Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificates, 36282-36283 [2021-14650]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 36282 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 410–786–2666.) 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: CMS–10249 (OMB control number: 0938–1053); 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 410–786–3409.) 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 VerDate Sep<11>2014 17:01 Jul 08, 2021 Jkt 253001 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 410–786–0019.) Dated: July 6, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–14671 Filed 7–8–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2347] 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 Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0793. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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 0910–0793— 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. FDA’s 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 E:\FR\FM\09JYN1.SGM 09JYN1 Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices product information, particularly for applications that include multiple products. All information is entered using electronic Forms FDA 3613d, 3613e, and 3613k and used to evaluate certificate requests. The eCATS Module is Form FDA 3613k, where Form FDA 3613e is the Certificate of Free Sale (https://www.fda.gov/food/food-exportcertificates/online-applications-exportcertificates-food). All ‘‘forms’’ are electronic and part of the eCATS or CAP portal accessed via https:// www.access.fda.gov. To view representations of the forms, you have to download the instructions, which are accessible from the following links: https://www.fda.gov/cosmetics/ cosmetics-exporters/onlineapplications-export-certificatescosmetics and https://www.fda.gov/ food/food-export-certificates/onlineapplications-export-certificates-food. While burden associated with information collection activities for export certificates issued for other FDAregulated products is approved under OMB control number 0910–0498, this collection specifically supports export certificates issued by CFSAN. Also, because we have eliminated paperbased forms, respondents who require assistance with completing export certificate applications online may contact CFSAN directly by email (CFSANExportCertification@ fda.hhs.gov) or telephone (240–402– 2307). Instructions for requesting export certificates for cosmetics (Form FDA 3613d) are available online at https:// www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-cosmetics and instructions for requesting export certificates for food (Forms FDA 3613e and 3613k) are available online at https://www.fda.gov/ food/food-export-certificates/onlineapplications-export-certificates-food. Description of Respondents: The respondents to this collection of information are firms interested in 36283 exporting U.S.-manufactured human food and cosmetic products to foreign countries that require export certificates. In the Federal Register of March 16, 2021 (86 FR 14452), we published a 60day notice requesting public comment on the proposed collection of information. We received one comment offering general support for our cosmetic export certificate program. The comment also recommended FDA consider providing certificates that allow exporters to use an exemption from requirements in China for animal testing for certain imported cosmetic products. We appreciate the comment and continue to seek ways to increase the utility of the information collection as our limited resources permit. At the same time, the comment did not suggest we revise the burden we attribute to the associated information collection activity. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent Total annual responses Average burden per response (in hours) Type of respondent Form No. 2 Cosmetics ..................... Food ............................. FDA 3613d .................. FDA 3613e, 3613k ...... 113 468 3 9 339 4,212 0.5 (30 minutes) .......... 0.5 (30 minutes) .......... 170 2,106 Total ...................... ..................................... ........................ ........................ ........................ ..................................... 2,276 Total hours 1 There 2 All are no capital costs or operating and maintenance costs associated with this collection of information. forms are submitted electronically via FDA Industry Systems. Based on a review of the information collection since our last OMB approval, we have reduced our burden estimate. The burden estimate has been lowered due to a reduced number of respondents. We base our estimates on our experience with certificate applications received in the past 3 fiscal years. Dated: July 2, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14650 Filed 7–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–Z–0025] Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation; Withdrawal Food and Drug Administration (FDA), Department of Health and Human Services (HHS). ACTION: Notice; withdrawal. AGENCY: The Department of Health and Human Services (Department or HHS) is announcing the withdrawal of a notice published in the Federal Register on January 21, 2021, entitled ‘‘Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.’’ HHS also withdraws the requests for proposals issued on its website on September 24, 2020, and revised on January 13, 2021, and ends the period for submission of proposals jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:01 Jul 08, 2021 Jkt 253001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 in response to the requests for proposals. DATES: The notice published in the Federal Register on January 21, 2021, at 86 FR 6343, is withdrawn as of July 9, 2021. FOR FURTHER INFORMATION CONTACT: Katelyn Mineo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993, 301–796– 1054. SUPPLEMENTARY INFORMATION: On September 24, 2020, HHS issued two requests for proposals for the reimportation of insulin and the personal importation of prescription drugs (collectively, the RFPs) and posted related ‘‘Frequently Asked Questions’’ documents (FAQs) on its website. On January 21, 2021, HHS published a notice in the Federal Register entitled ‘‘Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation’’ (the HHS Notice) (86 FR 6343). The HHS Notice referred to revised versions E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36282-36283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2347]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Cosmetic 
Export Certificates

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0793. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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 0910-0793--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.
    FDA's 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 auto-populate 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

[[Page 36283]]

product information, particularly for applications that include 
multiple products.
    All information is entered using electronic Forms FDA 3613d, 3613e, 
and 3613k and used to evaluate certificate requests. The eCATS Module 
is Form FDA 3613k, where Form FDA 3613e is the Certificate of Free Sale 
(https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food). All ``forms'' are electronic and part of the 
eCATS or CAP portal accessed via https://www.access.fda.gov. To view 
representations of the forms, you have to download the instructions, 
which are accessible from the following links: https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
    While burden associated with information collection activities for 
export certificates issued for other FDA-regulated products is approved 
under OMB control number 0910-0498, this collection specifically 
supports export certificates issued by CFSAN. Also, because we have 
eliminated paper-based forms, respondents who require assistance with 
completing export certificate applications online may contact CFSAN 
directly by email ([email protected]) or telephone 
(240-402-2307). Instructions for requesting export certificates for 
cosmetics (Form FDA 3613d) are available online at https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and instructions for requesting export certificates for food 
(Forms FDA 3613e and 3613k) are available online at https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
    Description of Respondents: The respondents to this collection of 
information are firms interested in exporting U.S.-manufactured human 
food and cosmetic products to foreign countries that require export 
certificates.
    In the Federal Register of March 16, 2021 (86 FR 14452), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment offering general 
support for our cosmetic export certificate program. The comment also 
recommended FDA consider providing certificates that allow exporters to 
use an exemption from requirements in China for animal testing for 
certain imported cosmetic products. We appreciate the comment and 
continue to seek ways to increase the utility of the information 
collection as our limited resources permit. At the same time, the 
comment did not suggest we revise the burden we attribute to the 
associated information collection activity.
    We estimate the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Number of
          Type of respondent                 Form No. \2\           Number of     responses per   Total annual      Average burden per      Total hours
                                                                   respondents     respondent       responses      response (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics............................  FDA 3613d...............             113               3             339  0.5 (30 minutes).......             170
Food.................................  FDA 3613e, 3613k........             468               9           4,212  0.5 (30 minutes).......           2,106
                                                                ----------------------------------------------------------------------------------------
    Total............................  ........................  ..............  ..............  ..............  .......................           2,276
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via FDA Industry Systems.

    Based on a review of the information collection since our last OMB 
approval, we have reduced our burden estimate. The burden estimate has 
been lowered due to a reduced number of respondents. We base our 
estimates on our experience with certificate applications received in 
the past 3 fiscal years.

    Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14650 Filed 7-8-21; 8:45 am]
BILLING CODE 4164-01-P