Federal Register - September 3, 2021

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Source: Federal Register

lotter on DSK11XQN23PROD with NOTICES1

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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
respect to establishing a mammography facilities certification program. The Committee shall advise the HHS
Secretary and the Commissioner or designee on:
A Developing appropriate quality standards and regulations for mammography facilities;
B Developing appropriate standards and regulations for bodies accrediting mammography facilities under this program;
C Developing regulations with respect to sanctions;
D Developing procedures for monitoring compliance with standards;
E Establishing a mechanism to investigate consumer complaints;
F Reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities;
G Determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas;
H Determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and I Determining the costs and benefits of compliance with these requirements.
The Committee shall consist of a core of 15 members, including the Chair.
Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Members will be invited to serve for overlapping terms of up to 4 years. Almost all members of this committee serve as Special Government Employees. The core of voting members shall include at least four individuals from among national breast cancer or consumer health organizations with expertise in mammography, and at least two practicing physicians who provide mammography services. In addition to the voting members, the Committee shall include two nonvoting industry representative members who have expertise in mammography equipment.
The Committee may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests.
Further information regarding the most recent charter and other information can be found at https
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/RadiationEmittingProducts/
NationalMammography QualityAssuranceAdvisoryCommittee/

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ucm520365.htm 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.
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/
AdvisoryCommittees/default.htm.
Dated: August 31, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119108 Filed 9221; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2014D0609

Agency Information Collection Activities; Proposed Collection;
Comment Request; Drug Supply Chain Security Act Implementation AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or Agency 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 the Federal Food, Drug, and Cosmetic Act FD&C
Act.
DATES: Submit either electronic or written comments on the collection of information by November 2, 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 2, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 2, 2021.
Comments received by mail/hand delivery/courier for written/paper SUMMARY:

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submissions will be considered timely 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
2014D0609 for Agency Information Collection Activities; Proposed Collection; Comment Request; Drug Supply Chain Security Act Implementation. 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
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Federal Register - September 3, 2021

TitoloFederal Register

PaeseStati Uniti

Data03/09/2021

Conteggio pagine449

Numero di edizioni7801

Prima edizione14/03/1936

Ultima edizione24/06/2026

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