30 minutes.

Frequency: As required.

Annual Burden Hours: 600.

Number of Respondents: 600.

Responses per Respondent: 1.

Annual Responses: 600.

Average Burden per Response: 1 hour.

Frequency: As required.

Total Number of Respondents: 800 (600 will complete all three forms, 200 more will complete form 1770/2).

Total Number of Annual Responses: 800.

Total Respondent Burden Hours: 1300.

Respondents are next of kin (most often spouse and parents) of US Navy Sailors who have died in service to their country. Each case takes approximately 1 hour to complete necessary documentation. The completed form is used solely as described above.

This proposed subsequent arrangement concerns a revision in the decommissioning plan described in an earlier subsequent arrangement—published in the Federal Register May 25, 2011 (76 FR 30326)—for the alteration in form of 28.276 kg (24.541 ekg) of U.S.-origin high enriched uranium (HEU) (26.342 kg U-235) and 0.0048 g of plutonium contained in three irradiated HEU driver fuels. Under the 2011 subsequent arrangement, the United States approved the cutting and de-cladding of the HEU for conversion and downblending to approximately 18% at the Japan Atomic Energy Agency (JAEA) Plutonium Fuel Fabrication Facility, and the temporary storage of the downblended HEU at the JAEA Tokai Plutonium Fuel Production Facility. The downblended HEU was planned for use as fuel for the JAEA experimental fast reactor JOYO. Under the revised plan, the HEU will be cut into segments and de-cladded, then packaged for return to the United States.

Pursuant to the authority in section 131a. of the Atomic Energy Act of 1954, as delegated, I have determined that this proposed subsequent arrangement will not be inimical to the common defense and security of the United States of America.

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 Plastic Parts and Products Surface Coating (40 CFR part 63, subpart PPPP) were proposed on: December 4, 2002; promulgated on April 19, 2004; and amended on April 24, 2007. These regulations apply to both existing and new facilities that perform surface coating of plastic parts and products, and that use at least 100 gallons of HAP-containing coatings annually, and where the potential to emit any single hazardous air pollutant (HAP) is greater than or equal to 10 tons per year, or where the potential to emit any combination of HAPS is greater than or equal to 25 tons per year. 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 PPPP.

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: Existing and new facilities that: Perform surface coating of plastic parts and products and that use at least 100 gallons of HAP-containing coatings annually, and where the potential to emit any single hazardous air pollutant (HAP) is greater than or equal to 10 tons per year, or where the potential to emit any combination of HAPS is greater than or equal to 25 tons per year.

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

Estimated number of respondents: 223 (total).

Frequency of response: Initially and semiannually.

Total estimated burden: 86,400 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $9,910,000 (per year), which includes $66,900 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is an adjustment decrease in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. This decrease is not due to any program changes. The adjustment decrease in burden from the most recently-approved ICR is due to a decrease in the number of existing major sources subject to this rule. The EPA's records indicate that there are currently 223 major sources subject to this NESHAP; the previous estimate of 836 major sources was based on the Final Rule for this NESHAP in 2004. The revised estimate is also supported by preliminary data collected for the NESHAP Risk and Technology Review. This decrease in the estimated number of sources results in decreases in the respondent labor hours, total O&M costs, and number of responses.

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 Pressure Sensitive Tape and Label Surface Coating Operations (40 CFR part 60 subpart RR) were proposed on December 30, 1980, and promulgated on October 18, 1983, and amended on October 17, 2000. These regulations apply to existing facilities and new facilities with coating lines used in the manufacture of pressure sensitive tape and label materials. Existing facilities and new facilities are both subject to these regulations, except those facilities that input 45 mega grams (Mgs) of volatile organic compounds (VOC) or less per 12-month period. 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 60, subpart RR.

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: Coating lines used in the manufacture of pressure sensitive tape and label materials.

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

Estimated number of respondents: 45 (total).

Frequency of response: Initially, occasionally, and semiannually.

Total estimated burden: 4,250 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $572,000 (per year), which includes $88,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is an adjustment increase in the total estimated burden as currently identified in the OMB Inventory of Approved Burden; this increase is not due to any program changes. This increase is due to an increase in the number of respondents based on the assumption that one new respondent per year will be subject to the standard. There is also an adjustment increase in the operating and maintenance costs due to the increase in the number 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 Area Sources: Primary Copper Smelting, Secondary Copper Smelting, and Primary Nonferrous Metals-Zinc, Cadmium, and Beryllium (40 CFR part 63, subparts EEEEEE, FFFFFF, and GGGGGG) were proposed on October 6, 2006, and promulgated on January 23, 2007. These regulations apply to both new and existing primary copper smelting facilities (subpart EEEEEE), new secondary copper smelting facilities (subpart FFFFFF), and both new and existing primary zinc or beryllium production facilities (subpart GGGGGG) that are an area source of hazardous air pollutant (HAP) emissions. 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, subparts EEEEEE, FFFFFF, and GGGGGG.

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: Primary copper smelting facilities, secondary copper smelting facilities, and primary zinc or beryllium production facilities.

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

Estimated number of respondents: Five (total).

Frequency of response: Semiannual.

Total estimated burden: 74 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $8,380 (per year), which includes $0 for annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is no change in the burden in this ICR compared to the previous ICR. This is due to two considerations. First, the regulations have not changed over the past three years and are not anticipated to change over the next three years. Secondly, the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden. There is an adjustment increase in the labor costs in this ICR compared to the previous ICR.

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 Prepared Feeds Manufacturing were proposed on July 27, 2009, promulgated on January 5, 2010, and amended on both July 20, 2010, and December 23, 2011. A prepared feed manufacturing facility is a facility where animal feed (other than feed products for dogs and cats) makes up at least half (by mass) of the facility's annual production of all products. These regulations apply to new and existing area source prepared feeds manufacturing facilities that use one or more materials (additives/premixes) that contain 0.1 percent or greater by weight of chromium (Cr) or 1.0 percent or greater by weight of manganese (Mn). 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 DDDDDDD.

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: Prepared feed manufacturing facilities.

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

Estimated number of respondents: 1,800 (total).

Frequency of response: Annual.

Total estimated burden: 64,100 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $7,350,000 (per year), which includes $37,200 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in the burden in this ICR compared to the previous ICR. This is due to two considerations. First, the regulations have not changed over the past three years and are not anticipated to change over the next three years. Secondly, the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall 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 Clay Ceramics Manufacturing, Glass Manufacturing, and Secondary Nonferrous Metals Processing Area Sources (40 CFR part 63, subparts RRRRRR, SSSSSS, and TTTTTT) were proposed on September 20, 2007, and promulgated on December 26, 2007. These regulations apply to the following existing and new facilities: (1) Clay ceramics manufacturing facilities that process more than 50 tons per year of wet clay and are area sources of hazardous air pollutants (HAP); (2) glass manufacturing facilities that use continuous furnaces to produce glass that contains HAP as raw materials and are area sources of HAP; and (3) secondary nonferrous metals processing facilities that are area sources of HAP. Clay ceramics manufacturing facilities include facilities that manufacture pressed tile, sanitaryware, dinnerware, or pottery with an atomized glaze spray booth or kiln that fires glazed ceramic ware. Glass manufacturing facilities include facilities that manufacture flat glass, glass containers, or pressed and blown glass by melting a mixture of raw materials, to produce molten glass and form the molten glass into sheets, containers, or other shapes. Secondary nonferrous metals processing facilities means brass and bronze ingot making, secondary magnesium processing, or secondary zinc processing plants that use furnace melting operations to melt post-consumer nonferrous metal scrap to make products including bars, ingots, blocks, or metal powders. 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, subparts RRRRRR, SSSSSS, and TTTTTT.

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: Clay ceramics manufacturing facilities that process more than 50 tons per year of wet clay, glass manufacturing facilities that use continuous furnaces to produce glass that contains HAP as raw materials, and secondary nonferrous metals processing facilities that are area sources of HAP.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subparts RRRRRR, SSSSSS, and TTTTTT).

Estimated number of respondents: 82 (total), consisting of 51 clay ceramics manufacturing facilities, 21 glass manufacturing facilities, and 10 secondary nonferrous metals processing facilities.

Frequency of response: Initially and occasionally.

Total estimated burden: 1,950 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $235,000 (per year), which includes $13,200 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an increase in the respondent labor hours in this ICR compared to the previous ICR. The increase is not due to a change in program requirements. The number of respondents expected to refamiliarize with the regulatory requirements each year has been increased to include all 82 respondents. The annual O&M costs for glass furnace inspections have been adjusted upward to reflect current industry labor rates for technical workers. The regulations have not changed over the past three years and are not anticipated to change over the next three years. The growth rate for the industry is very low, negative or non-existent.

This document extends the public comment period established in the Federal Register document of May 6, 2019 (84 FR 19782) (FRL-9992-96). In that document, the Agency announced the availability of EPA's Proposed Interim Registration Review Decision for glyphosate and opened a 60-day public comment period on the proposed decision. EPA is hereby extending the comment period, which was set to end on July 5, 2019, to September 3, 2019.

To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES in the Federal Register document of May 6, 2019. If you have questions, consult the person listed under FOR FURTHER INFORMATION CONTACT .

As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

OMB Control No.: 3060-0192.

Title: Section 87.103, Posting Station License.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit, not-for-profit institutions, and state, local and tribal government.

Number of Respondents and Responses: 33,622 respondents, 33,622 responses.

Estimated Time per Response: .25 hours.

Frequency of Response: Recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 303.

Total Annual Burden: 8,406 hours.

Annual Cost Burden: No cost.

Privacy Act Impact Assessment: No impacts.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: Section 87.103 states the following: (a) Stations at fixed locations. The license or a photocopy must be posted or retained in the station's permanent records. (b) Aircraft radio stations. The license must be either posted in the aircraft or kept with the aircraft registration certificate. If a single authorization covers a fleet of aircraft, a copy of the license must be either posted in each aircraft or kept with each aircraft registration certificate. (c) Aeronautical mobile stations. The license must be retained as a permanent part of the station records. The recordkeeping requirement contained in Section 87.103 is necessary to demonstrate that all transmitters in the Aviation Service are properly licensed in accordance with the requirements of Section 301 of the Communications Act of 1934, as amended, 47 U.S.C. 301, No. 2020 of the International Radio Regulation, and Article 30 of the Convention on International Civil Aviation.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for June 19, 2019), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 26, 2019. Write “UnitedHealth Group and DaVita; File No. 181 0057” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online through the https://www.regulations.gov website.

If you prefer to file your comment on paper, write “UnitedHealth Group and DaVita; File No. 181 0057” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

Visit the FTC website at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before July 26, 2019. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from UnitedHealth Group Incorporated (“UnitedHealth Group”), Collaborative Care Holdings, LLC, DaVita Inc. (“DaVita”) and DaVita Medical Holdings, LLC (collectively, “Respondents”) to remedy the anticompetitive effects that otherwise would result from UnitedHealth Group's acquisition of DaVita Medical Group (“DMG”) (the “Proposed Acquisition”) in Clark and Nye Counties, Nevada (the “Las Vegas Area”). The proposed Consent Agreement, among other things, requires UnitedHealth Group to divest DMG assets related to the Healthcare Partners of Nevada (“HCPNV”) business to IHC Health Services, Inc. (“Intermountain Healthcare”) or another buyer approved by the Commission.

On December 5, 2017, UnitedHealth Group entered into an equity purchase agreement to acquire DaVita's DMG division. The Proposed Acquisition would combine the two largest managed care provider organizations (“MCPOs”) in the Las Vegas Area. The Proposed Acquisition would also combine DMG's MCPO with the largest Medicare Advantage insurer in the Las Vegas Area. On June 17, 2019, by a vote of 4-0-1, the Commission issued an administrative complaint alleging that the Proposed Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by (i) removing an actual, direct, and substantial competitor from the Las Vegas Area for MCPO services sold to Medicare Advantage health plans (“MA plans”) and (ii) lessening competition in the market for MA plans sold to individuals. The proposed Consent Agreement would remedy the alleged violations by requiring a complete divestiture of DMG's HCPNV assets relating to the HealthCare Partners Nevada business (“HCPNV Assets”) and granting certain related licenses. This divestiture will replace the competition that otherwise would be lost in the Las Vegas Area because of the Proposed Acquisition.

The proposed Consent Agreement has been placed on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the comments received and decide whether it should withdraw, modify, or make the Consent Agreement final.

UnitedHealth Group is a for-profit healthcare company headquartered in Minnetonka, Minnesota. UnitedHealth Group is comprised of two business entities: (1) UnitedHealthcare (“United”), which operates as United's health insurance branch; and (2) Optum, which operates as its health services unit. Within Optum is the OptumCare business segment, which includes employed medical groups, independent physicians associations (“IPAs”) or affiliated physician networks, ambulatory surgical centers, and urgent care centers. In 2018, United had revenues of $226.2 billion.

DaVita is the parent company to DMG and DaVita Kidney Care, its dialysis division. Headquartered in Denver, Colorado, DaVita had revenues of $11.4 billion in 2018. DMG operates medical groups and affiliated physician networks across six states: California, Colorado, Florida, Nevada, New Mexico, and Washington.

Individuals age 65 or over are eligible for Medicare, through which the federal government provides health insurance benefits to seniors. The provision of health insurance to Medicare-eligible beneficiaries is administered through two programs: (1) Government-provided Medicare (“Original Medicare”), and (2) privately-provided MA plans funded by the federal government. Under Original Medicare, a beneficiary receives inpatient acute care coverage under Medicare Part A and coverage for physician and outpatient services under Medicare Part B, and the federal government reimburses healthcare providers according to a fee schedule determined by the Centers for Medicare and Medicaid Services (“CMS”). Original Medicare enrollees may obtain care from any healthcare provider that accepts Original Medicare rates.

Rather than enroll in Original Medicare, a senior may choose to enroll in an MA plan sold by a private insurer. Under the Medicare Advantage (“MA”) program, the federal government pays private insurers to provide health insurance to Medicare-eligible seniors. Participating insurers, known as Medicare Advantage Organizations (“MAOs”), enter into contracts with CMS, pursuant to which they are permitted to offer MA plans to seniors. Many MA plans also offer vision, dental, hearing, or fitness benefits that are unavailable through Original Medicare.

The amount the federal government pays an MAO for each enrollee is determined by an annual bid process overseen by CMS. To be successful, MAOs need to deliver care at a cost that is below the payments they receive from CMS (plus any additional premiums they charge to enrollees). Accordingly, MAOs control costs by proactively managing the health of their enrollees to reduce the amount of healthcare services required by their enrollees.

Like commercial health insurance plans sold to the under-65 population, MA plans feature negotiations between MAOs and providers, provider networks, and plan designs that incentivize members to seek care from in-network providers. In order to align providers' financial incentives with their own, MAOs have implemented a number of different reimbursement models in their contracts with providers, and these models vary in the way “risk” is distributed between insurers and providers. In healthcare, “risk” refers to financial liability for unexpected medical expenditures. While some proportion of healthcare spending is predictable ( e.g., preventive care), a large proportion of healthcare spending goes to high-cost, low-probability events that are unexpected ( e.g., an emergency hospital admission or non-elective surgery). In some cases, those provider relationships are centered on risk-based contracts, which pay providers according to various measures of care quality, outcomes, or the ability to control healthcare costs rather than the volume of services they provide. When these cost control measures are successful, MAOs may funnel the savings back into their MA plans in the form of reduced out-of-pocket costs or additional benefits for members.

The Proposed Acquisition poses substantial antitrust concerns in two relevant product markets. First, the horizontal consolidation of the Optum and DMG MCPOs raises concerns in the market for the sale of MCPO services to MAOs and their members. Second, the vertical integration of DMG's MCPO and United's MAO business raises competition concerns in the market for MA plans sold to individuals.

One relevant service market in which to analyze the effects of the Proposed Acquisition is the sale of MCPO services to MAOs. An MAO's provider network—and its primary care physicians in particular—is critical to the success of the MAO. The most successful MAOs utilize networks of providers willing to work closely together to coordinate patient care and control healthcare costs. MCPOs are collaborative organizations of such healthcare providers. To varying degrees, MCPOs orchestrate networks of owned, employed, and affiliated providers—including hospitals, outpatient clinics, physician groups, and individual physicians—for the purpose of managing the care of an MA plan's patient population. MCPOs often employ a variety of clinical and non-clinical support personnel ( e.g., social workers, nurses, care coordinators, and utilization managers) and have developed information technology systems dedicated to managing care utilization and monitoring patient care.

MCPOs can materially affect the attractiveness of an MA plan to seniors. MA members seek MA plans that offer high quality networks at a competitive price. Without an MCPO's cost control and utilization management functions, an MAO faces a significant chance of increased costs, which can in turn increase MA plan prices and decrease the value of the MA plan's benefits. MCPOs also engage the MAO regularly to address performance issues and improve MA Plan quality scores.

The second relevant product market implicated by this transaction is the sale of MA plans to individuals. MA plans are meaningfully differentiated from other types of health insurance products, including Original Medicare plans, eligibility-restricted Medicare options ( e.g., special needs plans or “SNPs”), employer-group MA plans, and commercial health plans.

Once seniors “age into” Medicare, they may choose between coverage through Original Medicare or MA plans. As noted in United States v. Aetna Inc., 240 F. Supp. 3d 1 (D.D.C. 2017), seniors who choose to enroll in an MA plan overwhelmingly tend to remain in MA plans as opposed to transitioning to Original Medicare. MA plans are differentiated from Original Medicare in several important respects, including MA plans' limited networks, caps on out-of-pocket spending, coordination of care by providers, and members' access to supplemental benefits like prescription drug coverage. See Aetna, 240 F. Supp. 3d at 26-28, 30, 41. Therefore, the market for individual MA plans excludes Original Medicare. See Aetna, 240 F. Supp. 3d at 41.

The market for MA plans also excludes eligibility-restricted Medicare options such as SNPs and employer-group MA plans. SNPs are MA plans specifically designed to provide targeted care and limit enrollment to special needs individuals through specialized benefits and networks designed to treat specific conditions or needs. 1 Unless an individual MA member has or develops a qualifying need, that member cannot enroll in a SNP. Employer-group MA plans are customized for Medicare-eligible retirees of a particular employer. An MA enrollee cannot enroll in an employer-group MA plan unless they are a former employee of a participating employer.

Finally, the market for MA plans also excludes commercial health plans. MA plans often feature zero or very low premiums and are thus much less expensive for individuals compared to commercial health insurance products, which frequently charge much higher premiums. Seniors who purchase MA plans therefore are not likely to purchase a commercial health plan in the event of a price increase on all MA plans.

The relevant geographic market in which to analyze the effects of the Proposed Acquisition is no broader than the Las Vegas Area. Healthcare markets are local in nature. Evidence gathered from market participants shows that patients—and particularly seniors—strongly prefer to receive care as close to home as possible. Accordingly, MAOs that wish to market MA plans to seniors in the Las Vegas Area must offer MCPOs within the Las Vegas Area in their provider networks ( i.e., they cannot substitute MCPOs located outside the Las Vegas Area). Moreover, as a general matter, seniors may only subscribe to MA plans approved for sale in their county of residence. Therefore, a Medicare-eligible senior typically cannot substitute an MA plan approved for another county for an MA plan offered in their county of residence.

The Proposed Acquisition would likely result in substantial competitive harm to consumers in the two relevant markets. First, the Proposed Acquisition would combine the two leading MCPOs in the Las Vegas Area. Together, the Optum and DMG MCPOs cover more than 80% of MA members in the Las Vegas Area. Accordingly, the Proposed Acquisition would lead to a presumptively anticompetitive increase in market concentration in the MCPO market. This presumption of anticompetitive harm is supported by evidence of the close competition between Optum and DMG that would be eliminated by the Proposed Acquisition. Seniors in the Las Vegas Area benefit from this head-to-head competition in the form of lower health care costs and higher quality of care. If combined, DMG and Optum would gain additional leverage and be able to demand higher reimbursement rates from MAOs, and would have reduced incentives to maintain and improve their quality of care. Ultimately, these effects would be felt by local seniors in the form of higher premiums, co-pays, and out-of-pocket costs, as well as reduced access to high quality care.

The Proposed Acquisition would also likely harm competition in the market for MA plans sold to individuals in the Las Vegas Area by combining DMG's strong position in the MCPO market with United's strong position in the MAO market. The merged firm would have the incentive and ability to negotiate higher reimbursement rates for MCPO services from United's MAO rivals, making those rivals less competitive. This would worsen seniors' options, reduce competition, and ultimately increase prices or reduce quality ( e.g., supplemental benefits) in the market for MA plans sold to individuals in the Las Vegas Area.

The proposed Consent Agreement remedies the competitive concerns raised by the Proposed Acquisition by requiring UnitedHealth Group to divest the HCPNV Assets and grant related licenses to Intermountain Healthcare or another buyer approved by the Commission. The HCPNV Assets include all assets and rights related to the HCPNV business, including ownership interest in the relevant operating companies, rights under the medical group agreements, real property, governmental approvals, and business information. The proposed Consent Agreement requires the Respondents to provide transition services and allow the use of the HealthCare Partners brand for a period of time to facilitate the transfer of the business. In addition, the proposed Consent Agreement limits UnitedHealth Group and DaVita's use of, and access to, confidential business information pertaining to the divestiture assets.

With the HCPNV Assets and related licenses, Intermountain Healthcare can preserve the competition that currently exists in the two relevant markets. Intermountain Healthcare is a successful, not-for-profit healthcare system consisting of hospitals, clinics, medical groups, and a health plan, SelectHealth. Headquartered in Salt Lake City, Utah, Intermountain Healthcare serves MA patients across the entire continuum of care in Utah and Idaho. Intermountain Healthcare has the experience to ensure the continued use of the HCPNV business such that they remain an effective competitor to United in the Las Vegas Area. Moreover, Intermountain Healthcare is familiar with the Las Vegas Area through SelectHealth, which began offering an MA plan in Clark County this year. Intermountain Healthcare also has a minority ownership interest in P3 Health Group Holdings LLC, which owns and operates P3 Health Partners, a recent MCPO entrant to the Las Vegas Area. However, contingent on consummation of the proposed divestiture, Intermountain Healthcare has entered into a contract to divest this ownership interest in P3 Health Group Holdings, LLC, and forfeit its associated board seats. SelectHealth's current negligible share of the MA market in the Las Vegas Area and our analysis of Intermountain's and competitors' business incentives following the proposed divestiture indicate that Intermountain's ownership of SelectHealth does not raise concern for overall competition.

United must complete the divestiture within 40 days of closing the Proposed Acquisition. The proposed Consent Agreement provides for the appointment of a monitor to ensure UnitedHealth Group's and DaVita's compliance with the obligations set forth in the Orders. The proposed Consent Agreement requires Respondents to provide transition assistance to facilitate the transfer of the business to the buyer. The proposed Consent Agreement also contains appropriate compliance reporting requirements. If Respondents do not fully comply with the obligation to divest the HCPNV Assets, the Commission may appoint a Divestiture Trustee to divest the HCPNV Assets.

The proposed Consent Agreement contains a prior notice provision for subsequent acquisitions by Respondent UnitedHealth Group of any ownership interest in any healthcare provider in the Las Vegas Area. Under the proposed Consent Agreement, for the next ten years, Respondent UnitedHealth Group will be required to give the Commission 30 days' advanced notice of any such acquisition that is not subject to the Hart-Scott-Rodino Act, and provide a copy to the Attorney General of the State of Nevada. If 30 days expire without Commission action, Respondent UnitedHealth Group may consummate the proposed acquisition. Otherwise, Respondent UnitedHealth Group must produce to the Commission information and documents relating to the proposed acquisition in response to a written request, and not consummate the transaction until 20 days after substantially complying with the Commission's request.

The proposed Decision and Order will have a term of ten years.

The sole purpose of this analysis is to facilitate public comment on the proposed Consent Agreement. This analysis does not constitute an official interpretation of the proposed Consent Agreement or modify its terms in any way.

UnitedHealth Group, Inc. (“United”) proposes to acquire DaVita Medical Group (“DMG”). United's insurance business, operated by United's subsidiary UnitedHealthcare, offers commercial and Medicare Advantage (“MA”) health insurance plans to employer groups and individual consumers across the country. United and DMG both offer managed care provider organization (“MCPO”) services to health insurers. The merger is therefore both horizontal in nature—because it combines two competing MCPO service providers—and vertical, as it combines MCPO and insurance assets.

Staff spent more than a year and a half investigating the competitive effects of this acquisition, which involves assets in several states, including Colorado, Florida, New Mexico, Nevada, and Washington. Based on the findings from that investigation, the Commission has accepted a proposed consent agreement requiring United to divest DMG's healthcare provider organization (its MCPO) in the Las Vegas, Nevada, area to Intermountain Healthcare, a non-profit healthcare provider system without a presence in the market. We join Commissioners Slaughter and Chopra in supporting this remedy and in thanking staff for their exceptional effort and diligence through this long investigation.

Our colleagues write separately, stating they would have asked a federal judge to block United's acquisition of DMG based on their belief that the vertical integration of United's health insurance business and DMG's MCPOs and physicians in Colorado would harm consumers. In our view, the evidence in support of likely harm in Colorado was not compelling, and therefore a federal judge was unlikely to grant that relief.

As Commissioners Slaughter and Chopra point out, the acquisition in Colorado is purely vertical. In other words, in that state the transaction combines firms that operate at different levels of the supply chain and do not compete with one another. Specifically, DMG's MCPO services and physicians serve as “inputs” to the MA insurance plans that United and other health insurers sell to employers and individuals. The putative theory of harm in Colorado involved raising rivals' costs (“RRC”). It posited that, after acquiring DMG, United would find it profitable to raise DMG's prices to rival MA insurance plans, because doing so would reduce these plans' benefits and induce some customers to switch to United's MA products. The more business United recaptures in the market for MA plans, the greater its incentive to raise DMG's prices to rivals.

We do not rule out the possibility that vertical mergers can harm competition under a RRC theory. We both voted to issue the complaint, which alleges a similar vertical theory of harm in Nevada. And given both substantially stronger facts and the significant horizontal overlap in that state, that was the right call.

But vertical mergers often generate procompetitive benefits that must also factor into the antitrust analysis. 1 A major source of these benefits is the elimination of double-marginalization, which places downward pressure on prices in the output market. We conclude that the evidence in Colorado, quantitative and qualitative, reflected both dynamics, with mixed results. In our view, taken together, the evidence would not have convinced a judge that the proposed acquisition was likely, on balance, to harm consumers in Colorado.

As our colleagues note, a lawsuit based upon this evidence posed significant litigation risk. Among other things, the law on vertical mergers is relatively underdeveloped, and an adverse decision can impact enforcement in later cases that present clearer harm. Of course, all litigation presents risks, and sometimes the risks are worth taking. But, faced with a body of evidence of harm that was ambiguous in the first place, we cannot agree with our colleagues that this was a case on which to roll the dice.

UnitedHealth Group, Inc. (“United”) proposes to acquire DaVita Medical Group (“DMG”), which provides healthcare services in Nevada and Colorado, among other states. Today, the Commission voted to accept a proposed consent agreement that requires a divestiture of the DMG business serving Clark and Nye counties in Nevada to maintain competition. We agree with the proposed remedy for Nevada, but we disagree with the Commission's decision to not pursue an enforcement action in Colorado.

We believe the evidence uncovered by Commission staff demonstrates that the vertical merger of United's health insurance and DMG's healthcare services businesses would likely result in actionable harm to competition in Colorado. We were prepared to challenge the transaction in court, given the likelihood of harm. We acknowledge that Commission action involving Colorado would have borne significant litigation risks, but we believe such risks were worth taking.

Fortunately, the Attorney General of Colorado has taken action in an effort to address some of the harmful effects of the merger in a separate action. We hope all state attorneys general actively enforce the antitrust laws to protect their residents from harmful mergers and anticompetitive practices.

We thank Commission staff for their tireless work on a complex and very resource-intensive matter. While we would have preferred a different outcome, staff put the Commission in a very strong position to make a well-informed decision and serve the public interest.

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. The term “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 publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Reinstatement of a previously approved information collection; Title of Information Collection: Marketplace Quality Standards; Use: The Patient Protection and Affordable Care Act establishes requirements to support the delivery of quality health care coverage for health insurance issuers offering Qualified Health Plans (QHPs) in Exchanges. Section 1311(c)(3) of the Patient Protection and Affordable Care Act directs the Secretary to develop a system to rate QHPs on the basis of quality and price and requires Exchanges to display this quality rating information on their respective websites. Section 1311(c)(4) of the Patient Protection and Affordable Care Act requires the Secretary to develop an enrollee satisfaction survey system to assess enrollee experience with each QHP (with more than 500 enrollees in the previous year) offered through an Exchange. Section 1311(h) requires QHPs to contract with certain hospitals that meet specific patient safety and health care quality standards.

This collection of information is necessary to provide adequate and timely health care quality information for consumers, regulators, and Exchanges as well as to collect information to appropriately monitor and provide a process for a survey vendor to appeal HHS' decision to not approve a QHP Enrollee Survey vendor application. Form Number: CMS-10520 (OMB control number: 0938-1249); Frequency: Annually; Affected Public: Public sector (Individuals and Households), Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 264. Total Annual Responses: 264; Total Annual Hours: 348,764. For policy questions regarding this collection contact Nidhi Singh Shah at 301-492-5110. Type of Information Collection Request: Revision of a currently approved collection.

2. Title of Information Collection: State Agency Sheets for Verifying Exclusions from the Inpatient Prospective Payment System and Supporting Regulations—Rehabilitation Unit/Rehabilitation Hospital Criteria Worksheets; Use: The purpose of this information collection is to renew forms CMS-437A and 437B. Inpatient Rehabilitation Facility (IRF) hospitals and units must initially attest that they meet the Inpatient Prospective Payment System (IPPS) exclusion criteria set forth at 42 CFR 412.20 to 412.29 prior to being placed into IPPS exempt status. Form CMS-437A must be completed by IRF units and form CMS-437B must be completed by IRF hospitals.

For first time verification requests for exclusion from the IPPS, an IRF unit or hospital must notify the Regional Office (RO) servicing the State in which it is located that it believes it meets the criteria for exclusion from the IPPS. Currently, all new IRF units or hospitals must provide written certification that the inpatient population it intends to serve will meet the requirements of the IPPS exclusion criteria for IRFs. The completed CMS-437A and 437B forms are submitted to the State Agency (SA) no later than 5 months before the date the IRF unit or hospital would become subject to Inpatient Rehabilitation Facility Prospective Payment System (IRF-PPS). For IRF units and hospitals already excluded from the IPPS, annual onsite re-verification surveys by the SA are no longer required. IRF units and hospitals must now re-attest to meeting the exclusion criteria every 3 years thereafter.

IRF units and hospitals that have already been excluded need not reapply for exclusion. These facilities will automatically be reevaluated yearly to determine whether they continue to meet the exclusion criteria. For the tri-annual re-verification, IRF units and hospitals will be provided with a copy of the appropriate CMS-437 worksheet at least 5-months prior to the beginning of its cost reporting period, so that the IRF unit or hospital official may complete and sign an attestation statement and complete and return the appropriate form CMS-437A or CMS-437B at least 5-months prior to the beginning of the cost reporting period. However, Fiscal Intermediaries (FIs) will continue to verify, on an annual basis, compliance with the 60 percent rule (42 CFR 412.29(b)(2)) for IRF units and hospitals through a sample of medical records and the SA will verify the medical director requirement.

The SA will notify the RO at least 60 days prior to the end of the IRF unit's or hospital's cost reporting period of the status of compliance or non-compliance with the payment requirements. The information collected on the 437A and 437B forms, along with other information submitted by the IRF is necessary for determining the IRF's IPPS exclusion status. Form Number: CMS-437A and CMS-437B (OMB control number: 0938-0986); Frequency: tri-annually; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 1,126; Total Annual Responses: 1,126; Total Annual Hours: 1,126. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.)

Contents

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

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. The term “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 requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Use Review (DUR) Program; Use: States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient's name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist's comments relevant to the individual's drug therapy.

The States must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact.

Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States' DUR programs. The information submitted by States is reviewed and results are compiled by CMS in a format intended to provide information, comparisons, and trends related to States' experiences with DUR. States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 663; Total Annual Hours: 41,004. (For policy questions regarding this collection contact Mike Forman at 410-786-2666.)

2. Type of Information Collection Request: Reinstatement with change of a currently approved collection; Title of Information Collection: Data Use Agreement (DUA) Form; Use: The Privacy Act of 1974 allows for discretionary releases of data maintained in Privacy Act protected systems of records under § 552a(b) (Conditions of Disclosure). The mandate to account for disclosures of data under the Privacy Act is found at § 552a(c) (Accounting of Certain Disclosures). This section states that certain information must be maintained regarding disclosures made by each agency. This information is: Date, Nature, Purpose, and Name/Address of Recipient. Section 552a(e) sets the overall Agency Requirements that each agency must meet in order to maintain records under the Privacy Act.

The Data Use Agreement (DUA) form is needed as part of the review of each CMS data request to ensure compliance with the requirements of the Privacy Act for disclosures that contain PII. The DUA form also provides data requestors and custodians with a formal means to agree to the data protection and destruction statutory and regulatory requirements of CMS' PII data.

When entities, such as academic, federal or state agency researchers or CMS contractors request CMS PII/PHI data, they enter into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the recipient of CMS data must properly protect the data according to all applicable data security standards and also provide for its appropriate destruction at the completion of the project/study or the expiration date of the DUA. The DUA form enables the data recipient and CMS to document the request and approval for release of CMS data. Form Number: CMS-R-235 (OMB control number: 0938-0734); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 9,200; Total Annual Responses: 9,200; Total Annual Hours: 2,900. (For policy questions regarding this collection contact Kari A. Gaare at 410-786-8612.)

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Collection to Support Eligibility Determinations and Enrollment for Employers in the Small Business Health Options Program; Use: Section 1311(b)(1)(B) of the Affordable Care Act directs that the SHOP assist qualified small employers in facilitating the enrollment of their employees in QHPs offered in the small group market. Section 1311(c)(1)(F) of the Affordable Care Act directs HHS to establish criteria for certification of health plans as QHPs and plans to utilize a uniform enrollment form for qualified employers. Further, section 1311(c)(5)(B) directs HHS to develop a website that assists employers in determining if they are eligible to participate in SHOP. Form Number: CMS-10439 (OMB control number: 0938-1193); Frequency: Annually; Affected Public: Private Sector, Business or other for-profits, Not-for-profits institutions; Number of Respondents: 6,000; Total Annual Responses: 6,000; Total Annual Hours: 960. (For policy questions regarding this collection contact Michele Oshman at 410-786-4396.)

4. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Provider Network Coverage Data Collection; Use: The Affordable Care Act (ACA) established competitive private health insurance markets called Marketplaces, or Exchanges, which gave millions of Americans and small businesses access to affordable, quality insurance options that meet certain requirements. These requirements include ensuring sufficient choice of providers and providing information to enrollees and prospective enrollees on the availability of in-network and out-of-network providers. This information collection notice is for two of the standards from the HHS Notice of Benefit and Payment Parameters for 2017 (CMS-9937-F) final rule: One applying in the FFE and one applying to all QHPs. Specifically, under 45 CFR 156.230(d) and 156.230(e), we require notification requirements for enrollees in cases where a provider leaves the network and for cases where an enrollee might be seen by an out of network ancillary provider in in-network setting. These standards will help inform consumers about his or her health plan coverage to better make cost effective choices. The Centers for Medicare and Medicaid Services (CMS) is updating an information collection request (ICR) in connection with these standards. The burden estimates for this ICR included in this package reflects the additional time and effort for QHP issuers to provide these notifications to enrollees. Form Number: CMS-10594 (OMB control number: 0938-1302); Frequency: Yearly; Affected Public: Private Sector (business or other for-profits, not-for-profit institutions); Number of Respondents: 470; Total Annual Responses: 356,260; Total Annual Hours: 194,250. (For policy questions regarding this collection contact Arunima Shukla at 410-786-5017.)\

5. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Medicare Self-Referral Disclosure Protocol; Use: Section 6409 of the ACA requires the Secretary to establish a voluntary self-disclosure process that allows providers of services and suppliers to self-disclose actual or potential violations of section 1877 of the Act. In addition, section 6409(b) of the ACA gives the Secretary authority to reduce the amounts due and owing for the violations. To determine the nature and extent of the noncompliance and the appropriate amount by which an overpayment may be reduced, the Secretary must collect relevant information regarding the arrangements and financial relationships at issue from disclosing parties. The Secretary may also collect supporting documentation, such as contracts, leases, communications, invoices, or other documents bearing on the actual or potential violation(s). Most of the information and documentation required for submission to CMS in accordance with the SRDP is information that health care providers of services and suppliers keep as part of customary and usual business practices. Form Number: CMS-10328 (OMB control number: 0938-1106); Frequency: Yearly; Affected Public: Private Sector (business or other for-profits, not-for-profit institutions); Number of Respondents: 470; Total Annual Responses: 356,260; Total Annual Hours: 194,250. (For policy questions regarding this collection contact Matthew Edgar at 410-786-0698.)

6. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Medicare Participation Agreement for Physicians and Suppliers; Use: Section 1842(h) of the Social Security Act permits physicians and suppliers to voluntarily participate in Medicare Part B by agreeing to take assignment on all claims for services to Medicare beneficiaries. The law also requires that the Secretary provide specific benefits to the physicians, suppliers and other persons who choose to participate. The CMS-460 is the agreement by which the physician or supplier elects to participate in Medicare. By signing the agreement to participate in Medicare, the physician, supplier, or their authorized official agrees to accept the Medicare-determined payment for Medicare covered services as payment in full and to charge the Medicare Part B beneficiary no more than the applicable deductible or coinsurance for the covered services. For purposes of this explanation, the term “supplier” means certain other persons or entities, other than physicians, that may bill Medicare for Part B services ( e.g., suppliers of diagnostic tests, suppliers of radiology services, durable medical suppliers (DME) suppliers, nurse practitioners, clinical social workers, physician assistants). Institutions that render Part B services in their outpatient department are not considered “suppliers” for purposes of this agreement. Form Number: CMS-460(OMB control number: 0938-0373); Frequency: Yearly; Affected Public: Private Sector (business or other for-profits); Number of Respondents: 29,000; Total Annual Responses: 29,000; Total Annual Hours: 7,250. (For policy questions regarding this collection contact Mark Baldwin at 410-786-8139.)

This draft guidance provides draft recommendations for: (1) Complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation and (2) collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices. High intensity ultrasound systems for prostate tissue ablation transmit high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue. Other prostate ablation devices achieve the same clinical effect of ablating targeted tissue volumes using different sources of energy.

The scope of this draft guidance is limited to the clinical investigations of prostate tissue ablation systems to support marketing authorization for a general indication for ablation of prostatic tissue. This draft guidance does not address the clinical investigations of devices that are intended to treat specific prostatic diseases ( e.g., prostate cancer or benign prostatic hyperplasia). Additionally, this document does not address recommendations for non-clinical testing of prostate tissue ablation systems.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Clinical Investigations for Prostate Tissue Ablation Devices.” 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.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Clinical Investigations for Prostate Tissue Ablation Devices” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16011 to identify the guidance you are requesting.

This draft guidance refers to previously approved collections of information. 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table:

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.

FDA's “ Guidance for Administrative Procedures for CLIA Categorization ”  1 describes procedures FDA uses to assign the complexity category to a device, which affects what type of CLIA certificate the laboratory obtains. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization ( e.g., name change, exempt from 510(k) review). The guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available.

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

Based on recent receipt data for requests for CLIA categorization separate from a product application, the number of respondents is approximately 80. On average, each respondent requests such categorizations five times per year.

The cost, not including personnel, is estimated at $5 per submission (5 × 400), totaling $2,000. This includes the cost of copying and mailing copies of package inserts and a cover letter. The burden hours are based on FDA familiarity with the types of documentation typically included in a sponsor's categorization requests, and costs for basic office supplies ( e.g., paper). Upon review of this information collection, we have adjusted the estimated cost per submission (previously $52). Because the submissions are typically only a few pages per package insert and copying or printing and postage for a few pages is not expected to be more than $5, we believe this is a more appropriate cost burden estimate.

Our estimated burden for the information collection reflects an overall decrease of 500 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. Also, upon review of this information collection, we believe the previous estimate may have included requests for categorization associated with a premarket submission, the burden estimate of which is included under the OMB approval for the applicable premarket submission. We have therefore revised the number of respondents/responses to include only those that are separate from a product application, consistent with the scope of this information collection.

The United States Department of Health and Human Services (HHS) has long recognized that a high functioning health care system that provides higher quality care requires accurate, valid, and reliable measurements of quality and efficiency. The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) added section 1890 of the Social Security Act (the Act), which requires the Secretary to contract with the consensus-based entity (CBE) to perform multiple duties designed to help improve performance measurement. Section 3014 of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148) expanded the duties of the CBE to help in the identification of gaps in available measures and to improve the selection of measures used in health care programs.

HHS awarded a competitive contract to the National Quality Forum (NQF) in January 2009 to fulfill the requirements of section 1890 of the Act. A second, multi-year contract was awarded to NQF after an open competition in 2012. A third, multi-year contract was awarded again to NQF after an open competition in 2017. Section 1890(b) of the Act requires the following:

Priority Setting Process: Formulation of a National Strategy and Priorities for Health Care Performance Measurement. The CBE must synthesize evidence and convene key stakeholders to make recommendations on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In doing so, the CBE is to give priority to measures that: (1) Address the health care provided to patients with prevalent, high-cost chronic diseases; (2) have the greatest potential for improving quality, efficiency, and patient-centered health care; and (3) may be implemented rapidly due to existing evidence, standards of care, or other reasons. Additionally, the CBE must take into account measures that: (1) May assist consumers and patients in making informed health care decisions; (2) address health disparities across groups and areas; and (3) address the continuum of care across multiple providers, practitioners and settings.

Endorsement of Measures: The CBE must provide for the endorsement of standardized health care performance measures. This process must consider whether measures are evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, responsive to variations in patient characteristics such as health status, language capabilities, race or ethnicity, and income level, and are consistent across types of health care providers, including hospitals and physicians.

Maintenance of CBE Endorsed Measures: The CBE is required to establish and implement a process to ensure that endorsed measures are updated (or retired if obsolete) as new evidence is developed.

Review and Endorsement of an Episode Grouper Under the Physician Feedback Program: The CBE must provide for the review and, as appropriate, the endorsement of the episode grouper developed by the Secretary on an expedited basis.

Convening Multi-Stakeholder Groups: The CBE must convene multi-stakeholder groups to provide input on: (1) The selection of certain categories of quality and efficiency measures, from among such measures that have been endorsed by the entity; (2) such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (3) national priorities for improvement in population health and in the delivery of health care services for consideration under the national strategy. The CBE provides input on measures for use in certain specific Medicare programs, for use in programs that report performance information to the public, and for use in health care programs that are not included under the Act. The multi-stakeholder groups provide input on quality and efficiency measures for various federal health care quality reporting and quality improvement programs including those that address certain Medicare services provided through hospices, hospital inpatient and outpatient facilities, physician offices, cancer hospitals, end stage renal disease (ESRD) facilities, inpatient rehabilitation facilities, long-term care hospitals, psychiatric hospitals, and home health care programs.

Transmission of Multi-Stakeholder Input: Not later than February 1 of each year, the CBE must transmit to the Secretary the input of multi-stakeholder groups.

Annual Report to Congress and the Secretary: Not later than March 1 of each year, the CBE is required to submit to Congress and the Secretary an annual report. The report must describe:

• The implementation of quality and efficiency measurement initiatives and the coordination of such initiatives with quality and efficiency initiatives implemented by other payers;

• Recommendations on an integrated national strategy and priorities for health care performance measurement;

• Performance of the CBE's duties required under its contract with the Secretary;

• Gaps in endorsed quality and efficiency measures, including measures that are within priority areas identified by the Secretary under the national strategy established under section 399HH of the Public Health Service Act (National Quality Strategy), and where quality and efficiency measures are unavailable or inadequate to identify or address such gaps;

• Areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy, and where targeted research may address such gaps; and

• The convening of multi-stakeholder groups to provide input on: (1) The selection of quality and efficiency measures from among such measures that have been endorsed by the CBE and such measures that have not been considered for endorsement by the CBE but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and the delivery of health care services for consideration under the National Quality Strategy.

Section 50206(c)(1) of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) amended section 1890(b)(5)(A) of the Act to require the report to include the following each year: (1) An itemization of financial information for the previous fiscal year, including annual revenues of the entity, annual expenses of the entity, and a breakdown of the amount awarded per contracted task order and the specific projects funded in each task order assigned to the entity; and (2) any updates or modifications to internal policies and procedures as they relate to duties of the CBE, including, specifically identifying any modifications to the disclosure of interests and conflicts of interests for committees, work groups, task forces, and advisory panels of the entity, and information on external stakeholder participation in the duties of the entity.

The statutory requirements for the CBE to annually report to the Congress and the Secretary of HHS also specify that the Secretary must review and publish the CBE's annual report in the Federal Register , together with any comments of the Secretary on the report, not later than 6 months after receiving it.

This Federal Register notice complies with the statutory requirement for Secretarial review and publication of the CBE's annual report. NQF submitted a report on its 2018 activities to the Secretary on March 1, 2019. Comments from the Secretary on the report are presented in section II of this notice, and the National Quality Forum 2018 Activities Report to Congress and the Secretary of the Department of Health and Human Services is provided, as submitted to HHS, in the addendum to this Federal Register notice in section III.

Once again, we thank the NQF and the many stakeholders who participate in NQF projects for helping to advance the science and utility of health care quality measurement. As part of its annual recurring work to maintain a strong portfolio of endorsed measures for use across varied providers, settings of care, and health conditions, NQF reports that in 2018 it updated its measure portfolio by reviewing and endorsing or re-endorsing 38 measures and removing 40 measures. 1 Endorsed measures address a wide range of health care topics to promote value-based transformation of our health care system, and other HHS priorities, including: Person- and family-centered care; care coordination; palliative and end-of-life care; cardiovascular care; behavioral health; pulmonary/critical care; perinatal care; cancer treatment; patient safety; and cost and resource use.

In addition to maintaining measures endorsement, NQF also worked to remove measures from the portfolio for a variety of reasons, such as, measures no longer meeting endorsement criteria; harmonization between similar measures; replacement of outdated measures with improved measures; and lack of continued need for measures where providers consistently perform at the highest level. 2 This continuous refinement of the measures portfolio through the measures maintenance process ensures that quality measures remain aligned with current field practices and health care goals. Measure set refinements also align with HHS initiatives, such as the Meaningful Measures Initiative at Centers for Medicare and Medicaid Services (CMS). CMS is working to identify the highest priorities for quality measurement and improvement and promote patient-centered, outcome based measures that are meaningful to patients and clinicians.

NQF also undertook and continued a number of targeted projects dealing with difficult quality measurement issues. In particular, NQF has worked to help HHS address the unique challenges faced by rural communities. Nearly one in five Americans reside in rural communities and statistically, residents of rural communities tend to have worse health status than those living in urban areas. 3 HHS recognizes the unique challenges facing rural America, and with the support of partners like NQF, we are taking action to improve access and quality for healthcare providers serving rural patients. One of the biggest challenges rural Americans face is access to affordable quality health care. 4 5 6 Our reforms in the area of rural health are part of our overall strategy to update our programs and improve access to high quality services.

In 2018, recognizing the lack of representation from rural stakeholders in the pre-rulemaking process, HHS tasked NQF to establish a Measures Application Partnership (MAP) Rural Health Workgroup. The membership of the Workgroup, comprised of 18 organizational members, seven subject matter experts, and 3 federal liaisons, reflects the diversity of rural providers and residents, and allows for input from those most affected and most knowledgeable about rural measurement challenges and potential solutions. 7 With this valuable input from our partners and stakeholders, HHS can continue to improve health care in rural America.

The Workgroup identified a core set of the best available, “rural-relevant” measures to address the needs of the rural population and released a report providing recommendations regarding alignment and coordination of measurement efforts across both public and private programs, care settings, specialties, and sectors (both public and private). 8 NQF presented the Workgroup's finding on Capitol Hill to share this valuable work with members of the Congress. 9 The Workgroup also provided guidance for the Measures Application Partnership to ensure that the Measures Under Consideration (MUC) for use in CMS programs address the needs and challenges of rural providers and residents. 10 HHS is committed to evaluating our measurement practices and looking at them through a rural lens to ensure rural providers greater flexibility and less regulatory burden.

Additionally, CMS and NQF have worked together to address the low case-volume challenge as it pertains to healthcare performance measurement of rural providers. Low case-volume presents a significant measurement challenge for many rural providers. 11 Rural areas often are sparsely populated, which can affect the number of patients eligible for inclusion in healthcare performance measures, particularly condition- or procedure-specific measures. Other challenges faced by rural residents, such as distance to care or lack of transportation, can also lead to low case-volume in measurement. To develop recommendations to address the low case-volume challenge for rural providers, NQF convened a five-member Technical Expert Panel (TEP) comprised of statistical experts and measure methodologists. 12 The TEP released a report providing recommendations to CMS on how to best address the low case-volume challenge by incorporating new statistical methods into measures specifications. 13

Going forward, CMS will continue to work with NQF to strengthen the diversity of representation of the MAP Rural Health Workgroup. In particular, CMS is taking into account the largely rural nature of Tribal and Indian Health Service (IHS) health programs, their unique, cultural, funding, and legal status, and their specific challenges in participating in initiatives, which rely heavily on the use of clinical quality measures. For future NQF calls for nomination for the MAP Rural Health Workgroup, CMS will encourage NQF to sit representatives of Tribal Nations, Tribal health programs, or Tribal organizations. CMS will also reach out to IHS for recommendations of individuals with expertise in clinical quality measures and knowledge in health outcomes and barriers to care experienced by rural-dwelling Native Americans and nominate them as Workgroup members, and IHS staff with said expertise and experience as Federal Liaisons for the Workgroup. In addition, CMS will ask NQF to reach out to Tribal Nations, Tribal Health programs, and Tribal organizations for input during the public comment periods for project deliverables.

Addressing the needs of rural health communities is just one of many areas in which NQF partners with HHS in enhancing and protecting the health and well-being of all Americans. Meaningful quality measurement is essential to healthcare delivery reform, as evidenced in many of the targeted projects that NQF is being asked to undertake. HHS greatly appreciates the ability to bring many and diverse stakeholders to the table to help develop the strongest possible approaches to quality measurement as a key component to health care delivery system reform. We appreciate the strong partnership with the NQF in this ongoing endeavor.

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. 3501 et seq. ).

In this Addendum, we are publishing the NQF Report on 2018 Activities to Congress and the Secretary of the Department of Health and Human Services, as submitted to HHS.