80_FR_49024 80 FR 48867 - National Mammography Quality Assurance Advisory Committee, Renewal

80 FR 48867 - National Mammography Quality Assurance Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 157 (August 14, 2015)

Page Range48867-48868
FR Document2015-20050

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.

Federal Register, Volume 80 Issue 157 (Friday, August 14, 2015) 
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48867-48868]
From the Federal Register Online  [www.thefederalregister.org]
[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 http://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 http://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

Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48867 ANNUAL BURDEN ESTIMATES Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response Registration Screens ....................................................................................... 299 1 0.15 44.85 Estimated Total Annual Burden years beyond the charter expiration E. Establishing a mechanism to Hours: 45. date. The new charter will be in effect investigate consumer complaints; until July 6, 2017. F. Reporting new developments Additional Information DATES: Authority for the National concerning breast imaging which should Copies of the proposed collection may Mammography Quality Assurance be considered in the oversight of be obtained by writing to The Advisory Committee will expire on July mammography facilities; Administration for Children and 6, 2017 unless the Commissioner G. Determining whether there exists a Families, Office of Information Services, formally determines that renewal is in shortage of mammography facilities in 370 L’Enfant Promenade SW., the public interest. rural and health professional shortage Washington, DC 20447, Attn: ACF FOR FURTHER INFORMATION CONTACT: Sara areas and determining the effects of Reports Clearance Officer. J. Anderson, Center for Devices and personnel on access to the services of OMB Comment Radiological Health, Food and Drug such facilities in such areas; Administration, 10903 New Hampshire H. Determining whether there will OMB is required to make a decision Ave., Bldg 66, Rm. 1643, Silver Spring, exist a sufficient number of medical concerning the collection of information MD, 20993, physicists after October 1, 1999; and between 30 and 60 days after Sara.Anderson@fda.hhs.gov, 301 796– I. Determining the costs and benefits publication of this document in the 7047. of compliance with these requirements. Federal Register. Therefore, a comment is best assured of having its full effect SUPPLEMENTARY INFORMATION: Under 41 The Committee shall consist of a core if OMB receives it within 30 days of CFR 102–3.65 and approval by the of 15 members, including the Chair. publication. Written comments and Department of Health and Human Members and the Chair are selected by recommendations for the proposed Services under 45 CFR part 11 and by the Commissioner or designee from information collection should be sent the General Services Administration, among physicians, practitioners, and directly to the following: Office of FDA is announcing the renewal of the other health professionals, whose Management and Budget, Paperwork National Mammography Quality clinical practice, research Reduction Project, Email: OIRA_ Assurance Advisory Committee. The specialization, or professional expertise SUBMISSION@OMB.EOP.GOV, Attn: committee is a statutory Federal includes a significant focus on Desk Officer for the Administration for advisory committee established to mammography. Members will be invited Children and Families. provide advice to the Commissioner. to serve for overlapping terms of up to The Secretary and, by delegation, the four years. Almost all non-Federal Robert Sargis, Assistant Secretary for the Office of members of this committee serve as Reports Clearance Officer. Public Health and Science, and the Special Government Employees. The [FR Doc. 2015–20121 Filed 8–13–15; 8:45 am] Commissioner of Food and Drugs are core of voting members shall include at BILLING CODE 4184–01–P charged with the administration of the least 4 individuals from among national Federal Food, Drug and Cosmetic Act breast cancer or consumer health and various provisions of the Public organizations with expertise in DEPARTMENT OF HEALTH AND Health Service Act. The Mammography mammography, and at least 2 practicing HUMAN SERVICES Quality Standards Act of 1992 amends physicians who provide mammography the Public Health Service Act to services. In addition to the voting Food and Drug Administration establish national uniform quality and members, the Committee shall include 2 [Docket No. FDA–2015–N–0001] safety standards for mammography nonvoting industry representatives who facilities. The National Mammography have expertise in mammography National Mammography Quality Quality Assurance Advisory Committee equipment. The Committee may include Assurance Advisory Committee, advises the Secretary and, by delegation, one technically qualified member, Renewal the Commissioner of Food and Drugs in selected by the Commissioner or discharging their responsibilities with designee, who is identified with AGENCY: Food and Drug Administration, respect to establishing a mammography HHS. consumer interests. facilities certification program. ACTION:Notice; renewal of advisory The Committee shall advise the Food Further information regarding the committee. and Drug Administration on: most recent charter and other A. Developing appropriate quality information can be found at http://www. SUMMARY: The Food and Drug standards and regulations for fda.gov/AdvisoryCommittees/ Administration (FDA) is announcing the CommitteesMeetingMaterials/Radiation- asabaliauskas on DSK5VPTVN1PROD with NOTICES mammography facilities; renewal of the National Mammography B. Developing appropriate standards EmittingProducts/National Quality Assurance Advisory Committee and regulations for bodies accrediting MammographyQualityAssurance by the Commissioner of Food and Drugs mammography facilities under this AdvisoryCommittee/ucm124611.htm or (the Commissioner). The Commissioner program; by contacting the Designated Federal has determined that it is in the public C. Developing regulations with Officer (see FOR FURTHER INFORMATION interest to renew the National respect to sanctions; CONTACT). In light of the fact that no Mammography Quality Assurance D. Developing procedures for change has been made to the committee Advisory Committee for an additional 2 monitoring compliance with standards; name or description of duties, no VerDate Sep<11>2014 18:50 Aug 13, 2015 Jkt 235001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 SUPPLEMENTARY INFORMATION section for 2015 (80 FR 37633). However, due to an 14.100. information on electronic access to the administrative error, certain comments This document is issued under the guidance. Submit written requests for a were not considered prior to the July 1, Federal Advisory Committee Act (5 single hard copy of the guidance 2015, guidance publication. These U.S.C. app. 2). For general information document entitled ‘‘Intent to Exempt comments have now been considered, related to FDA advisory committees, Certain Unclassified, Class II, and Class and, based on that review, FDA is please visit us at http://www.fda.gov/ I Reserved Medical Devices from updating and adding certain devices AdvisoryCommittees/default.htm. Premarket Notification Requirements’’ and product codes to the guidance. Dated: August 10, 2015. to the Office of the Center Director, These comments requested that FDA Guidance and Policy Development, include approximately 390 additional Jill Hartzler Warner, Center for Devices and Radiological product codes in the guidance. Of these Associate Commissioner for Special Medical product codes, more than 110 were ones Programs. Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, regulated by the Office of In Vitro [FR Doc. 2015–20050 Filed 8–13–15; 8:45 am] Diagnostics and Radiological Health, Rm. 5431, Silver Spring, MD 20993– BILLING CODE 4164–01–P 0002. Send one self-addressed adhesive which were outside of the scope of label to assist that office in processing FDA’s review to identify low-risk your request. devices to ultimately exempt from DEPARTMENT OF HEALTH AND premarket notification requirements. HUMAN SERVICES Submit electronic comments on the guidance to http://www.regulations.gov. Additionally, for approximately 75 of Submit written comments to the the product codes, the comments noted Food and Drug Administration Division of Dockets Management (HFA– that additional controls, such as [Docket No. FDA–2014–D–0967] 305), Food and Drug Administration, conformance to recognized standards, 5630 Fishers Lane, Rm. 1061, Rockville, would be necessary if 510(k)s were not Intent To Exempt Certain Unclassified, submitted for these devices. Because the MD 20852. Identify comments with the Class II, and Class I Reserved Medical imposition of such controls would go docket number found in brackets in the Devices From Premarket Notification beyond the scope of this guidance, FDA heading of this document. Requirements; Guidance for Industry is not adding these device types and and Food and Drug Administration FOR FURTHER INFORMATION CONTACT: product codes to the guidance. Staff; Availability Angela C. Krueger, Center for Devices The comments also requested the and Radiological Health, Food and Drug addition of 18 product codes to the AGENCY: Food and Drug Administration, Administration, 10903 New Hampshire HHS. guidance that were either already in the Ave., Bldg. 66, Rm. 1666, Silver Spring, final guidance published on July 1, ACTION: Notice. MD 20993–0002, 301–796–6380. 2015, exempt from premarket SUPPLEMENTARY INFORMATION: notification, or for which FDA is SUMMARY: The Food and Drug Administration (FDA) is announcing the I. Background currently exercising enforcement availability of a guidance entitled discretion (Ref. 1). For example, more In the commitment letter (section 1.G than 30 comments spoke to the ‘‘Intent to Exempt Certain Unclassified, of the Performance Goals and Class II, and Class I Reserved Medical inclusion of product code NUQ (Pad, Procedures) that was drafted as part of Menstrual, Reusable), which was Devices from Premarket Notification the reauthorization process for the Requirements,’’ which updates an included in the draft guidance Medical Device User Fee Amendments document, and remained in the final earlier guidance of the same title of 2012, part of the Food and Drug published in the Federal Register on guidance document issued July 1, 2015. Administration Safety and Innovation FDA has considered the remaining July 1, 2015. This guidance describes Act (Pub. L. 112–144), FDA committed product codes proposed in the FDA’s intent to exempt certain to identifying low-risk medical devices comments and has determined that the unclassified medical devices (that FDA to exempt from premarket notification following eight additional product intends to classify into class I or II), requirements. This guidance describes codes should be included in the certain class II medical devices, and FDA’s intent to exempt certain guidance document: Product code DTL, certain class I medical devices from unclassified medical devices (that FDA Adaptor, Stopcock, Manifold, Fitting, premarket notification requirements. intends to classify into class I or II), Cardiopulmonary Bypass (see 21 CFR Due to an administrative error, certain certain class II medical devices, and 870.4290—Cardiopulmonary bypass comments to this Docket were not certain class I medical devices (that no adaptor, stopcock, manifold, or fitting); considered prior to the July 1, 2015, longer meet the ‘‘reserved’’ criteria in product code OCY, Endoscopic guidance publication. These comments section 510(l) of the Federal Food, Drug, Guidewire, Gastroenterology-urology have now been considered. FDA and Cosmetic Act (21 U.S.C. 360(l))) (see 21 CFR 876.1500—Endoscope and believes additional devices and product from premarket notification accessories); product code KOE, Dilator, codes are sufficiently well understood requirements. FDA believes the devices urethral (see 21 CFR 876.5520—Urethral and do not require premarket and product codes being added to this dilator); product code FTA, Light, notification to assure their safety and guidance document are sufficiently well Surgical, Accessories (see 21 CFR effectiveness. As such, FDA is updating understood and do not require 510(k) 878.4580—Surgical lamp); product code and adding these to the guidance. notification to assure their safety and GZM, Analyzer, Rigidity (see 21 CFR asabaliauskas on DSK5VPTVN1PROD with NOTICES DATES: Submit either electronic or effectiveness. 882.1020—Rigidity analyzer); product written comments on this guidance at The draft of this guidance was made code GZO, Device, Galvanic Skin any time. General comments on Agency available in the Federal Register on Response Measurement (see 21 CFR guidance documents are welcome at any August 1, 2014 (79 FR 44804). The 882.1540—Galvanic skin response time. comment period closed on September measurement device); product code ADDRESSES: An electronic copy of the 30, 2014. FDA received 55 sets of HCJ, Device, Skin Potential guidance document is available for comments on the draft guidance. FDA Measurement (see 21 CFR 882.1560— download from the Internet. See the published a final guidance on July 1, Skin potential measurement device); VerDate Sep<11>2014 18:50 Aug 13, 2015 Jkt 235001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\14AUN1.SGM 14AUN1


Document Created: 2018-02-23 10:58:55
Document Modified: 2018-02-23 10:58:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; renewal of advisory committee.
DatesAuthority 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.
ContactSara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 66, Rm. 1643, Silver Spring, MD, 20993, [email protected], 301 796-7047.
FR Citation80 FR 48867 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR