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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter nonprescription human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advises the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee serves as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency sponsored intramural and extramural scientific biomedical programs in support of FDAs mission and regulatory responsibilities.
The Committee shall consist of 10
voting members including the Chair.
Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. Federal members will serve as Regular Government Employees or Ex-Officios.
The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumeroriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.
Further information regarding the most recent charter and other information can be found at https
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
nonprescription-drugs-advisorycommittee or by contacting the Designated Federal Officer see FOR
FURTHER INFORMATION CONTACT. In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

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This notice is issued under the Federal Advisory Committee Act 5
U.S.C. app.. For general information related to FDA advisory committees, please visit us at https www.fda.gov/
advisory-committees.
Dated: August 20, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118396 Filed 82521; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020N2319

Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments;
Extension of Comment Period AGENCY:

Food and Drug Administration,
HHS.
Notice; request for comments;
extension of comment period.

ACTION:

The Food and Drug Administration FDA or Agency is extending the comment period for the request for comments that appeared in the Federal Register of June 15, 2021. In that notice, FDA requested comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications NDAs, abbreviated new animal drug applications ANDAs, or applications for conditional approval.
The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the request for comments published on June 15, 2021 86 FR
31720. Submit either electronic or written comments by November 12, 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 November 12, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 12, 2021.
Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely SUMMARY:

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if they are postmarked or the delivery service acceptance receipt is on or before that date.
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 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
2020N2319 for Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine. 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
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