National Mammography Quality Assurance Advisory Committee, Renewal, 48867-48868 [2015-20050]
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48867
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Registration Screens .......................................................................................
299
1
0.15
44.85
Estimated Total Annual Burden
Hours: 45.
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[FR Doc. 2015–20121 Filed 8–13–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
National Mammography Quality
Assurance Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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18:50 Aug 13, 2015
Jkt 235001
years beyond the charter expiration
date. The new charter will be in effect
until July 6, 2017.
DATES: Authority for the National
Mammography Quality Assurance
Advisory Committee will expire on July
6, 2017 unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT: Sara
J. Anderson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg 66, Rm. 1643, Silver Spring,
MD, 20993,
Sara.Anderson@fda.hhs.gov, 301 796–
7047.
SUPPLEMENTARY INFORMATION: Under 41
CFR 102–3.65 and approval by the
Department of Health and Human
Services under 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 is a statutory Federal
advisory committee established to
provide advice to the Commissioner.
The Secretary and, by delegation, the
Assistant Secretary for the Office of
Public Health and Science, and the
Commissioner of Food and Drugs are
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 of Food and Drugs in
discharging their responsibilities with
respect to establishing a mammography
facilities certification program.
The Committee shall advise the Food
and Drug Administration 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;
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Frm 00064
Fmt 4703
Sfmt 4703
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
four years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members shall include at
least 4 individuals from among national
breast cancer or consumer health
organizations with expertise in
mammography, and at least 2 practicing
physicians who provide mammography
services. In addition to the voting
members, the Committee shall include 2
nonvoting industry representatives 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/National
MammographyQualityAssurance
AdvisoryCommittee/ucm124611.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
E:\FR\FM\14AUN1.SGM
14AUN1
48868
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20050 Filed 8–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0967]
Intent To Exempt Certain Unclassified,
Class II, and Class I Reserved Medical
Devices From Premarket Notification
Requirements; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Intent to Exempt Certain Unclassified,
Class II, and Class I Reserved Medical
Devices from Premarket Notification
Requirements,’’ which updates an
earlier guidance of the same title
published in the Federal Register on
July 1, 2015. This guidance describes
FDA’s intent to exempt certain
unclassified medical devices (that FDA
intends to classify into class I or II),
certain class II medical devices, and
certain class I medical devices from
premarket notification requirements.
Due to an administrative error, certain
comments to this Docket were not
considered prior to the July 1, 2015,
guidance publication. These comments
have now been considered. FDA
believes additional devices and product
codes are sufficiently well understood
and do not require premarket
notification to assure their safety and
effectiveness. As such, FDA is updating
and adding these to the guidance.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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18:50 Aug 13, 2015
Jkt 235001
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Intent to Exempt
Certain Unclassified, Class II, and Class
I Reserved Medical Devices from
Premarket Notification Requirements’’
to the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Angela C. Krueger, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring,
MD 20993–0002, 301–796–6380.
SUPPLEMENTARY INFORMATION:
I. Background
In the commitment letter (section 1.G
of the Performance Goals and
Procedures) that was drafted as part of
the reauthorization process for the
Medical Device User Fee Amendments
of 2012, part of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144), FDA committed
to identifying low-risk medical devices
to exempt from premarket notification
requirements. This guidance describes
FDA’s intent to exempt certain
unclassified medical devices (that FDA
intends to classify into class I or II),
certain class II medical devices, and
certain class I medical devices (that no
longer meet the ‘‘reserved’’ criteria in
section 510(l) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(l)))
from premarket notification
requirements. FDA believes the devices
and product codes being added to this
guidance document are sufficiently well
understood and do not require 510(k)
notification to assure their safety and
effectiveness.
The draft of this guidance was made
available in the Federal Register on
August 1, 2014 (79 FR 44804). The
comment period closed on September
30, 2014. FDA received 55 sets of
comments on the draft guidance. FDA
published a final guidance on July 1,
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
2015 (80 FR 37633). However, due to an
administrative error, certain comments
were not considered prior to the July 1,
2015, guidance publication. These
comments have now been considered,
and, based on that review, FDA is
updating and adding certain devices
and product codes to the guidance.
These comments requested that FDA
include approximately 390 additional
product codes in the guidance. Of these
product codes, more than 110 were ones
regulated by the Office of In Vitro
Diagnostics and Radiological Health,
which were outside of the scope of
FDA’s review to identify low-risk
devices to ultimately exempt from
premarket notification requirements.
Additionally, for approximately 75 of
the product codes, the comments noted
that additional controls, such as
conformance to recognized standards,
would be necessary if 510(k)s were not
submitted for these devices. Because the
imposition of such controls would go
beyond the scope of this guidance, FDA
is not adding these device types and
product codes to the guidance.
The comments also requested the
addition of 18 product codes to the
guidance that were either already in the
final guidance published on July 1,
2015, exempt from premarket
notification, or for which FDA is
currently exercising enforcement
discretion (Ref. 1). For example, more
than 30 comments spoke to the
inclusion of product code NUQ (Pad,
Menstrual, Reusable), which was
included in the draft guidance
document, and remained in the final
guidance document issued July 1, 2015.
FDA has considered the remaining
product codes proposed in the
comments and has determined that the
following eight additional product
codes should be included in the
guidance document: Product code DTL,
Adaptor, Stopcock, Manifold, Fitting,
Cardiopulmonary Bypass (see 21 CFR
870.4290—Cardiopulmonary bypass
adaptor, stopcock, manifold, or fitting);
product code OCY, Endoscopic
Guidewire, Gastroenterology-urology
(see 21 CFR 876.1500—Endoscope and
accessories); product code KOE, Dilator,
urethral (see 21 CFR 876.5520—Urethral
dilator); product code FTA, Light,
Surgical, Accessories (see 21 CFR
878.4580—Surgical lamp); product code
GZM, Analyzer, Rigidity (see 21 CFR
882.1020—Rigidity analyzer); product
code GZO, Device, Galvanic Skin
Response Measurement (see 21 CFR
882.1540—Galvanic skin response
measurement device); product code
HCJ, Device, Skin Potential
Measurement (see 21 CFR 882.1560—
Skin potential measurement device);
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48867-48868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20050]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
National Mammography Quality Assurance Advisory Committee,
Renewal
AGENCY: Food and Drug Administration, 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 6, 2017.
DATES: Authority for the National Mammography Quality Assurance
Advisory Committee will expire on July 6, 2017 unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg 66, Rm. 1643, Silver Spring, MD, 20993,
Sara.Anderson@fda.hhs.gov, 301 796-7047.
SUPPLEMENTARY INFORMATION: Under 41 CFR 102-3.65 and approval by the
Department of Health and Human Services under 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 is a statutory Federal advisory committee established to
provide advice to the Commissioner.
The Secretary and, by delegation, the Assistant Secretary for the
Office of Public Health and Science, and the Commissioner of Food and
Drugs are 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 of Food and Drugs in discharging their responsibilities
with respect to establishing a mammography facilities certification
program.
The Committee shall advise the Food and Drug Administration 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 four
years. Almost all non-Federal members of this committee serve as
Special Government Employees. The core of voting members shall include
at least 4 individuals from among national breast cancer or consumer
health organizations with expertise in mammography, and at least 2
practicing physicians who provide mammography services. In addition to
the voting members, the Committee shall include 2 nonvoting industry
representatives 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/ucm124611.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
[[Page 48868]]
amendment will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20050 Filed 8-13-15; 8:45 am]
BILLING CODE 4164-01-P
