Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices Antibody Cocktails for the Passive Immunization Component of PostExposure Prophylaxis. It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information associated with submissions of content and format of labeling for drugs and biologics in 21
CFR 201.56 and 201.57 have been approved under OMB control number 09100572; the collections of information associated with submissions of investigational new drug applications in 21 CFR part 312 have been approved under OMB control numbers 09100014; the collections of information associated with submissions of applications for approval to market a new drug in 21 CFR part 314
have been approved under 09100001;
the collections of information associated with the reporting and recordkeeping of postmarketing adverse drug experiences have been approved under OMB control numbers 09100001, 09100230, 0910
0291, and 09100645; and the collections of information associated with general licensing provisions for biologics in 21 CFR part 601 have been approved under OMB control number 09100338.
III. Electronic Access
jbell on DSKJLSW7X2PROD with NOTICES

Persons with access to the internet may obtain the draft guidance at https
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https
www.regulations.gov.
Dated: July 26, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116175 Filed 72821; 8:45 am BILLING CODE 416401P

VerDate Sep<11>2014

19:19 Jul 28, 2021

Jkt 253001

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0584

Agency Information Collection Activities; Proposed Collection;
Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.
Under the Paperwork Reduction Act of 1995 PRA, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with a pilot survey to develop standardized reporting forms for capturing performance data for federally funded public health projects.
DATES: Submit either electronic or written comments on the collection of information by September 27, 2021.
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 27, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 27, 2021.
Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
SUMMARY:

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
PO 00000

Frm 00052

Fmt 4703

Sfmt 4703

40853

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.
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.
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
2021N0584 for Pilot Survey to Develop Standardized Reporting Forms for Federally Funded Public Health Projects administered by the Office of Regulatory Affairs ORA. Received comments, those filed in a timely manner see ADDRESSES, 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
E:FRFM29JYN1.SGM

29JYN1