The purpose of the meeting is to review, discuss, recommend, and approve new Title II projects. The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by Tuesday, July 21, 2020, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the RAC may file written statements with the RAC staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Sheila Holifield, RAC Coordinator by email to sheila.holifield@usda.gov.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening

devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT . All reasonable accommodation requests are managed on a case-by-case basis.

Title: Annual Survey of Farmer Cooperatives.

OMB Number: 0570-0007.

Type of Request: Revision of a currently approved information collection.

Abstract: One of the objectives of RBCS is to promote the understanding, use and development of the cooperative form of business as a viable option for enhancing the income of agricultural producers and other rural residents. RBCS direct role is providing knowledge to improve the effectiveness and performance of farmer cooperative businesses through technical assistance, research, information, and education. The annual survey of farmer cooperatives collects basic statistics on cooperative business volume, net income, members, financial status, employees, and other selected information to support RBCS' objective and role. Cooperative statistics are published in an annual report and other formats for use by the U.S. Department of Agriculture, cooperative management and members, educators and researchers, other Federal agencies, cooperative trade associations, general agribusiness, cooperative development practitioners, students, teachers, consultants, and many others.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 76 minutes or less per response.

Respondents: Farmer, rancher, and fishery cooperatives.

Estimated Number of Respondents: 1,037.

Estimated Number of Responses per Respondent: 1.

Estimated Number of Responses: 1,037.

Estimated Total Annual Burden on Respondents: 792 Hours.

The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RBCS is submitting to OMB for approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) The accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) Ways to enhance the quality, utility and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments may be sent by the Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the lower “Search Regulations and Federal Actions” box, select “Rural Business-Cooperative Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select RBS-20-CO-OP-0024 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov , including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.

Copies of this information collection can be obtained from Pamela Bennett, Rural Development Innovation Center, Regulations Management Division, at (202) 720-9639. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The Agency encourages applications that will support recommendations made in the Rural Prosperity Task Force report to help improve life in rural America. www.usda.gov/ruralprosperity Applicants are encouraged to consider projects that provide measurable results in helping rural communities build robust and sustainable economies through strategic investments in infrastructure, partnerships and innovation. Key strategies include:

Federal Agency: Rural Business-Cooperative Service.

Funding Opportunity Title: Rural Cooperative Development Grants.

Announcement Type: Initial Notice.

Catalog of Federal Domestic Assistance Number: 10.771.

Date: Application Deadline. Electronic applications must be received by http://www.grants.gov no later than midnight Eastern Time, August 3, 2020, or it will not be considered for funding.

The Application Template provides specific, detailed instructions for each item of a complete application. The Agency emphasizes the importance of including every item and strongly encourages applicants to follow the instructions carefully, using the examples and illustrations in the Application Template. Prior to official submission of applications, applicants may request technical assistance or other application guidance from the Agency, as long as such requests are made prior to August 3, 2020. Agency contact information can be found in Section D of this document.

Hemp related projects: Please note that no assistance or funding can be provided to a hemp producer unless they have a valid license issued from an approved State, Tribal or Federal plan as defined by the Agriculture Improvement Act of 2018, Public Law 115-334. Verification of valid hemp licenses will occur at the time of award.

Persistent poverty counties: The Further Consolidated Appropriations Act, 2020, SEC. 740 designates funding for projects in Persistent Poverty counties. Persistent Poverty counties as defined in SEC. 740 is “any county that has had 20 percent or more of its population living in poverty over the past 30 years, as measured by the 1990 and 2000 decennial censuses, and 2007-2011 American Community Survey 5-year average, or any territory or possession of the United States”. Another provision in SEC. 740 expands the eligible population in Persistent Poverty counties to include any county seat of such a persistent poverty county that has a population that does not exceed the authorized population limit by more than 10 percent. This provision expands the current 50,000 population limit to 55,000 for only county seats located in Persistent Poverty counties. Therefore, applicants and/or beneficiaries of technical assistance services located in Persistent Poverty county seats with populations up to 55,000 (per the 2010 Census) are eligible.

COVID-19 Administrative Relief Exceptions: The Agency reviewed the Office of Budget and Management's (OMB) M-20-17 memorandum “Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations”, and OMB M-20-11, “Administrative Relief for Recipients and Applicants of Federal Financial Assistance directly impacted by the novel coronavirus (COVID-19)”, cited and referenced by M-20-17 and has made every attempt to reduce administrative burden within our authority. Any reduction in burden will be discussed within the requirement.

The Agency will not solicit or consider new scoring or eligibility information that is submitted after the application deadline. The Agency reserves the right to contact applicants to seek clarification on materials contained in the submitted application. See the Application Template for a full discussion of each item. For requirements of completed grant applications, refer to Section D of this document.

In accordance with the Paperwork Reduction Act, the paperwork burden associated with this Notice has been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0006.

The RCDG program is authorized under section 310B(e) of the Consolidated Farm and Rural Development Act (CONACT) (7 U.S.C. 1932 (e)) as amended by the Agriculture Improvement Act of 2018 (Pub. L. 115-334). You are required to comply with the regulations for this program published at 7 CFR part 4284, subparts A and F, which are incorporated by reference in this Notice. Therefore, you should become familiar with these regulations. The primary objective of the RCDG program is to improve the economic condition of rural areas through cooperative development. Grants are awarded on a competitive basis. The maximum award amount per grant is $200,000. Grants are available for non-profit corporations or higher education institutions only. Grant funds may be used to pay for up to 75 percent of the cost of establishing and operating centers for rural cooperative development. Grant funds may be used to pay for 95 percent of the cost of establishing and operating centers for rural cooperative development when the applicant is a 1994 Institution as defined by 7 U.S.C. 301. The 1994 Institutions are commonly known as Tribal Land Grant Institutions. Centers may have the expertise on staff, or they can contract out for the expertise to assist individuals or entities in the startup, expansion or operational improvement of rural businesses, especially cooperative or mutually-owned businesses.

The terms you need to understand are defined and published at 7 CFR 4284.3 and 7 CFR 4284.504. In addition, the terms “rural” and “rural area,” defined at section 343(a) (13) of the CONACT (7 U.S.C. 1991(a)), are incorporated by reference, and will be used for this program instead of those terms currently published at 7 CFR 4284.3. The term “you” referenced throughout this Notice should be understood to mean “you” the applicant. Finally, there has been some confusion on the Agency's meaning of the terms “conflict of interest” and “mutually-owned business” because they are not defined in the CONACT or in the regulations used for the program. Therefore, the terms are clarified and should be understood as follows.

Conflict of interest —A situation in which a person or entity has competing personal, professional, or financial interests that make it difficult for the person or business to act impartially. Regarding use of both grant and matching funds, Federal procurement standards prohibit transactions that involve a real or apparent conflict of interest for owners, employees, officers, agents, or their immediate family members having a financial or other interest in the outcome of the project; or that restrict open and free competition for unrestrained trade. Specifically, project funds may not be used for services or goods going to, or coming from, a person or entity with a real or apparent conflict of interest, including, but not limited to, owner(s) and their immediate family members. An example of conflict of interest occurs when the grantee's employees, board of directors, or the immediate family of either, have the appearance of a professional or personal financial interest in the recipients receiving the benefits or services of the grant.

Mutually-owned business —An organization owned and governed by members who either are its consumers, producers, employees, or suppliers.

Type of Award: Competitive Grant.

Fiscal Year Funds: FY 2020.

Total Funding: $5,800,000.

Maximum Award: $200,000.

Anticipated Award Date: September 30, 2020.

Applicants must meet all of the following eligibility requirements. Applications which fail to meet any of these requirements by the application deadline will be deemed ineligible and will not be evaluated further.

You must be a nonprofit corporation or an institution of higher education to apply for this program. Public bodies and individuals cannot apply for this program. See 7 CFR 4284.507. You must also meet the following requirements:

a. An applicant is ineligible if they have been debarred or suspended or otherwise excluded from or ineligible for participation in Federal assistance programs under Executive Order 12549, “Debarment and Suspension.” The Agency will check the System for Award Management (SAM) to determine if the applicant has been debarred or suspended. In addition, an applicant will be considered ineligible for a grant due to an outstanding judgment obtained by the U.S. in a Federal Court (other than U.S. Tax Court), is delinquent on the payment of Federal income taxes, or is delinquent on Federal debt. See 7 CFR 4284.6. The applicant must certify as part of the application that they do not have an outstanding judgment against them. The Agency will check the Do Not Pay System to verify this information.

b. Any corporation that has been convicted of a felony criminal violation under any Federal law within the past 24 months or that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance provided with funds appropriated by the Further Consolidated Appropriations Act, 2020 (Pub. L. 116-94), unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government. Note: You no longer must complete the Form AD 3030, “Representation Regarding Felony Corporations and Tax Delinquent Status for Corporate Applicants” as a part of your application. This information is now collected through your registration or annual recertification in SAM.gov via the Financial Assistance General Certifications and Representations.

c. Applications will be deemed ineligible if the application includes any funding restrictions identified under Section D.6. a and b. Inclusion of funding restrictions outlined in Section D.6. a. and b. preclude the Agency from making a federal award.

d. Applications will be deemed ineligible if the application is not complete in accordance with the requirements stated in Section C.3.

Your matching funds requirement is 25 percent of the total project cost (5 percent for 1994 Institutions). See 7 CFR 4284.508. When you calculate your matching funds requirement, please round up or down to whole dollars as appropriate. An example of how to calculate your matching funds is as follows:

a. Take the amount of grant funds you are requesting and divide it by .75. This will give you your total project cost.

b. Subtract the amount of grant funds you are requesting from your total project cost. This will give you your matching funds requirement.

c. A quick way to double check that you have the correct amount of matching funds is to take your total project cost and multiply it by .25.

You must verify that all matching funds are available during the grant period and provide this documentation with your application in accordance with requirements identified in Section D.2.e.8. If you are awarded a grant, additional verification documentation may be required to confirm the availability of matching funds.

Other rules for matching funds that you must follow are listed below.

• They must be spent on eligible expenses during the grant period.

• They must be from eligible sources.

• They must be spent in advance or as a pro-rata portion of grant funds being spent.

• They must be provided by either the applicant or a third party in the form of cash or an in-kind contribution.

• They cannot include board/advisory council member's time.

• They cannot include other Federal grants unless provided by authorizing legislation.

• They cannot include cash or in-kind contributions donated outside of the grant period.

• They cannot include over-valued, in-kind contributions.

• They cannot include any project costs that are ineligible under the RCDG program.

• They cannot include any project costs that are restricted or unallowable under 2 CFR part 200, subpart E, and the Federal Acquisition Regulation (for-profits) or successor regulation.

• They can include loan funds from a Federal source.

• They can include travel and incidentals for board/advisory council members if you have established written policies explaining how these costs are normally reimbursed, including rates. You must include an explanation of this policy in your application or the contributions will not be considered as eligible matching funds.

• You must be able to document and verify the number of hours worked and the value associated with any in-kind contribution being used to meet a matching funds requirement.

• In-kind contributions provided by individuals, businesses, or cooperatives which are being assisted by you cannot be provided for the direct benefit of their own projects as USDA Rural Development considers this to be a conflict of interest or the appearance of a conflict of interest.

Your application will not be considered for funding if it fails to meet an eligibility criterion by time of application deadline or does not provide sufficient information to determine eligibility and scoring. You must include all of the forms and proposal elements as discussed in the regulation and as clarified further in this Notice in one package. Incomplete applications will not be reviewed by the Agency. For more information on what is required for a complete application, see 7 CFR 4284.510.

Your application must propose the establishment or continuation of a cooperative development center concept. You must use project funds, including grant and matching funds, for eligible purposes only (see 7 CFR 4284.508). In addition, project funds may also be used for programs providing for the coordination of services and sharing of information among the centers (see 7 U.S.C 1932(e)(4)(C)(vi)).

All project activities must be for the benefit of a rural area.

Only one application can be submitted per applicant. If two applications are submitted (regardless of the applicant name) that include the same Executive Director and/or advisory boards or committees of an existing center, both applications will be determined ineligible for funding.

Your application must include no more than a one-year grant period, or it will not be considered for funding. The grant period should begin no earlier than October 1, 2020, and no later than January 1, 2021. Applications that request funds for a time period ending after January 1, 2021, will not be considered for funding. Projects must be completed within a one-year timeframe. Prior approval is needed from the Agency if you are awarded a grant and desire the grant period to begin earlier or later than previously discussed or approved.

The Agency may approve requests for a one-time extension up to 12 months at its discretion. However, you may not have more than one active RCDG during the same grant period. Further guidance on grant period extensions will be provided in the award document. The Agency understands that fiscal year 2019 recipients may have had loss of operations due to COVID-19 and will work with them to determine an acceptable grant period if they are awarded in fiscal year 2020 in accordance with OMB Memoranda M-20-17 and 2 CFR 200.308.

You must be performing satisfactorily on any outstanding RCDG award to be considered eligible for a new award. Satisfactory performance includes being up-to-date on all financial and performance reports as prescribed in the grant award, and current on tasks and timeframes for utilizing grant and matching funds as approved in the work plan and budget. If you have any unspent grant funds on RCDG awards prior to fiscal year 2019, your application will not be considered for funding. If your fiscal year 2019 award has unspent funds of 50 percent or more than what your approved work plan and budget projected at the time that your fiscal year 2020 application is being evaluated, your application will not be considered for funding. The Agency will verify the performance status of the applicant's FY 2019 awards and make a determination after the FY 2020 application period closes. The Agency understands that fiscal year 2019 recipients may have had a loss of operations due to COVID-19 and will consider providing flexibility in terms of fund utilization on FY 19 awards with acceptable justification of delays resulting from the COVID-19 pandemic in accordance with OMB Memorandum M-20-17 and 2 CFR 200.343.

Your application must demonstrate that you are providing services to new customers or new services to current customers. If your work plan and budget is duplicative of your existing award, your application will not be considered for funding. If your workplan and budget is duplicative of a previous or existing RCDG and/or Socially Disadvantaged Groups Grant (SDGG) award, your application will not be considered for funding. The Agency will make this determination. Please note that the Agency only allows one active award to ensure that there is no duplication of services. The Agency will work with FY 2019 recipients who request an extension of their FY 2019 award due to COVID-19 loss of operations to determine an acceptable grant period if they are awarded in fiscal year 2020 in accordance with OMB Memorandum M-20-17 and 2 CFR 200.343. Thus, requesting an extension on a FY 2019 award is not cause for deeming a FY 2020 application ineligible.

Your negotiated indirect cost rate approval does not need to be included in your application, but you will be required to provide it if a grant is awarded. Approval for indirect costs that are requested in an application without an approved indirect cost rate agreement is at the discretion of the Agency.

For further information, you should contact your State Office at http://www.rd.usda.gov/contact-us/state-offices. Program materials may also be obtained at http://www.rd.usda.gov/programs-services/rural-cooperative-development-grant-program.

You may submit your application electronically through Grants.gov . You are encouraged, but not required to utilize the application template found at http://www.rd.usda.gov/programs-services/rural-cooperative-development-grant-program.

An optional-use Agency application template is available online at http://www.rd.usda.gov/programs-services/rural-cooperative-development-grant-program.

To apply electronically, you must use the Grants.gov website at http://www.Grants.gov. You may not apply electronically in any way other than through Grants.gov .

You can locate the Grants.gov downloadable application package for this program by using a keyword, the program name, or the Catalog of Federal Domestic Assistance Number for this program.

When you enter the Grants.gov website, you will find information about applying electronically through the site, as well as the hours of operation.

To use Grants.gov , you must already have a DUNS number and you must also be registered and maintain registration in SAM. We strongly recommend that you do not wait until the application deadline date to begin the application process through Grants.gov .

You must submit all your application documents electronically through Grants.gov . Applications must include electronic signatures. Original signatures may be required if funds are awarded.

After electronically applying through Grants.gov , you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.Supplemental Information

Your application must contain all the required forms and proposal elements described in 7 CFR 4284.510 and as otherwise clarified in this Notice. Specifically, your application must include: (1) The required forms as described in 7 CFR 4284.510(b) and (2) the required proposal elements as described in 7 CFR 4284.510(c). If your application is incomplete, it is ineligible to compete for funds. Applications lacking sufficient information to determine eligibility and scoring will be considered ineligible. Information submitted after the application deadline will not be accepted.

• Your DUNS number should be identified in the “Organizational DUNS” field on Standard Form (SF) 424, “Application for Federal Assistance.” You must also provide your SAM Commercial and Government Entity (CAGE) Code and expiration date under the applicant eligibility discussion in your proposal narrative. If you do not include the CAGE code and expiration date and the DUNS number in your application, it will not be considered for funding. In accordance with OMB Memoranda M-20-17, the Agency can accept an application without an active SAM registration. However, the registration must be completed before an award is made. Current registrants in SAM with active registrations expiring before May 16, 2020 will be afforded a one-time extension of 60 days.

• You no longer must complete the Form SF 424B, “Assurances—Non-Construction Programs” as a part of your application. This information is now collected through your registration or annual recertification in SAM.gov through the Financial Assistance General Certifications and Representation.

• You can voluntarily fill out and submit the “Survey on Ensuring Equal Opportunity for Applicants,” as part of your application if you are a nonprofit organization.

d. Clarifications on Proposal Elements

1. You must include the title of the project as well as any other relevant identifying information on the Title Page.

2. You must include a Table of Contents with page numbers for each component of the application to facilitate review.

3. Your Executive Summary must include the items in 7 CFR 4284.510(c)(3) and discuss the percentage of work that will be performed among organizational staff, consultants, or other contractors. It should not exceed two pages.

4. Your Eligibility Discussion must not exceed two pages and cover how you meet the applicant eligibility requirements, matching funds, and other eligibility requirements.

5. Your Proposal Narrative must not exceed 40 pages using at least 11-point font and should describe the essential aspects of the project.

i. You are required to only have one title page for the proposal.

ii. If you list the evaluation criteria on the Table of Contents and then specifically and individually address each criterion in narrative form, it is not necessary for you to include an Information Sheet. Otherwise, the Information Sheet is required under 7 CFR 4284.510 (c)(5)(ii).

iii. You must include the following under Goals of the Project:

A. A statement that substantiates that the Center will effectively serve rural areas in the United States;

B. A statement that the primary objective of the Center will be to improve the economic condition of rural areas through cooperative development;

C. A description of the contributions that the proposed activities are likely to make to the improvement of the economic conditions of the rural areas for which the Center will provide services. Expected economic impacts should be tied to tasks included in the work plan and budget; and

D. A statement that the Center, in carrying out its activities, will seek, where appropriate, the advice, participation, expertise, and assistance of representatives of business, industry, educational institutions, the Federal government, and State and local governments.

iv. The Agency has established annual performance evaluation measures to evaluate the RCDG program. You must provide estimates on the following performance evaluation measures:

• Number of groups assisted who are not legal entities.

• Number of businesses assisted that are not cooperatives.

• Number of cooperatives assisted.

• Number of businesses incorporated that are not cooperatives.

• Number of cooperatives incorporated.

• Total number of jobs created as a result of assistance.

• Total number of jobs saved as a result of assistance.

• Number of jobs created for the Center as a result of RCDG funding.

• Number of jobs saved for the Center as a result of RCDG funding.

It is permissible to have a zero in a performance element. When you calculate jobs created, estimates should be based upon actual jobs to be created by your organization because of the RCDG funding or actual jobs to be created by cooperative businesses or other businesses as a result of assistance from your organization. When you calculate jobs saved, estimates should be based only on actual jobs that would have been lost if your organization did not receive RCDG funding or actual jobs that would have been lost without assistance from your organization.

v. You can also suggest additional performance elements, for example, where job creation or jobs saved may not be a relevant indicator ( e.g., housing). These additional criteria should be specific, measurable performance elements that could be included in an award document.

vi. You must describe in the application how you will undertake each of the following and prefer that you described these undertakings within the noted proposal evaluation criteria to reduce duplication in your application. The specific proposal evaluation criterion where you should address each undertaking is noted below.

A. Take all practicable steps to develop continuing sources of financial support for the Center, particularly from sources in the private sector (should be presented under proposal evaluation criterion j., utilizing the specific requirements of Section E.1.j.);

B. Make arrangements for the Center's activities to be monitored and evaluated (should be addressed under proposal evaluation criterion number h. utilizing the specific requirements of Section E.1.h.); and

C. Provide an accounting for the money received by the grantee in accordance with 7 CFR part 4284, subpart F. This should be addressed under proposal evaluation criterion number a., utilizing the specific requirements of Section E.1.a.

vii. You should present the Work Plan and Budget proposal element under proposal evaluation criterion number h., utilizing the specific requirements of Section E.1.h. of this Notice to reduce duplication in your application.

viii. You should present the Delivery of Cooperative development assistance proposal element under proposal evaluation criterion number b., utilizing the specific requirements of Section E.1.b. of this Notice.

ix. You should present the Qualifications of Personnel proposal element under proposal evaluation criterion number i., utilizing the specific requirements of Section E.1.i. of this Notice.

x. You should present the Local Support and Future Support proposal elements under proposal evaluation criterion number j., utilizing the requirements of Section E.1.j. of this Notice.

xi. Your application will not be considered for funding if you do not address all of the proposal evaluation criteria. See Section E.1. of this Notice for a description of the proposal evaluation criteria.

xii. Only appendices A-C will be considered when evaluating your application. You must not include resumes of staff or consultants in the application.

6. You must certify that there are no current outstanding Federal judgments against your property and that you will not use grant funds to pay for any judgment obtained by the United States. To satisfy the Certification requirement, you should include this statement in your application: “[INSERT NAME OF APPLICANT] certifies that the United States has not obtained an unsatisfied judgment against its property, is not delinquent on the payment of Federal income taxes, or any Federal debt, and will not use grant funds to pay any judgments obtained by the United States.” A separate signature is not required.

7. You must certify that matching funds will be available at the same time grant funds are anticipated to be spent and that expenditures of matching funds are pro-rated or spent in advance of grant funding, such that for every dollar of the total project cost, not less than the required amount of matching funds will be expended. Please note that this Certification is a separate requirement from the Verification of Matching Funds requirement. To satisfy the Certification requirement, you should include this statement in your application: “[INSERT NAME OF APPLICANT] certifies that matching funds will be available at the same time grant funds are anticipated to be spent and that expenditures of matching funds shall be pro-rated or spent in advance of grant funding, such that for every dollar of the total project cost, at least 25 cents (5 cents for 1994 Institutions) of matching funds will be expended.” A separate signature is not required.

8. You must provide documentation in your application to verify all of your proposed matching funds. The documentation must be included in Appendix A of your application and will not count towards the 40-page limitation. Template letters are available for each type of matching funds contribution at: http://www.rd.usda.gov/programs-services/rural-cooperative-development-grant-program.

a. If matching funds are to be provided in cash, you must meet the following requirements:

• You: The application must include a statement verifying (1) the amount of the cash and (2) the source of the cash. You may also provide a bank statement dated 30 days or less from the application deadline date to verify your cash match.

• Third-party: The application must include a signed letter from the third party verifying (1) how much cash will be donated and (2) that it will be available corresponding to the proposed grant period or donated on a specific date within the grant period.

b. If matching funds are to be provided by an in-kind donation, you must meet the following requirements:

• You: The application must include a signed letter from you or your authorized representative verifying (1) the nature of the goods and/or services to be donated and how they will be used, (2) when the goods and/or services will be donated ( i.e., corresponding to the proposed grant period or to specific dates within the grant period), and (3) the value of the goods and/or services. Please note that most applicant contributions for the RCDG program are considered applicant cash match in accordance with this Notice. If you are unsure, please contact your State Office because identifying your matching funds improperly can affect your scoring.

• Third-Party: The application must include a signed letter from the third party verifying (1) the nature of the goods and/or services to be donated and how they will be used, (2) when the goods and/or services will be donated ( i.e., corresponding to the proposed grant period or to specific dates within the grant period), and (3) the value of the goods and/or services.

To ensure that you are identifying and verifying your matching funds appropriately, please note the following:

• If you are paying for goods and/or services as part of the matching funds requirement, the expenditure is considered a cash match, and you must verify it as such. Universities must verify the goods and services they are providing to the project as a cash match and the verification must be approved by the appropriate approval official ( i.e., sponsored programs office or equivalent).

• If you have already received cash from a third-party ( i.e., Foundation) before the start of your proposed grant period, you must verify this as your own cash match and not as a third-party cash match. If you are receiving cash from a third-party during the grant period, then you must be verifying the cash as a third-party cash match.

• Board resolutions for a cash match must be approved at the time of application.

• You can only consider goods or services for which no expenditure is made as an in-kind contribution.

• If a non-profit or another organization contributes the services of affiliated volunteers, they must follow the third-party, in-kind donation verification requirement for each individual volunteer.

• Expected program income may not be used to fulfill your matching funds requirement at the time you submit your application. However, if you have a contract to provide services in place at the time you submit your application, you can verify the amount of the contract as a cash match.

• The valuation processes used for in-kind contributions does not need to be included in your application, but you must be able to demonstrate how the valuation was derived if you are awarded a grant. The grant award may be withdrawn, or the amount of the grant reduced if you cannot demonstrate how the valuation was derived.

Successful applicants must comply with requirements identified in Section F, Federal Award Administration.

To be eligible (unless you are excepted under 2 CFR 25.110(b), (c) or (d)), you are required to:

(a) Provide a valid DUNS number in your application, which can be obtained at no cost via a toll-free request line at (866) 705-5711;

(b) Register in SAM before submitting your application. You may register in SAM at no cost at https://www.sam.gov/portal/public/SAM/. You must provide your SAM CAGE Code and expiration date. When registering in SAM, you must indicate you are applying for a Federal financial assistance project or program or are currently the recipient of funding under any Federal financial assistance project or program, and

(c) The SAM registration must remain active with current information at all times while RBCS is considering an application or while a Federal grant award or loan is active. To maintain the registration in the SAM database the applicant must review and update the information in the SAM database annually from date of initial registration or from the date of the last update. The applicant must ensure that the information in the database is current, accurate, and complete. Applicants must ensure they complete the Financial Assistance General Certifications and Representations in SAM

If you have not fully complied with all applicable DUNS and SAM requirements, the Agency may determine that the applicant is not qualified to receive a Federal award and the Agency may use that determination as a basis for making an award to another applicant. In accordance with OMB Memoranda M-20-17, the Agency can accept an application without an active SAM registration. However, the registration must be completed before an award is made. Current registrants in SAM with active registrations expiring before May 16, 2020 will be afforded a one-time extension of 60 days. Please refer to Section F.2. for additional submission requirements that apply to grantees selected for this program.

Explanation of Deadline: Completed applications must be submitted electronically by no later than midnight Eastern Time, August 17, 2020, through Grants.gov , to be eligible for grant funding. Please review the Grants.gov website at https://www.grants.gov/web/grants/register.html for instructions on the process of registering your organization as soon as possible to ensure that you can meet the electronic application deadline. Grants.gov will not accept applications submitted after the deadline.

Executive Order (E.O.) 12372, “Intergovernmental Review of Federal Programs,” applies to this program. This E.O. requires that Federal agencies provide opportunities for consultation on proposed assistance with State and local governments. Many States have established a Single Point of Contact (SPOC) to facilitate this consultation. For a list of States that maintain a SPOC, please see the White House website: https://www.whitehouse.gov/wp-content/uploads/2017/11/SPOC-Feb.-2018.pdf. If your State has a SPOC, you may submit a copy of the application directly for review. Any comments obtained through the SPOC must be provided to your State Office for consideration as part of your application. If your State has not established a SPOC, or if you do not want to submit a copy of the application, our State Offices will submit your application to the SPOC or other appropriate agency or agencies.

a. Project funds, including grant and matching funds, cannot be used for ineligible grant purposes (see 7 CFR 4284.10). Also, you shall not use project funds for the following:

• To purchase, rent, or install laboratory equipment or processing machinery;

• To pay for the operating costs of any entity receiving assistance from the Center;

• To pay costs of the project where a conflict of interest exists;

• To fund any activities prohibited by 2 CFR part 200; or

• To fund any activities considered unallowable by 2 CFR part 200, subpart E, “Cost Principles,” and the Federal Acquisition Regulation (for-profits) or successor regulations.

b. In addition, your application will not be considered for funding if it does any of the following:

• Focuses assistance on only one cooperative or mutually-owned business;

• Requests more than the maximum grant amount; or

• Proposes ineligible costs that equal more than 10 percent of total project costs. The ineligible costs will NOT be removed at this stage to proceed with application processing. For purposes of this determination, the grant amount requested plus the matching funds amount constitutes the total project costs.

We will consider your application for funding if it includes ineligible costs of 10 percent or less of total project costs, if the remaining costs are determined eligible otherwise. However, if your application is successful, those ineligible costs must be removed and replaced with eligible costs before the Agency will make the grant award, or the amount of the grant award will be reduced accordingly. If we cannot determine the percentage of ineligible costs, your application will not be considered for funding.

a. You should not submit your application in more than one format. You must submit your application electronically. Note that we cannot accept applications through mail or courier delivery, in-person delivery, email, or fax. To submit an application electronically, you must follow the instruction for this funding announcement at http://www.grants.gov. A password is not required to access the website.

All recipients under this Notice are subject to the requirements of 7 CFR part 1970. However, technical assistance awards under this Notice are classified as a Categorical Exclusion according to 7 CFR 1970.53(b), and usually do not require any additional documentation.

The Agency will review each grant application to determine its compliance with 7 CFR part 1970. The applicant may be asked to provide additional information or documentation to assist the Agency with this determination.

All grants made under this Notice are subject to Title VI of the Civil Rights Act of 1964 as required by the USDA (7 CFR part 15, subpart A) and Section 504 of the Rehabilitation Act of 1973.

The State Offices will review applications to determine if they are eligible for assistance based on requirements in 7 CFR part 4284, subparts A and F, this Notice, and other applicable Federal regulations. If determined eligible, your application will be scored by a panel of USDA employees in accordance with the point allocation specified in this Notice. Applications will be funded in rank order until the funding limitation has been reached. Applications that cannot be fully funded may be offered partial funding at the Agency's discretion.

Scoring criteria will follow criteria published at 7 CFR 4284.513 as supplemented below including any amendments made by the Section 6013 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234), which is incorporated by reference in this Notice. The regulatory and statutory criteria are clarified and supplemented below. You should also include information as described in Section D.2.e.5.vi. if you choose to address these items under the scoring criteria. Evaluators will base scores only on the information provided or cross-referenced by page number in each individual evaluation criterion. The maximum amount of points available is 110. Newly established or proposed Centers that do not yet have a track record on which to evaluate the following criteria should refer to the expertise and track records of staff or consultants expected to perform tasks related to the respective criteria. Proposed or newly established Centers must be organized well-enough at the time of application to address its capabilities for meeting these criteria.

a. Administrative capabilities (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated track record in carrying out activities in support of development assistance to cooperatively and mutually owned businesses. At a minimum, you must discuss the following administrative capabilities:

1. Financial systems and audit controls;

2. Personnel and program administration performance measures;

3. Clear written rules of governance; and

4. Experience administering Federal grant funding no later than the last 5 years, including but not limited to past RCDG awards. Please list the name of the Federal grant program(s), the amount(s), and the date(s) of funding received.

You will score higher on this criterion if you can demonstrate that the Center has independent governance. For applicants that are universities or parent organizations, you should demonstrate that there is a separate board of directors for the Center.

b. Technical assistance and other services (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated expertise no later than the last 5 years in providing technical assistance and accomplishing effective outcomes in rural areas to promote and assist the development of cooperatively and mutually owned businesses. You must discuss at least:

1. Your potential for delivering effective technical assistance;

2. The types of assistance provided;

3. The expected effects of that assistance;

4. The sustainability of organizations receiving the assistance; and

5. The transferability of your cooperative development strategies and focus to other areas of the United States.

A chart or table showing the outcomes of your demonstrated expertise based upon the performance elements listed in Section D.2.e.5.iv. or as identified in your award document on previous RCDG awards is recommended. At a minimum, please provide information for FY 2016—FY 2018 awards. You may also include any performance outcomes from an FY 2019 RCDG award. We prefer that you provide one chart or table separating out award years. The intention here is for you to provide actual performance numbers based upon award years (fiscal year) even though your grant period for the award was for the next calendar or fiscal year. Please provide a narrative explanation if you have not previously received an RCDG award.

You will score higher on this criterion if you provide more than 3 years of outcomes and can demonstrate that the organizations you assisted within the last 5 years are sustainable. Additional outcome information should be provided on RCDG grants awarded before FY 2016. Please describe specific project(s) when addressing items 1-5 of paragraph b. To reduce duplication, descriptions of specific projects and their impacts, outcomes and roles can be discussed once under criterion b or c. However, you must cross-reference the information under the other criterion.

c. Economic development (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated ability to facilitate:

1. Establishment of cooperatives or mutually owned businesses;

2. New cooperative approaches ( i.e., organizing cooperatives among underserved individuals or communities; an innovative market approach; a type of cooperative currently not in your service area; a new cooperative structure; novel ways to raise member equity or community capitalization; conversion of an existing business to cooperative ownership); and

3. Retention of businesses, generation of employment opportunities or other factors, as applicable, that will otherwise improve the economic conditions of rural areas.

You will score higher on this criterion if you provide quantifiable economic measurements showing the impacts of your past development projects no later than the last 5 years and identify your role in the economic development outcomes.

d. Past performance in establishing legal business entities (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated past performance in establishing legal cooperative business entities and other legal business entities during October 1, 2015- August 17, 2020. Provide the name of the organization(s) established, the date of formation and your role in assisting with the incorporation(s) under this criterion. In addition, documentation verifying the establishment of legal business entities must be included in Appendix C of your application and will not count against the 40-page limit for the narrative. The documentation must include proof that organizational documents were filed with the Secretary of State's Office ( i.e. Certificate of Incorporation or information from the State's official website naming the entity established and the date of establishment); or if the business entity is not required to register with the Secretary of State, a certification from the business entity that a legal business entity has been established and when. Please note that you are not required to submit articles of incorporation to receive points under this criterion. You will score higher on this criterion if you have established legal cooperative businesses. If your State does not incorporate cooperative business entities, please describe how the established business entity operates like a cooperative. Due to extenuating circumstances of COVID-19, the Agency will utilize information in the narrative to score this criterion. Documentation to verify past performance in establishing legal entities will be required before an award is made.

e. Networking and regional focus (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated commitment to:

1. Networking with other cooperative development centers, and other organizations involved in rural economic development efforts, and

2. Developing multi-organization and multi-State approaches to addressing the economic development and cooperative needs of rural areas.

You will score higher on this criterion if you can demonstrate the outcomes of your multi-organizational and multi-State approaches. Please describe the project(s), partners and the outcome(s) that resulted from the approach.

f. Commitment (maximum score of 10 points). A panel of USDA employees will evaluate your commitment to providing technical assistance and other services to under-served and economically distressed areas in rural areas of the United States. You will score higher on this criterion if you define and describe the underserved and economically distressed areas within your service area, provide economic statistics, and identify past or current projects within or affecting these areas, as appropriate. Projects identified in the work plan and budget that are located in persistent poverty counties as defined in H.R.1865—118 SEC. 740 of Further Consolidated Appropriations Act 2020, will score even higher on this criterion.

g. Matching Funds (maximum score of 10 points). A panel of USDA employees will evaluate your commitment for the 25 percent (5 percent for 1994 Institutions) matching funds requirement. A chart or table should be provided to describe all matching funds being committed to the project. However, formal documentation to verify all the matching funds must be included in Appendix A of your application. You will be scored on the total amount and how you identify your matching funds.

1. If you meet the 25 percent (5 percent for 1994 Institutions) matching funds requirement, points will be assigned as follows:

• In-kind only—1 point;

• Mix of in-kind and cash—3-4 points (maximum points will be awarded if the ratio of cash to in-kind is 30 percent or more); or

• Cash only—5 points.

2. If you exceed the 25 percent (5 percent for 1994 Institutions) matching funds requirement, points will be assigned as follows:

• In-kind only—2 points;

• Mix of in-kind and cash—6-7 points (maximum points will be awarded if the ratio of cash to in-kind is 30 percent or more); or

• Cash only—up to 10 points.

h. Work Plan/Budget (maximum score of 10 points). A panel of USDA employees will evaluate your work plan for detailed actions and an accompanying timetable for implementing the proposal. The budget must present a breakdown of the estimated costs associated with cooperative and business development activities as well as the operation of the Center and allocate these costs to each of the tasks to be undertaken. Matching funds as well as grant funds must be accounted for in the budget.

You must discuss at a minimum:

1. Specific tasks (whether it be by type of service or specific project) to be completed using grant and matching funds;

2. How customers will be identified;

3. Key personnel; and

4. The evaluation methods to be used to determine the success of specific tasks and overall objectives of Center operations. Please provide qualitative methods of evaluation. For example, evaluation methods should go beyond quantitative measurements of completing surveys or number of evaluations.

You will score higher on this criterion if you present a clear, logical, realistic, and efficient work plan and budget.

i. Qualifications of those Performing the Tasks (maximum score of 10 points). A panel of USDA employees will evaluate your application to determine if the personnel expected to perform key tasks have a track record of:

1. Positive solutions for complex cooperative development and/or marketing problems; or

2. A successful record of conducting accurate feasibility studies, business plans, marketing analysis, or other activities relevant to your success as determined by the tasks identified in the work plan; and

3. Whether the personnel expected to perform the tasks are full/part-time employees of your organization or are contract personnel.

You will score higher on this criterion if you demonstrate commitment and availability of qualified personnel expected to perform the tasks.

j. Local and Future Support (maximum score of 10 points). A panel of USDA employees will evaluate your application for local and future support. Support should be discussed directly within the response to this criterion.

1. Discussion on local support should include previous and/or expected local support and plans for coordinating with other developmental organizations in the proposed service area or with state and local government institutions. You will score higher if you demonstrate strong support from potential beneficiaries and formal evidence of intent to coordinate with other developmental organizations. You may also submit a maximum of 10 letters of support or intent to coordinate with the application to verify your discussion. These letters should be included in Appendix B of your application and will not count against the 40-page limit for the narrative. Due to extenuating circumstance of COVID-19, the Agency will utilize information in the narrative to score this criterion. Documentation to verify local support will be required before an award is made.

2. Discussion on future support will include your vision for funding operations in future years. You should document:

(i) New and existing funding sources that support your goals;

(ii) Alternative funding sources that reduce reliance on Federal, State, and local grants; and

(iii) The use of in-house personnel for providing services versus contracting out for that expertise. Please discuss your strategy for building in-house technical assistance capacity.

You will score higher if you can demonstrate that your future support will result in long-term sustainability of the Center.

k. Administrator Discretionary Points (maximum of 10 points). The Administrator may choose to award up to 10 points to an eligible non-profit corporation or institution of higher education who has never previously been awarded an RCDG grant and whose workplan and budget seeks to help rural communities build robust and sustainable economies through strategic investments in infrastructure, partnerships and innovation. Eligible applicants who want to be considered for discretionary points must discuss how their workplan and budget supports one or more of the five following key strategies:

The State Offices will review applications to determine if they are eligible for assistance based on requirements in 7 CFR part 4284, subparts A and F, this Notice, and other applicable Federal regulations. If determined eligible, your application will be scored by a panel of USDA employees in accordance with the point allocation specified in this Notice. The Administrator may choose to award up to 10 Administrator priority points based on criterion (k) in section E.1. of this Notice. These points will be added to the cumulative score for a total possible score of 110. Applications will be funded in highest ranking order until the funding limitation has been reached. Applications that cannot be fully funded may be offered partial funding at the Agency's discretion. If your application is evaluated, but not funded, it will not be carried forward into the next competition. Successful applicants must comply with requirements identified in Section F, Federal Award Administration.

If you are selected for funding, you will receive a signed notice of Federal award by postal or electronic mail from the State Office where your application was submitted, containing instructions and requirements necessary to proceed with execution and performance of the award. You must comply with all applicable statutes, regulations, and notice requirements before the grant award will be funded.

If you are not selected for funding, you will be notified in writing via postal or electronic mail and informed of any review and appeal rights. See 7 CFR part 11 for USDA National Appeals Division procedures. There will be no available funds for successful appellants once all FY 2020 funds are awarded and obligated.

Additional requirements that apply to grantees selected for this program can be found in 7 CFR part 4284, subpart F; the Grants and Agreements regulations of the Department of Agriculture codified in 2 CFR parts 180, 400, 415, 417, 418, 421; 2 CFR parts 25 and 170; and 48 CFR 31.2, and successor regulations to these parts.

In addition, all recipients of Federal financial assistance are required to report information about first-tier subawards and executive compensation (see 2 CFR part 170). You will be required to have the necessary processes and systems in place to comply with the Federal Funding Accountability and Transparency Act of 2006 (Pub. L. 109-282) reporting requirements (see 2 CFR 170.200(b), unless you are exempt under 2 CFR 170.110(b)).

The following additional requirements apply to grantees selected for awards within this program:

a. Execution of an Agency-approved Grant Agreement;

b. Acceptance of a written Letter of Conditions; and submission of the following Agency forms:

• Form RD 1940-1, “Request for Obligation of Funds.”

• Form RD 1942-46, “Letter of Intent to Meet Conditions.”

• SF LLL, “Disclosure of Lobbying Activities,” if applicable.

You no longer must complete the following five forms for acceptance of a Federal award. This information is now collected through your registration or annual recertification in SAM.gov in the Financial Assistance General Certifications and Representations section:

• Form RD 400-4, “Assurance Agreement.”

• Form AD-1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters-Primary Covered Transactions.”

• Form AD-1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion-Lower Tier Covered Transactions” if applicable.

• Form AD-1049, “Certification Regarding Drug-Free Workplace Requirements (Grants).”

• Form AD-3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.” Must be signed by corporate applicants who receive an award under this Notice. Institutions of Higher Education do not need to submit this form.

After grant approval and through grant completion, you will be required to provide an SF-425, “Federal Financial Report,” and a project performance report on a semiannual basis (due 30 working days after end of the semiannual period). The project performance reports shall include the following:

a. A comparison of actual accomplishments to the objectives established for that period;

b. Reasons why established objectives were not met, if applicable;

c. Reasons for any problems, delays, or adverse conditions, if any, which have affected or will affect attainment of overall project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular objectives during established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation; and

d. Objectives and timetable established for the next reporting period.

The grantee must provide a final project and financial status report within 90 days after the expiration or termination of the grant with a summary of the project performance reports and final deliverables in accordance to 2 CFR 200.343.

If you have questions about this Notice, please contact the appropriate State Office at http://www.rd.usda.gov/contact-us/state-offices. Program guidance as well as application and matching funds templates may be obtained at http://www.rd.usda.gov/programs-services/rural-cooperative-development-grant-program. If you want to submit an electronic application, follow the instructions for the RCDG funding announcement located at http://www.grants.gov. You may also contact National Office Program Management Division: RCDG Program Lead, cpgrants@wdc.usda.gov or call the main line at 202-720-1400.

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at How to File a Program Discrimination Complaint and at any USDA office, or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

(3) Email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

This meeting is available to the public through the following toll-free call-in number: 800-367-2403, conference ID number: 5797253. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. You may also email Ana Victoria Fortes at afortes@usccr.gov.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at https://www.facadatabase.gov/FACA/apex/FACAPublicCommittee?id=a10t0000001gzlwAAA . Please click on the “Committee Meetings” tab. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of the COVID crisis and DFO availability.

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 800-353-6461 and conference call ID number: 6813288. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call-in number: 800-353-6461 and conference call ID number: 6813288.

Members of the public are invited to make brief statements during the Public Comment section of the meeting or submit written comments. The written comments must be received in the regional office approximately 30 days after the scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Corrine Sanders at ero@usccr.gov. Persons who desire additional information may phone the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at: https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzjZAAQ; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

The Travel Promotion Act of 2009 (TPA) was signed into law on March 4, 2010 and was amended in July 2010, December 2014, and again in December 2019. The TPA established the Corporation for Travel Promotion (the Corporation), as a non-profit corporation charged with the development and execution of a plan to (A) provide useful information to those interested in traveling to the United States; (B) identify and address perceptions regarding U.S. entry policies; (C) maximize economic and diplomatic benefits of travel to the United States through the use of various promotional tools; (D) ensure that international travel benefits all States, territories of the United States, and the District of Columbia; (E) identify opportunities to promote tourism to rural and urban areas equally, including areas not traditionally visited by international travelers; and (F) give priority to countries and populations most likely to travel to the United States.

The Corporation is governed by a Board of Directors, consisting of 11 members with knowledge of international travel promotion or marketing, broadly representing various regions of the United States. The TPA directs the Secretary of Commerce (after consultation with the Secretary of Homeland Security and the Secretary of State) to appoint the Board of Directors for the Corporation.

At this time, the Department will be selecting three individuals with the appropriate expertise and experience from specific sectors of the travel and tourism industry to serve on the Board as follows:

(A) 1 shall have appropriate expertise and experience in the small business or retail sector, or in associations representing that sector;

(B) 1 shall have appropriate expertise and experience as an official of a State tourism office; and

(C) 1 shall have appropriate expertise and experience in the travel distribution services sector.

To be eligible for Board membership, individuals must have international travel and tourism marketing experience, be a current or former chief executive officer, chief financial officer, or chief marketing officer or have held an equivalent management position. Additional consideration will be given to individuals who have experience working in U.S. multinational entities with marketing budgets, and/or who are audit committee financial experts as defined by the Securities and Exchange Commission (in accordance with 15 U.S.C. 7265). Individuals must be U.S. citizens, and in addition, cannot be federally registered lobbyists or registered as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

Those selected for the Board must be able to meet the time and effort commitments of the Board.

Board members serve at the discretion of the Secretary of Commerce (who may remove any member of the Board for good cause). The terms of office of each member of the Board appointed by the Secretary shall be three (3) years. Board members can serve a maximum of two consecutive full three-year terms. Board members are not considered Federal government employees by virtue of their service as a member of the Board and will receive no compensation from the Federal government for their participation in Board activities. Members participating in Board meetings and events may be paid actual travel expenses and per diem by the Corporation when away from their usual places of residence.

Individuals who want to be considered for appointment to the Board should submit the following information by the Friday July 31, 2020 deadline to the email address listed in the ADDRESSES section above:

1. Name, title, and personal resume of the individual requesting consideration, including address, email address, and phone number.

2. A brief statement of why the person should be considered for appointment to the Board. This statement should also address the individual's relevant international travel and tourism marketing experience and audit committee financial expertise, if any, and indicate clearly the sector or sectors enumerated above in which the individual has the requisite expertise and experience. Individuals who have the requisite expertise and experience in more than one sector can be appointed for only one of those sectors. Appointments of members to the Board will be made by the Secretary of Commerce.

3. An affirmative statement that the applicant is a U.S. citizen, is not a federally-registered lobbyist and further, is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

4. If applicable, a statement acknowledging that the applicant is an audit committee financial expert as defined by the Securities and Exchange Commission (in accordance with 15 U.S.C. 7265).

On January 2, 2020, Commerce published a notice of opportunity to request an administrative review of the antidumping duty order on potassium permanganate from China. 1 On March 10, 2020, pursuant to a request from Pacific Accelerator Limited (PAL) and its affiliate Chongqing Changyuan Group Limited (Changyuan), 2 Commerce initiated an administrative review with respect to PAL and Changyuan, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b). 3 On June 9, 2020, PAL and Changyuan timely withdrew their request for an administrative review. 4 No other party requested an administrative review of these companies.

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation. PAL and Changyuan timely withdrew their review request. No other party requested an administrative review of the order for this POR. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this review in its entirety.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of potassium permanganate from China during the POR. Antidumping duties shall be assessed at rates equal to the cash deposit rate of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice in the Federal Register .

This notice serves as the only reminder to importers whose entries will be liquidated as a result of this rescission notice of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections 751 and 777(i)(1) of the Act and 19 CFR 351.213(d)(4).

The United States Travel and Tourism Advisory Board (Board) is established under 15 U.S.C. 1512 and under the Federal Advisory Committee Act, as amended, 5 U.S.C. App. (FACA). The Board advises the Secretary of Commerce on government policies and programs that affect the U.S. travel and tourism industry. The Board acts as a liaison to the stakeholders represented by the membership, consulting with them on current and emerging issues in the industry to support sustainable growth in travel and tourism.

The National Travel and Tourism Office is accepting applications for Board members. Members shall be Chief Executive Officers or senior executives from U.S. companies, U.S. organizations, or U.S. entities in the travel and tourism sectors representing a broad range of products and services, company sizes, and geographic locations. For eligibility purposes, a “U.S. company” is a for-profit firm that is incorporated in the United States (or an unincorporated U.S. firm with its principal place of business in the United States) that is controlled by U.S. citizens or by other U.S. companies. A company is not a U.S. company if 50 percent plus one share of its stock (if a corporation, or a similar ownership interest of an unincorporated entity) is known to be controlled, directly or indirectly, by non-U.S. citizens or non-U.S. companies. For eligibility purposes, a “U.S. organization” is an organization, including trade associations and nongovernmental organizations (NGOs), established under the laws of the United States, that is controlled by U.S. citizens, by another U.S. organization (or organizations), or by a U.S. company (or companies), as determined based on its board of directors (or comparable governing body), membership, and funding sources, as applicable. For eligibility purposes, a U.S. entity is a tourism-related entity that can demonstrate U.S. ownership or control, including but not limited to state and local tourism marketing entities, state government tourism offices, state and/or local government-supported tourism marketing entities, and multi-state tourism marketing entities.

Members of the Board will be selected in accordance with applicable Department of Commerce guidelines based on their ability to carry out the objectives of the Board as set forth in the Board's charter and in a manner that ensures that the Board is balanced in terms of geographic diversity, diversity in size of company or organization to be represented, and representation of a broad range of services in the travel and tourism industry. Each member shall serve for two years from the date of the appointment and at the pleasure of the Secretary of Commerce.

Members serve in a representative capacity, representing the views and interests of their particular business sector, and not as Special Government employees. Members will receive no compensation for their participation in Board activities. Members participating in Board meetings and events will be responsible for their travel, living, and other personal expenses. Meetings will be held regularly and, to the extent practical, not less than twice annually, usually in Washington, DC or virtually via teleconference.

To be considered for membership, please provide the following information to the address listed in the ADDRESSES section:

1. The name and title of the individual requesting consideration.

2. A sponsor letter from the applicant on his or her company/organization/entity letterhead or, if the applicant is to represent a company/organization/entity other than his or her employer, a letter from the company/organization/entity to be represented, containing a brief statement of why the applicant should be considered for membership on the Board. This sponsor letter should also address the applicant's travel and tourism-related experience.

3. The applicant's personal resume.

4. An affirmative statement that the applicant is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

5. If the applicant is to represent a company, information regarding the control of the company, including the stock holdings as appropriate, signifying compliance with the criteria set forth above.

6. If the applicant is to represent an organization, information regarding the control of the organization, including the governing structure, members, and revenue sources as appropriate, signifying compliance with the criteria set forth above.

7. If the applicant is to represent a tourism-related entity, the functions and responsibilities of the entity, and information regarding the entity's U.S. ownership or control, signifying compliance with the criteria set forth above.

8. The company's, organization's, or entity's size, product or service line and major markets in which the company, organization, or entity operates.

9. A brief statement describing how the applicant will contribute to the work of the Board based on his or her unique experience and perspective (not to exceed 100 words).

On January 2, 2020, Commerce published a notice of opportunity to request an administrative review of the countervailing duty order on hardwood plywood products from China. 1 On March 10, 2020, pursuant to a request from interested parties, 2 Commerce initiated an administrative review with respect to 40 companies, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b). 3 On May 7, 2020, all interested parties that requested an administrative review timely withdrew their requests. 4 No other party requested an administrative review of these companies.

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation. All interested parties timely withdrew their review requests within 90 days of the publication date of the Initiation Notice. No other party requested an administrative review of the order for this POR. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this review in its entirety.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries of hardwood plywood products from China. Countervailing duties shall be assessed at rates equal to the cash deposit rate of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice in the Federal Register .

This notice serves as the only reminder to importers whose entries will be liquidated as a result of this rescission notice, of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the presumption that reimbursement of the countervailing duties occurred and the subsequent assessment of double countervailing duties.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(d)(4).

On July 15, 2019, Commerce initiated an administrative review of the antidumping duty order on steel nails from the UAE in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). 1 This review covers one producer/exporter of the subject merchandise: Middle East Manufacturing Steel LLC (MEM). For details regarding the events that occurred subsequent to the initiation of the review, see the Preliminary Decision Memorandum. 2

Pursuant to section 751(a)(3)(A) of the Act, Commerce determined that it was not practicable to complete the preliminary results of this review within 245 days and extended the deadline for issuance of the preliminary results by 119 days, until May 29, 2020. 3 On April 24, 2020, Commerce tolled the deadlines in all ongoing administrative reviews by 50 days. 4

The products covered by this order are steel nails from the UAE. For a full description of the scope, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a) of the Act. Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum. A list of topics included in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum is available at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

We preliminarily determine that the following weighted-average dumping margin exists for the respondent for the period May 1, 2018 through April 30, 2019:

Upon completion of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries. If MEM's weighted-average dumping margin is not zero or de minimis ( i.e., less than 0.5 percent) in the final results of this review, we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). We intend to instruct CBP to assess antidumping duties on all appropriate entries covered by this review where the importer-specific assessment rate calculated in the final results of this review is not zero or de minimis. If MEM's weighted-average dumping margin is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties, where applicable. 5

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by MEM where MEM did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. 6

We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the finals results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for MEM will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rates published for the most recently-completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered by this review, a prior review, or the original investigation but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 4.30 percent, 7 the all-others rate established in the less-than-fair-value investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results. 8 Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than seven days after the date for filing case briefs. 9 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue, (2) a brief summary of the argument, and (3) a table of authorities. 10 Case and rebuttal briefs should be filed using ACCESS  11 and must be served on interested parties. 12 Executive summaries should be limited to five pages total, including footnotes. Note that Commerce has modified certain of its requirements for serving documents containing business proprietary information, until July 17, 2020, unless extended. 13

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

Coonamessett Farm Foundation (CFF) submitted a complete application for an Exempted Fishing Permit (EFP) on April 28, 2020, that would allow gear research to be conducted by vessels on compensation fishing trips associated with projects funded by the 2020 Scallop Research Set-Aside (RSA) Program. The exemptions would allow 20 participating commercial fishing vessels to exceed the crew size regulations at 50 CFR 648.51(c) to place a researcher on the vessel and temporarily exempt the participating vessels from possession limits and minimum size requirements specified in 50 CFR part 648, subparts B and D through O, for biological sampling purposes. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited, including landing fish in excess of a possession limit or below the minimum size.

Experimental fishing activity would test a one-way extended link dredge gear modification to reduce flatfish bycatch and catch of pre-recruit scallops in the scallop dredge fishery. Any modification would comply with existing scallop gear regulations. All trips would take place in scallop open access areas of southern New England and scallop fishing areas open to scallop RSA compensation fishing.

The exemption from crew size limits is needed because a research technician would accompany vessels on the compensation fishing trips to collect catch data associated with the dredge modifications. The crew size exemption would be for approximately 120 days-at-sea and must be used in conjunction with a valid compensation fishing letter of authorization. The technician would only engage in data collection activities and would not process catch to be landed for sale. Exemption from possession limit and minimum sizes would support catch sampling activities and ensure the vessel is not in conflict with possession regulations while collecting catch data. All catch above a possession limit or below a minimum size would be discarded as soon as possible following data collection. The proposed gear modifications are not expected to increase catch above typical commercial fishing practices and gears. All research trips would otherwise be consistent with normal commercial fishing activity and catch would be retained for sale.

If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

The Ecosystem-Based Fishery Management (EBFM) Committee will receive, review, and provide feedback on additional public outreach materials prepared by Green Fin Studio. The Committee will receive a draft plain language document on a worked example based on the Hydra operating model. They will also discuss and provide guidance on the framework and focus of public outreach workshops to be conducted during October to December. Other business will be discussed as necessary

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

Public comments: Mail to Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Mill #2, Newburyport, MA 01950. Mark the outside of the envelope “DEIS for Amendment 23 to the Northeast Multispecies FMP”. Comments may also be sent via fax to (978) 465-3116 or submitted via email to comments@nefmc.org with “DEIS for Amendment 23 to the Northeast Multispecies FMP” in the subject line.

Scheduling of hearings is ongoing due to the COVID-19 pandemic. Additional hearings will be announced in a separate notice. Council staff will brief the public on Draft Amendment 23 before receiving comments on the amendment. The hearing will begin promptly at the time indicated above. If all attendees who wish to do so have provided their comments prior to the end time indicated, the hearing may conclude early. To the extent possible, the Council may extend hearings beyond the end time indicated above to accommodate all attendees who wish to speak.

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

The Mid-Atlantic Fishery Management Council will meet via webinar on July 16, 2020 to review alternatives, related analyses, Committee recommendations, and take final action on the Mackerel, Squid, Butterfish FMP Goals/Objectives, and Illex Permits Amendment. Details and briefing materials will be posted to https://www.mafmc.org/briefing/july-2020.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

Appeals to the PTAB are normally taken up for decision in the order in which they are docketed. See USPTO Standard Operating Procedure 1 (Sept. 20, 2018), available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/resources. However, a small number of appeals are advanced out of turn due to a special status. For example, reexamination proceedings, which are handled by the USPTO with “special dispatch,” and reissue applications are treated as special throughout their pendency, including during appeal. See Manual of Patent Examining Procedure (MPEP) 708.01. Applications that have been “made special” during examination through a petition based on the age or health of an applicant, or for other reasons listed in 37 CFR 1.102 (a)-(d), also maintain their special status through any appeal. See MPEP 1203(II). Furthermore, for the same reasons, an appellant may also petition the PTAB to have an application on appeal made special. See id. Currently, about 1.1% of appeals are given a special status through one of the above methods.

The America Invents Act created a mechanism for the prioritized examination of patent applications, which permits an applicant to advance an application out of turn ( i.e., accord special status) for examination by filing a request accompanied by the appropriate fees. See Changes to Implement the Prioritized Examination Track (Track I) of the Enhanced Examination Timing Control Procedures Under the Leahy-Smith America Invents Act, 76 FR 59050 (Sept. 23, 2011) (Track I Notice). In view of the program's popularity and high demand, the USPTO recently increased the yearly number of requests that may be granted from 10,000 to 12,000. See Increase of the Annual Limit on Accepted Requests for Track I Prioritized Examination, 84 FR 45907 (Sept. 3, 2019). In FY 2019, prioritized examination was granted for approximately 2.7% of the total number of applications filed. Prioritized examination status, however, does not carry through to any appeal from a final rejection. See 76 FR 59051.

In view of the success and popularity of prioritized examination, the PTAB is adopting, on a temporary basis, the Fast-Track Appeals Pilot Program, under which an appellant may have any ex parte appeal to the PTAB accorded fast-track status by filing a petition accompanied by a fee. Under the Pilot Program, the PTAB will endeavor to issue a decision on an ex parte appeal within six months from the date the appeal is entered into the program. Currently, the average appeal pendency is about 15 months. See PTAB Statistics, available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/statistics. Thus, fast-track decisions on ex parte appeals under this Pilot Program may hasten patentability determinations on new inventions and the pace at which products or services embodying these inventions are brought to the marketplace, thus spurring follow-on innovation, economic growth, and job creation.

The Fast-Track Appeals Pilot Program will accept petitions for advancing out of turn and according fast-track status to ex parte appeals for up to one year from the effective date of the program or until 500 appeals have been accorded fast-track status under the program, whichever occurs earlier. The threshold of 500 granted petitions corresponds to approximately 8% of the total number of new appeals received in the average fiscal year and was chosen in accordance with maintaining the PTAB's overall decision pendency goals.

The USPTO will evaluate the Pilot Program at the conclusion of this one-year period or 500-appeal threshold to determine if it should be made permanent. Likewise, the USPTO will consider what changes, if any, would be required to provide a sustainable mechanism for some number of ex parte appeals to be advanced out of turn without adversely affecting the timeliness of providing decisions on the other appeals before the PTAB.

If the USPTO finds that the Fast-Track Appeals Pilot Program adversely impacts the pendency of other appeals at any point in time during the program's operation, then the USPTO may modify or terminate the Pilot Program. Moreover, if the Pilot Program is not sufficiently used, it may be modified or terminated.

The PTAB will accord fast-track status to a pending ex parte appeal in accordance with the following conditions:

(1) The application must be an original utility, design, or plant nonprovisional application. The Fast-Track Appeals Pilot Program is not available for applications or proceedings that are already treated as special during appeal, such as reissue applications, reexamination proceedings, appeals made special due to the age or health of an applicant, or appeals subject to any other pilot program that advances an appeal out of turn. See MPEP 708.01 for a complete list of cases that are treated as special.

A petition under 37 CFR 41.3 must be filed in the application involved in the ex parte appeal for which fast-track status is sought and must identify that application and appeal by application number and appeal number, respectively. See MPEP 502.05. The petition may be submitted via: (1) The USPTO patent electronic filing systems (EFS-Web or Patent Center); (2) the U.S. Postal Service by Priority Mail Express under 37 CFR 1.10 or with a certificate of mailing under 37 CFR 1.8; or (3) hand-delivery to the USPTO Customer Service Window (MPEP 501). Electronic submission of a petition is preferred for faster petition processing. In addition, the appeal for which fast-track status is sought must be an appeal for which a notice of appeal has been filed under 37 CFR 41.31 and an appeal docketing notice has been mailed by the PTAB.

The USPTO has created a form-fillable Portable Document Format (PDF) “Petition—Fast-Track Appeals Pilot Program” (Form PTO/SB/451) for use in filing a certification and petition under 37 CFR 41.3 for the Fast-Track Appeals Pilot Program. Form PTO/SB/451 is available on the USPTO's website ( http://www.uspto.gov/patent/patents-forms ). Form PTO/SB/451 does not collect “information” within the meaning of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). See 5 CFR 1320.3(h). Therefore, this notice does not involve information collection requirements that are subject to review by the Office of Management and Budget. Appellants are recommended to use, but are not required to use, Form PTO/SB/451 when petitioning for entry into the Fast-Track Appeals Pilot Program. Any petition filed by any means other than Form PTO/SB/451 must still contain the required information.

The petition under 37 CFR 41.3 must be signed by an applicant who is prosecuting the applicant's own case under 37 CFR 1.31 (except that a juristic entity must be represented by a registered practitioner even if the juristic entity is the applicant), a registered practitioner who has a power of attorney under 37 CFR 1.32, or a registered practitioner who has authority to act under 37 CFR 1.34, in order for the application involved in the appeal to be accorded fast-track status.

A petition fee of $400 under 37 CFR 41.20(a) is required at the time the petition is filed. Due to statutory limitations on fee collection, the USPTO may not refund the petition fee once collected. See 35 U.S.C. 42(d) and 37 CFR 1.26(a) (permits refunds only for fees “paid by mistake or any amount paid in excess of that required”). Thus, no refund will be granted for any petition that does not meet the requirements set forth above and/or is not granted for any other reason.

One purpose of the Fast-Track Appeals Pilot Program is to gauge the public's interest in the ability to obtain a speedier resolution of an ex parte appeal. The number of granted petitions in the Fast-Track Appeals Pilot Program during the one-year program period is limited to 125 granted petitions per quarter, and a total of 500 granted petitions. A “quarter” under this Pilot Program is defined as a three-month period measured from the applicability date of this Notice. For example, if this Notice has an applicability date of June 1, then a “quarter” under this Pilot Program spans the three months from June 1 to August 31.

The thresholds of 125 and 500 granted petitions have been chosen to allow for robust participation in the Fast-Track Appeals Pilot Program without compromising the PTAB's ability to deliver on other appeal pendency goals. The limit of 500 granted petitions corresponds to approximately 8% of the total number of new appeals received in the average fiscal year. If the Pilot Program adversely impacts the pendency of other appeals, then the USPTO may modify or terminate the Pilot Program. Additionally, if the Pilot Program is not sufficiently used, it may be modified or terminated.

Petitions for entry into the Fast-Track Appeals Pilot Program will be decided in the order they are received. Petitions meeting the requirements listed above for entry into the Pilot Program will be granted, and the petitioner will be notified by a decision granting the petition to accord fast-track status. Petitions not meeting the requirements listed above for entry into the Pilot Program will be denied, and the petitioner will be notified of a decision denying the petition. A petitioner may reapply if a first petition is denied. Any second petition filed by a petitioner for the same application and same appeal covered by a first, failed petition will not be accorded the filing date of the first petition for purposes of determining whether the second petition fell within the thresholds of 125 or 500 granted petitions.

The PTAB will communicate the number of granted petitions for fast-track appeal via the PTAB website, www.uspto.gov/PTABFastTrack, and appellants should take this information into account when deciding whether to file a petition. Consequently, appellants should consult the PTAB's website for information on the status of the Fast-Track Appeals Pilot Program.

The PTAB may also exercise discretion to grant a small number of petitions in excess of the thresholds of 125 and 500 granted petitions in a given quarter or for the year, respectively. Should a significant number of petitions exceeding the quarterly threshold of 125 granted petitions be filed in a quarter, those petitions may be held in abeyance and decided, in order of receipt, in the subsequent quarter. An appeal for which a petition is held in abeyance will not be accelerated unless and until the petition is granted in the subsequent quarter.

The goal for rendering a decision on the petition to accord fast-track status to an ex parte appeal is no later than one month from the filing date of the petition. The goal for rendering a decision on the ex parte appeal is no later than six months from the date an appeal is entered into the program, which occurs when a petition to accord fast-track status to the appeal is granted.

A petition may be filed anytime between (1) the date when the PTAB issues a notice that the appeal has been docketed to the PTAB, and (2) the date at which the appellant withdraws the appeal, a final decision is rendered by the PTAB under 37 CFR 41.50, or PTAB jurisdiction ends under 37 CFR 41.35. Petitions for fast-track status may be filed for ex parte appeals regardless of whether the appeal is newly docketed or was docketed previously. If the petition complies with the formal requirements ( e.g., signature, identification of application) and is accompanied by the required fee, the appeal will be given fast-track status in accordance with current procedures, including the quarterly and overall program thresholds described above.

Inclusion in the Fast-Track Appeals Pilot Program may be requested for ex parte appeals in which the appellant seeks an oral hearing before the PTAB (“heard” appeals), as well as those appeals for which no oral hearing is requested (“on-brief” appeals). Hearings in ex parte appeals accorded fast-track status under the Pilot Program will be conducted according to the ordinary PTAB hearing procedures. Appellants seeking an oral hearing should submit with the request for oral hearing any preferences as to the time, date, or location of the hearing. The PTAB will make its best efforts to schedule a hearing in accordance with such preferences, consistent with the goals of the Pilot Program. If the PTAB is unable to accommodate an appellant's preferences, it will schedule the hearing in an available hearing room at any office, including a regional office, and at a time and date best suited to meeting the goals of the Pilot Program. If no such hearing room is available, the PTAB will schedule a hearing to be conducted by videoconference or telephone.

Because an appellant seeks a faster decision and hearing room availability is limited, an appellant in an ex parte appeal accorded fast-track status may not seek to relocate (to a different office) the hearing after receiving a Notice of Hearing. An appellant who does not wish to attend the hearing at the designated location may, however, request to attend the hearing by videoconference or telephone, in accordance with current PTAB hearing procedures. An appellant may also waive the hearing and continue under the Fast-Track Appeals Pilot Program for consideration and decision on the briefs.

An appellant may not reschedule the date or time of a hearing and remain in the Fast-Track Appeals Pilot Program. If an appellant in an ex parte appeal accorded fast-track status must reschedule the date or time of a hearing and is not willing to waive the oral hearing, then the appellant may opt out of the Fast-Track Appeals Pilot Program, thereby regaining the ability to reschedule or relocate the hearing as per ordinary PTAB hearing procedures. If an appellant opts out of the Fast-Track Appeals Pilot Program for purposes of rescheduling the date of a hearing, the appellant will not be entitled to a refund of the petition fee.

Fast-track status will be maintained in an ex parte appeal from the date at which the petition for inclusion in the Fast-Track Appeals Pilot Program is granted until the PTAB's jurisdiction ends under 37 CFR 41.35(b). Activities subsequent to an appellant's withdrawal from the Pilot Program or the PTAB's decision, including any reopened prosecution, will not be treated as subject to fast-track status, nor will filing a petition for inclusion in the Fast-Track Appeals Pilot Program cause an application to be accorded fast-track status outside the jurisdiction of the PTAB. Additionally, any request by an appellant causing a delay in the conduct of the appeal, such as for an extension of time under 37 CFR 1.136(b), or for additional briefing, will be cause for removal of fast-track status without refund of the petition fee.

The Fast-Track Appeals Pilot Program is being adopted on a temporary basis until July 2, 2021 or 500 appeals have been accorded fast-track status under the Fast-Track Appeals Pilot Program, whichever occurs earlier. The USPTO may extend the Fast-Track Appeals Pilot Program (with or without modification) on either a temporary or a permanent basis or may discontinue the Pilot Program for adversely interfering with the timely processing of other appeals or insufficient usage. The USPTO will notify the public when the threshold of 500 granted petitions for the Fast-Track Appeals Pilot Program is about to be reached, and with any further relevant information, on the PTAB website at www.uspto.gov/PTABFastTrack.

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

The following products are proposed for deletion from the Procurement List:

Title; Associated Form, and OMB Number: AF E.O. IT Systems—Entellitrack and iComplaints; AF FORM 1271, Equal Opportunity Record of Assistance/Contact; AF FORM 1587, Military Equal Opportunity Formal Complaint Summary; AF FORM 1587-1, Military Equal Opportunity Informal Complaint Summary; OMB Control Number 0701-XXXX.

Type of Request: New.

Number of Respondents: 530.

Responses per Respondent: 1.

Annual Responses: 530.

Average Burden per Response: 2 hours.

Annual Burden Hours: 1,060 hours.

Needs and Uses: The information collection requirement is necessary for the purpose of counseling, processing, investigating and adjudicating complaints of unlawful discrimination brought by AF applicants, former AF employees, contractors, retirees, and military dependents. Particularly, the information is used to investigate and resolve complaints of unlawful discrimination and sexual harassment under the AF Equal Opportunity Program; and to maintain records created as a result of the filing of allegations and appeals involving unlawful discrimination because of race, color, religion, sex, national origin, age, physical/mental disability, or genetic information.

Affected Public: Individuals or households.

Frequency: On occasion.

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: Continued Health Care Benefit Program, DD Form 2837; OMB Control Number 0720-XXXX (formerly 0704-0364).

Type of Request: Reinstatement.

Number of Respondents: 1,475.

Responses per Respondent: 1.

Annual Responses: 1,475.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 369.

Needs and Uses: The information collection requirement is necessary for individuals to apply for enrollment in the continued Health Care Benefit Program (CHCBP). The CHCBP is a program of temporary health care benefit coverage that is made available to eligible individuals who lose health care coverage under the Military Health System (MHS).

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Mr. Josh Brammer.

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.

The Breton SD is proposed to be located on the east bank of the Mississippi River, at approximately 68 miles above “Head of Passes” and south of the Towns of Braithwaite and Scarsdale, in Plaquemines Parish, Louisiana. The requested Federal action associated with the Breton SD is authorization of the discharge of dredged or fill material into the Waters of the United States (Section 404) and the construction of structures and/or work that may affect navigable waters (Section 10), and permission to use, occupy, and alter Corps' Civil Works projects (Section 408) through the issuance of a DA Section 10/404 permit and Section 408 permission. Based on the potential impacts, both individually and cumulatively, Federal authorization for the proposed Action would constitute a “major federal action”. The Corps intends to prepare an Environmental Impact Statement (EIS) in compliance with the National Environmental Policy Act (NEPA) as part of its decision-making process before rendering a decision on CPRA's permit application. The Corps' decision will be to issue, issue with modification, or deny the requested DA permit/permissions for the proposed Action. The EIS will assess the potential effects of the proposed Breton SD on the human environment (including the natural and physical environment and relationship of people with that environment) and is intended to be sufficient in scope to address Federal, State, and local requirements and permit reviews, and environmental and socioeconomic issues concerning the proposed Action. The CEMVN DA permit number for the Breton SD is MVN-2018-1120-EOO.

1. Project Details. The proposed Breton SD Project is a large-scale, complex ecosystem restoration project intended to convey sediment, fresh water, and nutrients from the Mississippi River into the Breton Sound Basin in an effort to reduce coastal land loss and sustain surrounding wetlands. If constructed and operated as proposed, CPRA would maintain a base flow up to 5,000 cubic feet per second (cfs) through the Breton SD Structure. When the Mississippi River gage at Belle Chasse exceeds 450,000 cfs in flow, the Breton SD structure would “open” to divert varying volumes of sediment, fresh water, and nutrients into the Breton Sound Basin. Maximum discharge of the Breton SD Structure would be 75,000 cfs, reached when the Belle Chasse gage measures 1,000,000 cfs.

The proposed Breton SD gated intake would impact the Mississippi River batture on the east bank, or left descending bank, of the Mississippi River, at approximately 68 miles above “Head of Passes” and extend eastward, with the conveyance structure and guide levees extending through the Mississippi River Levee, Louisiana Highway 39, and the non-Federal back levee south of the Towns of Braithwaite and Scarsdale, Louisiana. The Breton SD structure would terminate at the outfall channel which would initially widen to convey sediment, fresh water, and nutrients into Breton Sound Basin with a pilot channel connecting to River Aux Chenes.

If constructed as proposed, the Breton SD footprint would directly impact approximately 309 acres of jurisdictional wetlands and approximately 52 acres of waters of the U.S. The proposed Breton SD operation will result in additional impacts, to the Breton Sound Basin where the current landscape is expected to be altered via diversion-related processes such as channelization, accretion, and delta formation. According to CPRA, the area to be potentially impacted within the Breton Sound Basin encompasses 5,277 acres of existing jurisdictional wetlands and 2,225 acres of waters of the U.S.

The Corps requires compensatory mitigation to offset unavoidable impacts to jurisdictional wetlands and other aquatic resources. CPRA proposes this project as a large scale ecosystem restoration that is self-mitigating. CEMVN will assess whether compensatory mitigation is required as part of the EIS process and permit review.

The proposed Breton SD project would directly and/or indirectly impact multiple CEMVN Civil Works projects, including but not limited to projects within the Mississippi Rivers and Tributaries Program such as the Mississippi River Levee and the Mississippi River (federal navigation) Ship Channel.

CPRA submitted a complete joint permit application to CEMVN and the Louisiana Department of Natural Resources for the proposed Breton SD on March 11, 2019; it was advertised on joint public notice on March 19, 2019. Following a review of the permit application, joint public notice comments, related sediment diversion sources, and based on a preliminary assessment of the environmental impacts, CEMVN determined that an EIS is required due to the proposed Action's potential to significantly impact the quality of the human environment on July 31, 2019. Since that decision, an independent third-party contractor was selected to draft the EIS on behalf of CEMVN, and CEMVN, CPRA, and the Cooperating Agencies (identified below), developed the proposed Breton SD purpose and need (identified in the following paragraph), selected hydraulic modeling inputs and parameters, and identified a preliminary range of alternatives (identified below).

The established Breton SD purpose and need is as follows: The purpose of the proposed Action is to reconnect and re-establish the deltaic sediment deposition process between the Mississippi River and the Breton Sound Basin through a large-scale sediment diversion that is consistent with the Louisiana Coastal Master Plan (LCMP) and delivers sediment, freshwater, and nutrients to create, preserve, restore, and sustain wetlands to counteract the effects of natural and man-made disturbances, such as the Deep Water Horizon oil spill. The proposed Action is needed to serve as a long-term, resilient, sustainable strategy to reduce land loss rates and sustain and restore wetlands altered by natural and man-made disturbances in the Breton Sound Basin.

2. Scoping Process. Public Scoping meetings will be held virtually, accessible by phone and internet. The Corps invites all affected federal, state, and local agencies, affected Native American Tribes, other interested parties, and the general public to participate in the NEPA process during development of the EIS. The purpose of the public scoping process is to provide information to the public, narrow the scope of analysis to significant environmental issues, serve as a mechanism to solicit agency and public input on alternatives and issues of concern, and ensure full and open participation in scoping for the Draft EIS. To ensure that all the issues related to the proposed Breton SD are addressed, the Corps will conduct virtual public scoping meeting(s) to which agencies, organizations, and members of the general public are invited to present comments or suggestions with regard to the range of actions, alternatives, and potential impacts to be considered in the EIS. Project and public scoping meeting information, including information as to where, when, and how to participate and submit scoping comments as well as other opportunities for public involvement, will be available on CEMVN's website at: https://www.mvn.usace.army.mil/Missions/Regulatory/Permits/Mid-Breton-Sediment-Diversion-EIS/ and http://www.mvn.usace.army.mil/Missions/Regulatory/Public-Notices/. Notification of Breton SD virtual scoping meetings will also be available via press releases, special public notices, and on CEMVN's social media platforms.

3. Federal Authority. The EIS will disclose the context and intensity of environmental impacts, including direct, indirect, and cumulative impacts, of the proposed Action as required under the Council of Environmental Quality's (CEQ) National Environmental Policy Act (NEPA) regulations at 40 CFR parts 1500-1508 and the Department of the Army's (DA) NEPA regulations at 33 CFR part 325, appendix B. A reasonable range of alternatives will be determined and significant issues related to the proposed Action will be identified during agency and public scoping. As explained below, a preliminary range of alternatives has been developed. The EIS will address the Public Interest Review requirements of the DA permitting process (33 CFR parts 320-332), as well as the requirements of the Clean Water Act Section 404(b)(1) guidelines (40 CFR part 230). The EIS will inform the CEMVN decision-making processes for Section 10 (33 U.S.C. 403), Section 404 (33 U.S.C. 1344), and Section 408 (33 U.S.C. 408).

Under Section 10/Section 404, the District Engineer issues permits for the discharge of dredged and/or fill material into the waters of the U.S. and for work in navigable water in the U.S., to include installation and maintenance of structures based on the public interest review and Section 404(b)(1) Clean Water Act guidelines.

Under Section 408, the Corps of Engineers reviews requests to use, occupy, alter or modify existing Corps of Engineers projects. The decision whether to grant a Section 408 permission for such use, occupation or alteration is based on whether the proposed Action would be injurious to the public interest and whether it would impair the usefulness of affected Corps of Engineers projects.

The proposed Action is subject to Executive Order 13807 of August 15, 2017 titled “Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects” and Title 41 of the Fixing America's Surface Transportation Act (FAST-41) (42 U.S.C. 4370m, et seq. ). Project milestones established via a Coordinated Project Plan will be maintained and updated quarterly on the Federal Permitting Dashboard. Interested parties can monitor project milestones at: https://www.permits.performance.gov/permitting-projects/mid-breton-sediment-diversion.

At this time, Cooperating Agencies on the EIS include the: Environmental Protection Agency (EPA), Department of Interior's U.S. Fish and Wildlife Service (USFWS), National Oceanic and Atmospheric Administration's National Marine Fisheries Service (NMFS), U.S. Department of Agriculture's Natural Resources Conservation Service (NRCS), U.S. Coast Guard (USCG), Advisory Council on Historic Preservation (ACHP), Louisiana's Historic Preservation Office (SHPO), and Louisiana's Department of Transportation and Development (LADOTD).

4. Alternatives. The EIS will address a reasonable range of alternatives based on the proposed Breton SD's purpose and need. CEMVN, through consultation with Cooperating Agencies and CPRA, has identified a preliminary range of alternatives to evaluate in greater detail in the EIS. Prospective alternatives were developed from, but not limited to, Breton SD public notice comments, Mid-Barataria Sediment Diversion scoping comments, existing studies prepared under the Coastal Wetlands Planning, Protection, and Restoration Act (CWPPRA) Program and Louisiana Coastal Area (LCA) Program, including the LCA Medium Diversion at Myrtle Grove with Dedicated Dredging Feasibility Study and the LCA Medium Diversion at White Ditch Feasibility Study, and the 2017 Louisiana Coastal Master Plan. CEMVN's preliminary range of alternatives is a sediment diversion with maximum flows of 35,000 cfs, 75,000 cfs (CPRA's preferred alternative), and 115,000 cfs. Each of the three sediment diversion alternatives will be evaluated with two base flow alternatives, 2,500 cfs and 5,000 cfs. Other reasonable alternatives may be developed based on comments received through the NEPA scoping process.

5. Potentially Significant Issues. The EIS will analyze the potential impacts on the human and natural environment resulting from the project. The scoping, public involvement, and interagency coordination processes will help identify and define the range of potential significant issues that will be considered. Important resources and issues to be evaluated in the EIS could include, but are not limited to, the direct, indirect, and cumulative effects on tidal wetlands and other waters of the U.S.; aquatic resources; commercial and recreational fisheries; wildlife resources; essential fish habitat; water quality; cultural resources; geology and soils including agricultural land and prime and unique farmland; hydrology and hydraulics; air quality; marine mammals; threatened and endangered species and their critical habitats; navigation and navigable waters; induced flooding; employment and incomes; land use; property values; tax revenues; population and housing; community and regional growth; environmental justice; community cohesion; public services; recreation; transportation and traffic; utilities and community service systems; and cumulative effects of related projects in the study area.

6. Environmental Consultation and Review. The proposed Action is being coordinated with a number of federal, state, regional, and local agencies. In accordance with relevant environmental laws and regulations, CEMVN will consult with the following agencies: USFWS under the Fish and Wildlife Coordination Act; USFWS and NMFS under the Endangered Species Act; NMFS under the Magnuson-Stevens Fishery Conservation and Management Act; and, the ACHP, Louisiana SHPO, and the appropriate Tribal Historic Preservation Officers under the National Historic Preservation Act and integrated NHPA/EIS process.

On March 15, 2018, NMFS issued a Marine Mammal Protection Act (MMPA) waiver pursuant to Title II, Section 20201 of the Bipartisan Budget Act of 2018 and Section 101(a)(3)(A) of the MMPA for the Mid-Barataria Sediment Diversion, Mid-Breton Sound Sediment Diversion, and Calcasieu Ship Channel Salinity Control Measures.

7. Availability. The draft EIS is presently scheduled to be available for public review and comment on November 9, 2022. All comments received throughout the review process will become part of the project file for the proposed Breton SD project and will be subject to public release.

Purpose: In accordance with the Government in the Sunshine Act (Sunshine Act), Public Law 94-409, as amended (5 U.S.C. 552b), the U.S. Election Assistance Commission (EAC) will conduct a virtual annual meeting of the EAC Standards Board to discuss the proposed Voluntary Voting System Guidelines (VVSG) 2.0 Requirements as submitted by the Technical Guidelines Development Committee (TGDC).

Agenda: The U.S. Election Assistance Commission (EAC) Standards Board will hold their 2020 Annual Meeting primarily to discuss the proposed VVSG 2.0 Requirements. This meeting will include a question and answer discussion between board members. Staff from NIST and the EAC will be available to answer questions, and provide information on the VVSG process and the proposed VVSG 2.0 Requirements.

Board members will also review FACA Board membership guidelines and policies with EAC Associate Counsel and receive a general update about the EAC from the Executive Director. The Board will also elect a new member to the Executive Board Committee and consider amendments to the Bylaws.

Background: The VVSG 2.0 Requirements were published for a 90-day public comment period that concluded on June 22, 2020. The first VVSG public hearing on March 27, 2020 covered an introduction to the VVSG process as well a high-level overview of the proposed VVSG 2.0 requirements. A recording of the hearing is available on the EAC's website. The second public hearing on May 6, 2020 addressed the importance of VVSG 2.0 at the state and local level, and the consideration of accessibility and security in VVSG 2.0. A recording of the second hearing is available on the EAC's website. The third public hearing on May 20, 2020 included discussions with voting system manufacturers and voting system testing labs. A recording of the third hearing is available on the EAC's website. The EAC Board of Advisors held their annual meeting to discuss the VVSG 2.0 on June 16, 2020. A recording of the hearing is available on the EAC's website.

The TGDC unanimously approved to recommend VVSG 2.0 Requirements on February 7, 2020, and sent the Requirements to the then EAC Acting Executive Director via the Director of the National Institute of Standards and Technology (NIST), in the capacity of the Chair of the TGDC on March 9, 2020. Upon adoption, the VVSG 2.0 would become the fifth iteration of national level voting system standards. The Federal Election Commission published the first two sets of federal standards in 1990 and 2002. The EAC then adopted Version 1.0 of the VVSG on December 13, 2005. In an effort to update and improve version 1.0 of the VVSG, on March 31, 2015, the EAC commissioners unanimously approved VVSG 1.1.

The full agenda will be posted in advance on the EAC website: https://www.eac.gov.

Status: This hearing will be open to the public.

The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

As part of its continuing effort to reduce paperwork burdens, and as required by the PRA of 1995 (44 U.S.C. 3501-3520), the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; 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; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-1208.

Title: Acceleration of Broadband Deployment by Improving Wireless Facilities Siting Policies.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or households, business or other for-profit entities, not-for-profit institutions and State, local or Tribal governments.

Number of Respondents: 1,350 respondents; 3,597 responses.

Estimated Time per Response: .5 hours to 1 hour.

Frequency of Response: Third-party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in Sections 1, 2, 4(i), 7, 201, 301, 303, and 309 of the Communications Act of 1934, as amended, and Sections 6003, 6213, and 6409(a) of the Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112-96, 126 Stat. 156, 47 U.S.C. 151, 152, 154(i), 157, 201, 301, 303, 309, 1403, 1433, and 1455(a).

Total Annual Burden: 3,535 hours.

Total Annual Cost: None.

Privacy Impact Assessment: This information collection may affect individuals or households. However, the information collection consists of third-party disclosures in which the Commission has no direct involvement. Personally identifiable information (PII) is not being collected by, made available to, or made accessible by the Commission. There are no additional impacts under the Privacy Act.

Nature and Extent of Confidentiality: No known confidentiality between third parties.

Needs and Uses: This information collection will be submitted for extension to the Office of Management and Budget (OMB) after the 60-day comment period to obtain the full three-year clearance. The Commission has not changed the collection, which includes disclosure requirements pertaining to subpart CC of part 1 of the Commission's rules. This Subpart was adopted to implement and enforce Section 6409(a) of the Middle Class Tax Relief and Job Creation Act of 2012. Section 6409(a) provides, in part, that “a State or local government may not deny, and shall approve, any eligible facilities request for a modification of an existing wireless tower or base station that does not substantially change the physical dimensions of such tower or base station.” 47 U.S.C. 1455(a)(1). In subpart CC, the Commission adopted definitions of ambiguous terms, procedural requirements, and remedies to provide guidance to all stakeholders on the proper interpretation of the provision and to enforce its requirements, reducing delays in the review process for wireless infrastructure modifications and facilitating the rapid deployment of wireless infrastructure.

The following are the information collection requirements in connection with subpart CC of part 1 of the Commission's rules:

• 47 CFR 1.40001(c)(3)(i)—To toll the 60-day review timeframe on grounds that an application is incomplete, the reviewing State or local government must provide written notice to the applicant within 30 days of receipt of the application, clearly and specifically delineating all missing documents or information. Such delineated information is limited to documents or information meeting the standard under paragraph (c)(1) of § 1.140001.

• 47 CFR 1.140001(c)(3)(iii)—Following a supplemental submission from the applicant, the State or local government will have 10 days to notify the applicant in writing if the supplemental submission did not provide the information identified in the State or local government's original notice delineating missing information. The timeframe for review is tolled in the case of second or subsequent notices of incompleteness pursuant to the procedures identified in paragraph (c)(3). Second or subsequent notices of incompleteness may not specify missing documents or information that were not delineated in the original notice of incompleteness.

• 47 CFR 1.140001(c)(4)—If a request is deemed granted because of a failure to timely approve or deny the request, the deemed grant does not become effective until the applicant notifies the applicable reviewing authority in writing after the review period has expired (accounting for any tolling) that the application has been deemed granted.

These collections are necessary to effectuate the rule changes that implement and enforce the requirements of Section 6409(a).

The BDAC meeting is open to the public on the internet via live feed from the FCC's web page at http://www.fcc.gov/live. Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to fcc504@fcc.gov or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation needed. In addition, please include a way for the FCC to contact the requester if more information is needed to fill the request. Please allow at least five days' advance notice for accommodation requests; last minute requests will be accepted, but may not be possible to accommodate. Oral statements at the meeting by parties or entities not represented on the BDAC will be permitted to the extent time permits, at the discretion of the BDAC Chair and the DFO. Members of the public may submit comments to the BDAC in the FCC's Electronic Comment Filing System, ECFS, at www.fcc.gov/ecfs. Comments to the BDAC should be filed in Docket 17-83.

Proposed Agenda: At this meeting, the BDAC will hear reports from the Increasing Broadband Investment in Low-Income Communities, Broadband Infrastructure Deployment Job Skills and Training Opportunities, and Disaster Response and Recovery working groups. This agenda may be modified at the discretion of the BDAC Chair and the Designated Federal Officer (DFO).

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Breast Reconstruction after Mastectomy. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Breast Reconstruction after Mastectomy, including those that describe adverse events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/breast-reconstruction-mastectomy/protocol.

This is to notify the public that the EPC Program would find the following information on Breast Reconstruction after Mastectomy helpful:

A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov , a summary, including the following elements: Study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of four weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.

The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

KQ 1: For adult women who are undergoing (or have undergone) mastectomy for breast cancer, what are the comparative benefits and harms of implant-based (IBR) versus autologous (AR) breast reconstruction?

KQ 2: For adult women undergoing IBR or AR after mastectomy for breast cancer that requires either chemotherapy or radiation therapy, what is the optimal time for IBR or AR with respect to

(a) chemotherapy or

(b) radiation therapy?

KQ 3: For adult women undergoing IBR after mastectomy for breast cancer, what are the comparative benefits and harms of different types of implants ( e.g., silicone, saline)?

KQ 4: For adult women undergoing IBR after mastectomy for breast cancer, what are the comparative benefits and harms of different anatomic planes of implant placement (prepectoral, partial submuscular, and total submuscular)?

KQ 5: For adult women undergoing IBR after mastectomy for breast cancer, what are the comparative benefits and harms of IBR with versus without the use of a human acellular dermal matrix (ADM) in the reconstruction procedure?

KQ 6: For adult women undergoing AR after mastectomy for breast cancer, what are the comparative benefits and harms of different flap types for AR?

Contextual Question 1:

What patient preferences and values inform decisionmaking about breast reconstruction after mastectomy for breast cancer? This includes the initial choice to undergo reconstruction, as well as the type and timing of surgery.

Contextual Question 2:

What strategies or tools (including shared decisionmaking) are available to help women make informed choices about breast reconstruction after mastectomy for breast cancer?

The specific eligibility criteria provided below have been refined based on discussions with a panel of Key Informants (KIs) and a Technical Expert Panel (TEP).

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Adverse childhood experiences (ACEs) are preventable, potentially traumatic events that occur in childhood (0-17 years) such as experiencing violence, abuse, or neglect; witnessing violence in the home; and having a family member attempt or die by suicide. There is a robust evidence base linking ACEs to a variety of poor health outcomes across the life span, including depression, alcohol and substance use disorder, and violence perpetration and victimization. The ongoing opioid epidemic is a complex and significant public health crisis that exposes children to opioid misuse, violence, and other ACEs, and challenges the ability of Health and Human Service (HHS) systems to mitigate the effects of opioid misuse and ACEs on children and families across the U.S. American Indian/Alaska Native (AI/AN) populations experience a disproportionate burden of opioid misuse and ACEs, and ACE-related health outcomes, including opioid overdose, sexual assault, and suicide attempts. The nature and consequences of ACEs in Tribal communities is unique because of historical trauma and stark socioeconomic disparities. In addition, there are gaps in the provision of adequate healthcare.

This collection addresses critical research gaps and extends efforts to prevent violence and other ACEs before they occur and to build evidence of effectiveness of community-level strategies and approaches at the outer levels of the social ecology to Tribal communities. Results from this data collection will be communicated to relevant public health officials and community stakeholders in the study locations. These local public health officials and community stakeholders will use the study results to guide strategies to further strengthen their local prevention efforts within their regions.

Data collection methods used in this study include well-established qualitative methods, including in-depth open-ended individual interviews and focus groups. Quantitative methods include brief structured surveys. There will be a total of six Tribal communities (three urban and three rural) in regions identified with higher opioid overdose mortality rates relatively to other areas in Indian Country. Due to COVID-19, at the time of the focus groups/interviews, social distancing and public health safety measures will be implemented, including considerations for phone/virtual meetings instead of in-person sessions.

The total estimated annualized burden hours are 918. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours Type of

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Dental caries (tooth decay) is one of the most common chronic diseases among children in the United States and can lead to pain, infection, and diminished quality of life throughout the lifespan. Dental sealants are a cost-effective measure to prevent caries but remain underutilized.

To address states' critical need for state-level oral health surveillance data on dental caries and sealants, the Association of State and Territorial Dental Directors (ASTDD) developed and released an oral health screening survey protocol referred to as the Basic Screening Survey (BSS) in 1999 in collaboration with the Ohio Department of Health and with technical assistance from the CDC's Division of Oral Health.

BSS is a non-invasive visual observation of the mouth performed by trained screeners including dental and non-dental health professionals ( e.g., dentists, hygienists, school nurses). The BSS data collection is not duplicative of any other federal collection. Though the National Health and Nutrition Examination Survey (NHANES) collects national data on oral health status including dental caries and sealants based on clinical examination, it is not designed to provide state-level data. BSS is designed to be easy to perform, while being consistent and aligned with the oral health Healthy People objectives, which are based on NHANES measures. BSS is the only data source that provides state-representative data on oral health status based on clinical examination. BSS is also used to monitor state progress toward key national oral health objectives.

The BSS is a state-tailored survey administered and conducted by individual states. CDC has supported some of the 50 states to build and maintain their oral health surveillance system and ASTDD to provide technical assistance to states through state and partner cooperative agreements since 2001. Conducting BSS for third graders is a key component of that support.

The target populations include school children in grades K-3 and children enrolled in Head Start in 50 states and Washington, DC. ASTDD and CDC recommend that states conduct BSS at minimum for third graders at least once every five years. Individual states determine how often to conduct BSS and which grade or grades to target based on their program needs and available resources. Forty-seven states have conducted BSS for children, and all 47 conducted third grade BSS. Thirty-two states also have conducted BSS in one or more other grades (K-2) or in Head Start. CDC estimates that approximately 34 states, including 20 states currently funded by CDC, will conduct one BSS, at least for third grade, during the period for which this approval is being sought.

State health departments administer the survey by determining probability samples, arranging logistics with selected schools or Head Start sites, gaining consent, obtaining demographic data, training screeners, conducting the oral health screening at schools or Head Start sites. Screeners record four data points either electronically or on a paper form: (1) Presence of treated caries, (2) presence of untreated tooth decay, (3) urgency of need for treatment, and (4) presence of dental sealants on at least one permanent molar tooth.

State programs enter, clean and analyze the data; de-identify it; and respond to ASTDD's annual email request for state-aggregated prevalence of dental caries and sealants. ASTDD reviews the data to ensure that both survey design and data meet specific criteria before sending it to CDC for publication on the CDC's public-facing Oral Health Data website ( http://www.cdc.gov/oralhealthdata ).

BSS for children serves as a key state oral health surveillance data source and facilitates state capacity to (1) monitor children's oral health status, trends, and disparities, and compare with other states; (2) inform planning, implementation and evaluation of effective oral health programs and policies; (3) measure state progress toward Healthy People objectives; and (4) educate the public and policy makers regarding cross-cutting public health programs. CDC also uses the data to evaluate performance of CDC oral health funding recipients.

There are no costs to children respondents except their time. The estimated total annualized burden hours for the survey across the 34 states over the three years of this request are 40,207 with an average of 1,183 per state.

On January 17, 2013, FDA approved NDA 202278 for ZECUITY (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. On June 2, 2016, FDA issued a Drug Safety Communication announcing the FDA is investigating the risk of serious burns and potential permanent scarring with the use of ZECUITY for migraine headaches. ( https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-evaluating-risk-burns-and-scars-ZECUITY-sumatriptan-migraine-patch ). On June 10, 2016, Teva suspended sales, marketing and distribution to investigate the cause of burns and scars associated with ZECUITY.

On July 19, 2019, Teva requested withdrawal of NDA 202278 for ZECUITY under § 314.150(d) (21 CFR 314.150(d)) and waived its opportunity for a hearing. In its letter requesting withdrawal of approval, Teva stated that it voluntarily discontinued manufacture and sale of products under NDA 202278 in 2016 for commercial reasons and has agreed to withdrawal of the application for those reasons only.

For the reasons discussed above, and pursuant to the applicant's request, approval of NDA 202278 for ZECUITY (sumatriptan iontophoretic transdermal system), and all amendments and supplements thereto, is withdrawn under § 314.150(d).

Distribution of ZECUITY into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. This information collection request supports those regulations. Specifically, § 361.1 (21 CFR 361.1) sets forth specific regulations about establishing and composing radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies using radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulations and include studies of metabolism, human physiology, pathophysiology, or biochemistry.

Section 361.1(c)(2) requires that each RDRC will select a chairman, who will sign all applications, minutes, and reports of the committee. Each committee will meet at least once each quarter in which research activity has been authorized or conducted. Minutes will be kept and will include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC will submit an annual report to FDA. The annual report will include the names and qualifications of the members of and of any consultants used by the RDRC, using Form FDA 2914 entitled “Radioactive Drug Research Committee Report on Research Use of Radioactive Drugs Membership Summary.” The annual report will also include a summary of each study conducted during the preceding year, using Form FDA 2915 entitled “Radioactive Drug Research Committee Report on Research Use of Radioactive Drugs Study Summary.”

Under § 361.1(d)(5), each investigator will obtain the proper consent required under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant or, based on a pregnancy test, be confirmed as not pregnant.

Under § 361.1(d)(8), the investigator will immediately report to the RDRC all adverse effects associated with use of the drug, and the committee will then report to FDA all adverse reactions probably attributed to the use of the radioactive drug.

Section 361.1(f) sets forth labeling requirements for radioactive drugs. These requirements are not in the reporting burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)).

Types of research studies not permitted under the regulations are also specified and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes ( i.e., to carry out a clinical trial for safety or efficacy). These studies require filing of an investigational new drug application under 21 CFR part 312, and the associated information collections are covered in OMB control number 0910-0014.

The primary purpose of this collection of information is to determine whether the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson or chairpersons of each individual RDRC, investigators, and participants in the studies. The burden estimates are based on our experience with these reporting and recordkeeping requirements and the number of submissions we received under the regulations over the past 3 years.

In the Federal Register of January 21, 2020 (85 FR 3390), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

We have adjusted our estimate for the information collection to reflect an annual decrease of 525 hours and 147 responses since last OMB review. This adjustment corresponds to fewer submissions we have received under the information collection over the last few years.

Under the PRA (44 U.S.C. 3501-3521), 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.

Under the Public Health Service Act (PHS Act), the Department of Health and Human Services stockpiles medical products that are essential to the health security of the Nation (see 42 U.S.C. 247d-6b). This collection of medical products for use during national health emergencies, known as the SNS, is to provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.

It may be appropriate for certain medical products that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling regulations given their anticipated circumstances of use in an emergency. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).

Under 21 CFR 201.26, 610.68, 801.128, and 809.11 (§§ 201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center Director may grant a request for an exception or alternative to certain regulatory provisions pertaining to the labeling of human drugs, biological products, medical devices, and in vitro diagnostics that currently are or will be included in the SNS if certain criteria are met. The appropriate FDA Center Director may grant an exception or alternative to certain FDA labeling requirements if compliance with these labeling requirements could adversely affect the safety, effectiveness, or availability of products that are or will be included in the SNS. An exception or alternative granted under the regulations may include conditions or safeguards so that the labeling for such products includes appropriate information necessary for the safe and effective use of the product given the product's anticipated circumstances of use. Any grant of an exception or alternative will only apply to the specified lots, batches, or other units of medical products in the request. The appropriate FDA Center Director may also grant an exception or alternative to the labeling provisions specified in the regulations on his or her own initiative.

Under §§ 201.26(b)(1)(i) (human drug products), 610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human use) an SNS official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores such products that are or will be included in the SNS may submit, with written concurrence from a SNS official, a written request for an exception or alternative to certain labeling requirements to the appropriate FDA Center Director. Except when initiated by an FDA Center Director, a request for an exception or alternative must be in writing and must:

• Identify the specified lots, batches, or other units of the affected product;

• identify the specific labeling provisions under the regulations that are the subject of the request;

• explain why compliance with the specified labeling provisions could adversely affect the safety, effectiveness, or availability of the product subject to the request;

• describe any proposed safeguards or conditions that will be implemented so that the labeling of the product includes appropriate information necessary for the safe and effective use of the product given the anticipated circumstances of use of the product;

• provide copies of the proposed labeling of the specified lots, batches or other units of the affected product that will be subject to the exception or alternative; and

• provide any other information requested by the FDA Center Director in support of the request.

If the request is granted, the manufacturer may need to report to FDA any resulting changes to the new drug application, biologics license application, premarket approval application, or premarket notification (510(k)) in effect, if any. The submission and grant of an exception or an alternative to the labeling requirements specified in the regulations may be used to satisfy certain reporting obligations relating to changes to product applications under §§ 314.70, 601.12, 814.39, and 807.81 (21 CFR 314.70 (human drugs), 21 CFR 601.12 (biological products), 21 CFR 814.39 (medical devices subject to premarket approval), or 21 CFR 807.81 (medical devices subject to 510(k) clearance requirements)). The information collection provisions in §§ 314.70, 601.12, 807.81, and 814.39 have been approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 0910-0231 respectively. On a case-by-case basis, the appropriate FDA Center Director may also determine when an exception or alternative is granted that certain safeguards and conditions are appropriate, such as additional labeling on the SNS products, so that the labeling of such products would include information needed for safe and effective use under the anticipated circumstances of use.

Respondents to this collection of information are entities that manufacture (including labeling, packing, relabeling, or repackaging), distribute or store affected SNS products. Based on data from fiscal years 2017, 2018, and 2019, FDA estimates an average of one request annually for an exception or alternative received by FDA. FDA estimates an average of 24 hours preparing each request. The average burden per response for each submission is based on the estimated time that it takes to prepare a supplement to an application, which may be considered similar to a request for an exception or alternative. To the extent that labeling changes not already required by FDA regulations are made in connection with an exception or alternative granted under the regulations, FDA is estimating one occurrence annually in the event FDA would require any additional labeling changes not already covered by FDA regulations. FDA estimates 8 hours to develop and revise the labeling to make such changes. The average burden per response for each submission is based on the estimated time to develop and revise the labeling to make such changes.

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

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports FDA's animal drug and animal generic drug user fee programs. The Animal Drug User Fee Act of 2003 (ADUFA) (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-12), which requires that FDA assess and collect user fees with respect to new animal drug applications for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from, or a reduction of, those fees in certain circumstances. The Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316) added section 741 of the FD&C Act (21 U.S.C. 379j-21), which establishes three different kinds of user fees: (1) Fees for certain types of abbreviated applications for generic new animal drugs; (2) annual fees for certain generic new animal drug products; and (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (21 U.S.C. 379j-21(a)). On August 14, 2018, H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, was signed into law to reauthorize the ADUFA and AGDUFA programs administered by FDA.

Sponsors of new animal drug applications prepare and submit user fee cover sheets. The Animal Drug User Fee cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether an application fee waiver was granted, to determine the amount of the fee required, and to ensure that each animal drug user fee payment is appropriately linked to the animal drug application for which payment is made. The form, when completed electronically, results in the generation of a unique payment identification number used by FDA to track the payment. The information collected is used by FDA's Center for Veterinary Medicine (CVM) to initiate the administrative screening of new animal drug applications and supplements. The information collection associated with the Animal Drug User Fee cover sheet currently is approved under OMB control number 0910-0539.

Sponsors of abbreviated new animal drug applications also prepare and submit user fee cover sheets. The Animal Generic Drug User Fee cover sheet (Form FDA 3728) similarly is designed to collect the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to ensure that each animal generic drug user fee payment is appropriately linked to the abbreviated new animal drug application for which payment is made. The form, when completed electronically, results in the generation of a unique payment identification number used by FDA to track the payment. The information collected is used by CVM to initiate the administrative screening of abbreviated new animal drug applications. The information collection associated with the Animal Generic Drug User Fee cover sheet currently is approved under OMB control number 0910-0632.

FDA has also developed a guidance for industry (GFI) #170 entitled “Animal Drug User Fees and Fee Waivers and Reductions.” This guidance provides guidance on the types of fees FDA is authorized to collect under section 740 of the FD&C Act, and how to request waivers and reductions from these fees. Further, this guidance also describes what information FDA recommends be submitted in support of a request for a fee waiver or reduction; how to submit such a request; and FDA's process for reviewing requests. FDA uses the information submitted by respondents to determine whether to grant the requested fee waiver or reduction. The information collection associated with GFI #170 currently is approved under OMB control number 0910-0540.

The information collection provisions approved under OMB control numbers 0910-0539, 0910-0540, and 0910-0632 are similar in that they support FDA's animal drug and animal generic drug user fee programs. Thus, with this notice, FDA proposes to consolidate these collections of information into one OMB control number for government efficiency and to allow the public to look to one OMB control number for all reporting associated with FDA's animal drug and animal generic drug user fee programs. Because we are proposing to combine all reporting associated with FDA's animal drug user fees into one collection, we are consolidating the burden under OMB control number 0910-0540 and discontinuing OMB control numbers 0910-0539 and 0910-0632.

Description of Respondents: Respondents to this collection of information are new animal drug applicants and abbreviated new animal drug applicants. In addition, requests for waivers or reductions of user fees may be submitted by a person responsible for paying or potentially responsible for paying any of the animal drug user fees assessed, including application fees, product fees, establishment fees, or sponsor fees.

In the Federal Register of January 23, 2020 (85 FR 3929), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

For the purpose of this consolidation, we rely on our previous estimates of the number of user fee cover sheet and waiver and other request submissions. We estimate 21 respondents will each submit 1 Animal Drug User Fee cover sheet (Form FDA 3546) for a total of 21 responses. We estimate 20 respondents will each submit 2 Animal Generic Drug User Fee cover sheets (Form FDA 3728) for a total of 40 responses. Our estimate of the number of waiver and other request submissions is detailed in table 1. These estimates are consistent with our previous estimates except for the row labeled, Request for review (user fee appeal officer), for which we have increased the estimated number of respondents from zero to one and the average burden per response from 0 to 2 hours to correct the error in our previous submission. We base our estimates of the average burden per response on our experience with the submission of similar cover sheets and waiver and other requests.

The information collection reflects an increase in burden by an additional 26 hours and 62 responses due to the consolidation of the information collections covered by OMB control numbers 0910-0539, “Animal Drug User Fee Cover Sheet,” and 0910-0632, “Animal Generic Drug User Fee Cover Sheet” and the correction of the error in our previous submission.