Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal, 49537-49538 [2021-19108]
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
William Parham at (410) 786–4669.
[Document Identifier: CMS–10637]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by October 4, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain . Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
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Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Marketplace
Operations; Use: The data collections
and third-party disclosure requirements
will assist HHS in determining
Exchange compliance with Federal
standards and monitoring QHP issuers
in FFEs for compliance with Federal
QHP issuer standards. The data
collection will also assist HHS in
monitoring Web-brokers for compliance
with Federal Web-broker standards. The
data collected by health insurance
issuers and Exchanges will help to
inform HHS, Exchanges, and health
insurance issuers as to the participation
of individuals, employers, and
employees in the individual Exchange,
the SHOP, and the premium
stabilization programs. Form Number:
CMS–10637 (OMB control number
0938–1353); Frequency: Annually;
Affected Public: Private sector (Business
or other for-profits); Number of
Respondents: 3,902; Total Annual
Responses: 3,902; Total Annual Hours:
2,336,190. (For policy questions
regarding this collection contact:
Nikolas Berkobien at 301–492–4400.)
Dated: August 31, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–19142 Filed 9–2–21; 8:45 am]
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49537
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3402]
Advisory Committee; National
Mammography Quality Assurance
Advisory Committee; Renewal
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; renewal of advisory
committee.
AGENCY:
The Food and Drug
Administration (FDA) is announcing the
renewal of the National Mammography
Quality Assurance Advisory Committee
by the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the National
Mammography Quality Assurance
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until July 7, 2023, expiration date.
DATES: Authority for the National
Mammography Quality Assurance
Advisory Committee will expire on July
7, 2023, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Office of Management,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5214, Silver Spring, MD 20993–
0002, 301–796–0400, email:
aden.asefa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
National Mammography Quality
Assurance Advisory Committee (the
Committee). The committee is a nondiscretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Commissioner is charged with
the administration of the Federal Food,
Drug and Cosmetic Act and various
provisions of the Public Health Service
Act. The Mammography Quality
Standards Act of 1992 amends the
Public Health Service Act to establish
national uniform quality and safety
standards for mammography facilities.
The National Mammography Quality
Assurance Advisory Committee advises
the Secretary and, by delegation, the
Commissioner or designee in
discharging their responsibilities with
SUMMARY:
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49538
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/
VerDate Sep<11>2014
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Jkt 253001
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. 2021–19108 Filed 9–2–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
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 else’s 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 (HFA–305), 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–
2014–D–0609 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
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]]>Agencies
[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49537-49538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3402]
Advisory Committee; National Mammography Quality Assurance
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the National Mammography Quality Assurance Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the National Mammography Quality Assurance Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until July 7, 2023, expiration date.
DATES: Authority for the National Mammography Quality Assurance
Advisory Committee will expire on July 7, 2023, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Aden Asefa, Office of Management,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver
Spring, MD 20993-0002, 301-796-0400, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the National Mammography Quality Assurance Advisory
Committee (the Committee). The committee is a non-discretionary Federal
advisory committee established to provide advice to the Commissioner.
The Commissioner is charged with the administration of the Federal
Food, Drug and Cosmetic Act and various provisions of the Public Health
Service Act. The Mammography Quality Standards Act of 1992 amends the
Public Health Service Act to establish national uniform quality and
safety standards for mammography facilities. The National Mammography
Quality Assurance Advisory Committee advises the Secretary and, by
delegation, the Commissioner or designee in discharging their
responsibilities with
[[Page 49538]]
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/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/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. 2021-19108 Filed 9-2-21; 8:45 am]
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