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Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1Continued Activity/21 CFR Section
Total
1 There
Dated: August 31, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119218 Filed 9321; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0965

sradovich on DSKJLST7X2PROD with NOTICES

Number of responses per respondent

Total annual responses 432,929

Average burden per response

Total hours 1,881,839

are no capital costs or operating and maintenance costs associated with this collection of information.

New drug product and biological product applicants must: 1 Design and create prescription drug labeling containing Highlights, Contents, and Full Prescribing Information; 2
test the designed labeling for example, to ensure that the designed labeling fits into carton-enclosed products; and 3
submit it to FDA for approval. Based on our experience with the information collection, we estimate 414 applicants will prepare an average of 549
prescription drug labels and assume it will require 3,349 hours to design, test, and submit to FDA as part of a new drug application or a biologics license application. Similarly, new medical gas containers must meet applicable requirements found in part 211, as well as specific labeling requirements in 201.328. We estimate that 260
respondents will incur burden for the design, testing, production, and submission of labeling for new medical gas containers as required under 201.328 and assume an average of 10
minutes 0.17 is required for these activities.
Our estimated burden for the information collection reflects an overall increase resulting from an increase in submissions for new product labeling as well as from the revision to include burden associated with requirements in 201.328.

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

Number of respondents
Food and Drug Administration,
HHS.
Notice; establishment of a public docket; request for comments.

ACTION:

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The Food and Drug Administration FDA or Agency announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues.
The meeting will be open to the public.
FDA is establishing a docket for public comment on this document.
Consistent with FDAs regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent submission of a request to supplement the approved Biologics License Application for COMIRNATY
for administration of a third dose, or booster dose, of the COVID19
vaccine, in individuals 16 years of age and older and the need for prompt discussion of such submission given the COVID19 pandemic.
DATES: The meeting will be held on September 17, 2021, from 8:30 a.m. to 3:45 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The online web conference meeting will be available at the following link on the day of the meeting: https youtu.be/
WFph7-6t34M.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA2021N0965.
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 SUMMARY:

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written/paper submissions will be considered timely if they are received on or before that date.
Comments received on or before September 13, 2021, will be provided to the committee. Comments received after September 13, 2021, and by September 16, 2021, will be taken into consideration by FDA. In the event that the meeting is canceled, FDA will continue to evaluate any relevant applications, submissions, 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 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
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