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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices
Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https www.regulations.gov at Docket Nos. FDA2013S0610. Submit written petitions two copies are required to the Dockets Management Staff HFA305, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD.
Dated: October 22, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202123725 Filed 102921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N1026

Agency Information Collection Activities; Proposed Collection;
Comment Request; Text Analysis of Proprietary Drug Name Interpretations 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled Text Analysis of Proprietary Drug Name Interpretations.
DATES: Submit either electronic or written comments on the collection of information by January 3, 2022.
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 January 3, 2022. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 3, 2022. 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.

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SUMMARY:

Electronic Submissions Submit electronic comments in the following way:

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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.
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
2021N1026 for Agency Information Collection Activities; Proposed Collection; Comment Request; Text Analysis of Proprietary Drug Name Interpretations. 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

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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 FDAs 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-201509-18/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, 2404027500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, Ila.Mizrachi@
fda.hhs.gov.
For copies of the questionnaire: Office of Prescription Drug Promotion OPDP
Research Team, DTCResearch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA 44 U.S.C. 35013521, 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. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB
for approval. To comply with this requirement, FDA is publishing notice
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