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Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices these data for use in estimating future costs of the refugee resettlement program. ORR must implement the methodology at CFR 400.211 each year after receipt of its annual appropriation to ensure that appropriated funds will be adequate for reimbursement to States of the costs for assistance provided to entering refugees. The estimating
methodology prescribed in the regulations requires the use of actual past costs by program component. If the methodology indicates that appropriated funds are inadequate, ORR
must take steps to reduce federal expenses, such as by limiting the number of months of eligibility for Refugee Cash Assistance and Refugee
41853

Medical Assistance. This single-page financial report allows ORR to collect the necessary data to ensure that funds are adequate for the projected need and thereby meet the requirements of both the Refugee Act and ORR regulations.
Respondents: State governments and Replacement Designees.

ANNUAL BURDEN ESTIMATES
Instrument
Total number of respondents
Annual number of responses per respondent
Average burden hours per response
Annual burden hours
ORR Financial Status Report Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations

63

4

1.50

378

Estimated Total Annual Burden Hours: 378.
Authority: 8 U.S.C. 1522 of the Immigration and Nationality Act the Act Title IV, Sec. 412 of the Act for each state agency requesting federal funding for refugee resettlement under 8
U.S.C. 524 Title IV, Sec. 414 of the Act.

written comments by September 2, 2021
to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:

Mary B. Jones, ACF/OPRE Certifying Officer.

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 elses 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 written/paper submission and in the manner detailed see Written/Paper Submissions and Instructions.

FR Doc. 202116470 Filed 8221; 8:45 am BILLING CODE 418445P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020D2024

Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability;
Extension of Comment Period AGENCY:

Food and Drug Administration,
HHS.
Notice of availability; extension of comment period.

ACTION:

The Food and Drug Administration FDA or the Agency is extending the comment period for the notice of availability entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability that appeared in the Federal Register of June 4, 2021.
The Agency is taking this action to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period for the notice of availability published on June 4, 2021 86 FR
30053. Submit either electronic or
jbell on DSKJLSW7X2PROD with NOTICES

SUMMARY:

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Electronic Submissions
Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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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
2020D2024 for Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry. 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, 2404027500.
Confidential SubmissionsTo 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
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