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 

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 

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, 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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices 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-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 

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

Type of respondent Form No. 2 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

(in hours) 

Total 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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2All 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 

AGENCY: Food and Drug Administration 

(FDA), Department of Health and 

Human Services (HHS). 

ACTION: Notice; withdrawal. 

SUMMARY: 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 

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 


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