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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
for-profit institutions; Number of Respondents: 20,000; Total Annual Responses: 4,589,433; Total Annual Hours: 351,046. For policy questions regarding this collection contact Michael Forman at 4107862666.
2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Administrative Requirements for Section 6071 of the Deficit Reduction Act; Use: State Operational Protocols should provide enough information such that: the CMS
Project Officer and other federal officials may use it to understand the operation of the demonstration, prepare for potential site visits without needing additional information, or both; the State Project Director can use it as the manual for program implementation;
and external stakeholders may use it to understand the operation of the demonstration. The financial information collection is used in our financial statements and shared with the auditors who validate CMS financial position. The Money Follows the Person Rebalancing Demonstration MFP
Finders File, MFP Program Participation Data file, and MFP Services File are used by the national evaluation contractor to assess program outcomes while we use the information to monitor program implementation. The MFP
Quality of Life data is used by the national evaluation contractor to assess program outcomes. The evaluation is used to determine how participants quality of life changes after transitioning to the community. The semi-annual progress report is used by the national evaluation contractor and CMS to monitor program implementation at the grantee level. The revisions aim to reduce the reporting burden by presenting a substantially revised and shorted version of the semi-annual progress report. The budget workbook has also been revised to combine two earlier reporting forms. Form Number:
CMS10249 OMB control number:
09381053; Frequency: Yearly, quarterly, and semi-annually; Affected Public: State, Local, or Tribal Governments; Number of Respondents:
42; Total Annual Responses: 336; Total Annual Hours: 2,604. For policy questions regarding this collection contact Todd Wilson at 4107863409.
3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Section 1115
Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428; Use: This collection is necessary to ensure that states comply with regulatory and
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statutory requirements related to the development, implementation and evaluation of demonstration projects.
States seeking waiver authority under Section 1115 are required to meet certain requirements for public notice, the evaluation of demonstration projects, and reports to the Secretary on the implementation of approved demonstrations. Form Number: CMS
10341 OMB control number: 0938
1162; Frequency: Yearly and quarterly;
Affected Public: State, Local, or Tribal Governments; Number of Respondents:
37; Total Annual Responses: 372; Total Annual Hours: 27,914. For policy questions regarding this collection contact Tonya Moore at 4107860019.
Dated: July 6, 2021.
William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
FR Doc. 202114671 Filed 7821; 8:45 am BILLING CODE 412001P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2014N2347

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Food and Cosmetic Export Certificates Food and Drug Administration, Health and Human Services HHS.
ACTION: Notice.
AGENCY:

The Food and Drug Administration FDA or we is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Submit written comments including recommendations on the collection of information by August 9, 2021.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting Currently under ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100793. Also include the FDA docket number found in brackets in the heading of this document.
SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.
Food and Cosmetic Export Certificates OMB Control Number 09100793
Extension Some countries may require manufacturers of FDA-regulated products to provide certificates for products they wish to export to that country. Accordingly, firms exporting products from the United States often ask FDA to provide such a certificate.
In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States, or that they meet specific U.S. requirements. In some cases, review of an FDA export certificate may be required as part of the process to register or import a product into another country. An export certificate generally indicates that the particular product is marketed in the United States or otherwise eligible for export and that the particular manufacturer has no unresolved enforcement actions pending before, or taken by, FDA.
FDAs Center for Food Safety and Applied Nutrition CFSAN issues export certificates for human food and cosmetic products. Interested persons may request a certificate electronically via the CFSAN Export Certification Application and Tracking System CFSAN eCATS or Certificate Application Process CAP, components of the FDA Industry Systems, or by contacting CFSAN for assistance. Health certificates are the exception and are requested via email. To facilitate the application process, we have eliminated paper-based forms. For food products, respondents are able to identify facilities using their Food Facility Registration, an FDA Establishment Identifier number, or a Data Universal Numbering System number. The system uses these identifiers to locate and autopopulate name and address information, eliminating the need for users to manually enter this information and reducing the time to complete the application. For some applications, respondents can also upload product information via a spreadsheet, which reduces the time needed to enter
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