Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 36559 

Administration for Community Living, 

Washington, DC 20201, Attention: 

Susan Jenkins. 

FOR FURTHER INFORMATION CONTACT: 

Susan Jenkins, Administration for 

Community Living, Washington, DC 

20201, 202–795–7369 or by email: 

Susan.Jenkins@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

The PRA 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, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, ACL invites 

comments on our burden estimates or 

any other aspect of this collection of 

information, including: 

(1) Whether the proposed collection 

of information is necessary for the 

proper performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; (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. 

The Evidence Based Program Fidelity 

Surveys will be used by ACL to evaluate 

the fidelity with which ACL’s grantee 

organizations, under the Older 

Americans Act, implement the required 

evidence-based programs. States that 

receive Older Americans Act funds 

under Title III–D are required to spend 

those funds on evidence-based programs 

to improve the health and well-being of 

their clients and to reduce disease and 

injury. Since 2003, the aging services 

network has been steadily moving 

towards wider implementation of 

disease prevention and health 

promotion programs that are based on 

scientific evidence and demonstrated to 

improve the health of older adults. The 

FY 2012 Congressional appropriations 

law included, for the first time, an 

evidence-based requirement related to 

Title III–D funds. 

The results of this information 

collection will be used by ACL/AoA to: 

• Effectively report its results to the 

President, to Congress, to the 

Department of Health and Human 

Services and to the public. 

• Assess the effectiveness of ACL and 

its grantees in monitoring program 

fidelity. 

• Aid in program refinement and 

continuous improvement. 

To comment on this information 

collection please visit the ACL website: 

https://www.acl.gov/about-acl/publicinput. 

Estimated Program Burden 

ACL estimates the burden associated 

with this collection of information as 

follows: 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual burden 

hours 

Grantee: Program selection process and survey ............................................ 103 1 2.00 206 

Local Implementation Organization Survey ..................................................... 412 1 0.67 275 

Total .......................................................................................................... 515 1 0.93 481 

Dated: July 6, 2021. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2021–14700 Filed 7–9–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–1997] 

Food and Drug Administration 

Oversight of Food Products Covered 

by Systems Recognition 

Arrangements; Draft Guidance for 

Food and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for FDA staff entitled ‘‘FDA 

Oversight of Food Products Covered by 

Systems Recognition Arrangements.’’ 

This draft guidance provides 

recommendations related to the FDA’s 

regulatory oversight activities for food 

products imported from countries 

whose food safety systems the FDA has 

recognized in Systems Recognition 

Arrangements (SRAs). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 10, 2021 to ensure that 

the Agency considers your comment on 

the draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 


khammond on DSKJM1Z7X2PROD with NOTICES
36560 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–1997 for ‘‘FDA Oversight of 

Food Products Covered by Systems 

Recognition Arrangements; Draft 

Guidance for FDA Staff.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for a single 

hard copy of the draft guidance entitled 

‘‘FDA Oversight of Food Products 

Covered by Systems Recognition 

Arrangements’’ to the Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Building, Rm. 4148, Rockville, 

MD 20857. Send one self-addressed 

adhesive label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Marla Hallacy, Office of Regulatory 

Affairs, Division of Operational Policy, 

Food and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20857, 

240–402–6674. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for FDA staff entitled 

‘‘FDA Oversight of Food Products 

Covered by Systems Recognition 

Arrangements; Draft Guidance for FDA 

Staff.’’ The draft guidance is part of 

FDA’s larger effort to take a risk-based 

approach to food safety to include 

ensuring the safety of imported food, 

consistent with the FDA Food Safety 

Modernization Act. The guidance covers 

FDA’s regulatory oversight activities for 

food products covered by SRAs between 

FDA and its foreign regulatory 

counterparts. Currently, the FDA has 

signed SRAs with food safety agencies 

in Australia, Canada, and New Zealand. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the topic of Systems Recognition 

Arrangement implementation. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternate approach if it 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://

www.regulations.gov. 

Dated: July 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14789 Filed 7–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–5364] 

Submission of Plans for Cigarette 

Packages and Cigarette 

Advertisements (Revised); Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

final guidance for industry entitled 

‘‘Submission of Plans for Cigarette 

Packages and Cigarette Advertisements 

(Revised).’’ This is a revision to the 

third edition of this final guidance, 

which issued in February 2021, and is 

intended to assist those required to 

submit cigarette plans for cigarette 

packages and cigarette advertisements 

by providing content, timing, and other 

recommendations related to those 

submissions. FDA is revising this 

guidance to reflect the May 21, 2021, 

court order that postponed the effective 

date of the final rule entitled ‘‘Tobacco 

Products; Required Warnings for 

Cigarette Packages and Advertisements’’ 

to July 13, 2022. Pursuant to the court 

order, this revised guidance strongly 

encourages entities to submit cigarette 

plans to FDA as soon as possible after 

publication of the final rule, and in any 

event, by the recommended submission 

date, which is currently September 13, 

2021. 


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