Federal Register - August 10, 2021
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Fuente: Federal Register
43666
Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices
20852, 3017967726, PRAStaff@
fda.hhs.gov.
The following is a list of FDA information collections recently approved by OMB
under section 3507 of the Paperwork
SUPPLEMENTARY INFORMATION:
Reduction Act of 1995 44 U.S.C. 3507.
The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet
at https www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
TABLE 1LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control number
Title of collection Infant Formula Requirements
Shortages Data Collection
Guidance on Labeling for Natural Rubber Latex Condoms
Section 513g Requests for Information
Dated: August 5, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202117045 Filed 8921; 8:45 am BILLING CODE 416401P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020N1648
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a public docket; request for comments.
ACTION:
The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
DATES: The meeting will be held on September 17, 2021, from 10 a.m. to 4:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the COVID19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
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SUMMARY:
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FDA is establishing a docket for public comment on this meeting. The docket number is FDA2020N1648.
The docket will close on September 16, 2021. Submit either electronic or written comments on this public meeting by September 16, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 16, 2021. The https
www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 16, 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.
Comments received on or before September 3, 2021, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
You may submit comments 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
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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
2020N1648 for Pediatric Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments. 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
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