83_FR_45431 83 FR 45258 - Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee

83 FR 45258 - Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 173 (September 6, 2018)

Page Range45258-45259
FR Document2018-19354

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

Federal Register, Volume 83 Issue 173 (Thursday, September 6, 2018) 
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45258-45259]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3207]


Request for Nominations of Voting Members on a Public Advisory 
Committee; National Mammography Quality Assurance Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members to serve on the National Mammography 
Quality Assurance Advisory Committee in the Center for Devices and 
Radiological Health. Nominations will be accepted for upcoming 
vacancies effective with this notice.
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups.

DATES: Nominations received on or before November 5, 2018, will be 
given first consideration for membership on the National Mammography 
Quality

[[Page 45259]]

Assurance Advisory Committee. Nominations received after November 5, 
2018, will be considered for nomination to the committee as later 
vacancies occur.

ADDRESSES: All nominations for membership should be submitted 
electronically by logging into the FDA Advisory Nomination Portal: 
http://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or 
by mail to Advisory Committee Oversight and Management Staff, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, 
Silver Spring, MD 20993-0002. Information about becoming a member on an 
FDA advisory committee can also be obtained by visiting FDA's website 
at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: 
    Regarding all nomination questions for membership: Sara Anderson, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver 
Spring, MD 20993, 301-796-7047, email: Sara.Anderson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members to fill upcoming vacancies on the National Mammography Quality 
Assurance Advisory Committee.

I. General Description of the Committee Duties

    The National Mammography Quality Assurance Advisory Committee 
advises the Commissioner of Food and Drugs (the Commissioner) or 
designee on: (1) Developing appropriate quality standards and 
regulations for mammography facilities; (2) developing appropriate 
standards and regulations for bodies accrediting mammography facilities 
under this program; (3) developing regulations with respect to 
sanctions; (4) developing procedures for monitoring compliance with 
standards; (5) establishing a mechanism to investigate consumer 
complaints; (6) reporting new developments concerning breast imaging 
that should be considered in the oversight of mammography facilities; 
(7) 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; (8) determining whether there will exist a 
sufficient number of medical physicists after October 1, 1999; and (9) 
determining the costs and benefits of compliance with these 
requirements.

II. Criteria for Voting Members

    The committee consists 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. 
Almost all non-Federal members of this committee serve as Special 
Government Employees. Members will be invited to serve for terms of up 
to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified persons 
for membership on the advisory committee. Self-nominations are also 
accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee, including 
current business address, telephone number, and email address if 
available and a signed copy of the Acknowledgement and Consent form 
available at the FDA Advisory Nomination Portal (see ADDRESSES). 
Nominations must specify the advisory committee for which the nominee 
is recommended. Nominations must also acknowledge that the nominee is 
aware of the nomination unless self-nominated. FDA will ask potential 
candidates to provide detailed information concerning such matters 
related to financial holdings, employment, and research grants and/or 
contracts to permit evaluation of possible sources of conflict of 
interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: August 31, 2018.
 Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19354 Filed 9-5-18; 8:45 am]
 BILLING CODE 4164-01-P

45258 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1—Continued Number of Average Number of Total annual Respondent description responses per burden per Total hours respondents responses respondent response Total .............................................................................. ........................ ........................ ........................ ........................ 150 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN ILLEGITIMATE PRODUCT 1 Number of Average Number of disclosures Total annual Respondent description burden per Total hours respondents per disclosures disclosure respondent Manufacturers and Repackagers ......................... 120 30 3,600 0.20 (12 minutes) ......... 720 Wholesale Distributors .......................................... 22 1,175 25,850 0.20 (12 minutes) ......... 5,170 Dispensers ............................................................ 8 2 16 0.20 (12 minutes) ......... 3.2 Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1 Number of Average Number of Total annual Respondent description responses per burden per Total hours respondents responses respondent response Manufacturers and Repackagers ......................................... 120 1 120 1 120 Wholesale Distributors ......................................................... 22 1 22 1 22 Dispensers ........................................................................... 8 1 8 1 8 Total .............................................................................. ........................ ........................ ........................ ........................ 150 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN ILLEGITIMATE PRODUCT TERMINATION 1 Number of Average Number of disclosures Total annual Respondent description burden per Total hours respondents per disclosures disclosure respondent Manufacturers and Repackagers ......................... 120 30 3,600 0.2 (12 minutes) ........... 720 Wholesale Distributors .......................................... 22 1,175 25,850 0.2 (12 minutes) ........... 5,170 Dispensers ............................................................ 8 2 16 0.2 (12 minutes) ........... 3.2 Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Cumulatively, the total estimated DEPARTMENT OF HEALTH AND nominations for voting members to burden is 12,086 annual hours, which HUMAN SERVICES serve on the National Mammography reflects a significant decrease. We base Quality Assurance Advisory Committee this adjustment on our experience with Food and Drug Administration in the Center for Devices and the information collection since its Radiological Health. Nominations will [Docket No. FDA–2018–N–3207] be accepted for upcoming vacancies establishment and implementation. effective with this notice. Dated: August 31, 2018. Request for Nominations of Voting FDA seeks to include the views of Leslie Kux, Members on a Public Advisory women and men, members of all racial Committee; National Mammography and ethnic groups, and individuals with Associate Commissioner for Policy. Quality Assurance Advisory and without disabilities on its advisory [FR Doc. 2018–19351 Filed 9–5–18; 8:45 am] daltland on DSKBBV9HB2PROD with NOTICES Committee committees and, therefore, encourages BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, nominations of appropriately qualified HHS. candidates from these groups. ACTION: Notice. DATES: Nominations received on or before November 5, 2018, will be given SUMMARY: The Food and Drug first consideration for membership on Administration (FDA) is requesting the National Mammography Quality VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1

Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45259 Assurance Advisory Committee. II. Criteria for Voting Members guidance for industry entitled ‘‘Allergic Nominations received after November 5, The committee consists of a core of 15 Rhinitis: Developing Drug Products for 2018, will be considered for nomination members, including the Chair. Members Treatment.’’ The purpose of this to the committee as later vacancies and the Chair are selected by the guidance is to assist sponsors in the occur. Commissioner or designee from among development of drug products for the ADDRESSES: All nominations for physicians, practitioners, and other treatment of allergic rhinitis in children membership should be submitted health professionals, whose clinical and adults. The guidance addresses electronically by logging into the FDA practice, research specialization, or issues of trial design, effectiveness, and Advisory Nomination Portal: http:// professional expertise includes a safety for new products being developed www.accessdata.fda.gov/scripts/ significant focus on mammography. for the treatment of seasonal allergic FACTRSPortal/FACTRS/index.cfm or by Almost all non-Federal members of this rhinitis (SAR) and perennial allergic mail to Advisory Committee Oversight committee serve as Special Government rhinitis (PAR). This guidance and Management Staff, Food and Drug Employees. Members will be invited to incorporates the comments received for Administration, 10903 New Hampshire serve for terms of up to 4 years. and finalizes the draft guidance of the Ave., Bldg. 32, Rm. 5103, Silver Spring, same name issued on February 16, 2016. MD 20993–0002. Information about III. Nomination Procedures DATES: The announcement of the becoming a member on an FDA advisory Any interested person may nominate guidance is published in the Federal committee can also be obtained by one or more qualified persons for Register on September 6, 2018. visiting FDA’s website at http:// membership on the advisory committee. ADDRESSES: You may submit either www.fda.gov/AdvisoryCommittees/ Self-nominations are also accepted. electronic or written comments on default.htm. Nominations must include a current, Agency guidances at any time as FOR FURTHER INFORMATION CONTACT: complete résumé or curriculum vitae for follows: Regarding all nomination questions each nominee, including current business address, telephone number, Electronic Submissions for membership: Sara Anderson, Center for Devices and Radiological Health, and email address if available and a Submit electronic comments in the Food and Drug Administration, 10903 signed copy of the Acknowledgement following way: New Hampshire Ave., Bldg. 66, Rm. and Consent form available at the FDA • Federal eRulemaking Portal: G616, Silver Spring, MD 20993, 301– Advisory Nomination Portal (see https://www.regulations.gov. Follow the 796–7047, email: Sara.Anderson@ ADDRESSES). Nominations must specify instructions for submitting comments. fda.hhs.gov. the advisory committee for which the Comments submitted electronically, SUPPLEMENTARY INFORMATION: FDA is nominee is recommended. Nominations including attachments, to https:// requesting nominations for voting must also acknowledge that the www.regulations.gov will be posted to members to fill upcoming vacancies on nominee is aware of the nomination the docket unchanged. Because your the National Mammography Quality unless self-nominated. FDA will ask comment will be made public, you are Assurance Advisory Committee. potential candidates to provide detailed solely responsible for ensuring that your information concerning such matters comment does not include any I. General Description of the Committee related to financial holdings, confidential information that you or a Duties employment, and research grants and/or third party may not wish to be posted, The National Mammography Quality contracts to permit evaluation of such as medical information, your or Assurance Advisory Committee advises possible sources of conflict of interest. anyone else’s Social Security number, or the Commissioner of Food and Drugs This notice is issued under the confidential business information, such (the Commissioner) or designee on: (1) Federal Advisory Committee Act (5 as a manufacturing process. Please note Developing appropriate quality U.S.C. app. 2) and 21 CFR part 14, that if you include your name, contact standards and regulations for relating to advisory committees. information, or other information that mammography facilities; (2) developing Dated: August 31, 2018. identifies you in the body of your appropriate standards and regulations Leslie Kux, comments, that information will be for bodies accrediting mammography Associate Commissioner for Policy. posted on https://www.regulations.gov. facilities under this program; (3) • If you want to submit a comment [FR Doc. 2018–19354 Filed 9–5–18; 8:45 am] developing regulations with respect to with confidential information that you BILLING CODE 4164–01–P sanctions; (4) developing procedures for do not wish to be made available to the monitoring compliance with standards; public, submit the comment as a (5) establishing a mechanism to written/paper submission and in the DEPARTMENT OF HEALTH AND investigate consumer complaints; (6) manner detailed (see ‘‘Written/Paper HUMAN SERVICES reporting new developments concerning Submissions’’ and ‘‘Instructions’’). breast imaging that should be Food and Drug Administration considered in the oversight of Written/Paper Submissions mammography facilities; (7) [Docket No. FDA–2000–D–0277] Submit written/paper submissions as determining whether there exists a follows: shortage of mammography facilities in Allergic Rhinitis: Developing Drug • Mail/Hand delivery/Courier (for rural and health professional shortage Products for Treatment; Guidance for written/paper submissions): Dockets areas and determining the effects of Industry; Availability Management Staff (HFA–305), Food and daltland on DSKBBV9HB2PROD with NOTICES personnel on access to the services of AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers such facilities in such areas; (8) HHS. Lane, Rm. 1061, Rockville, MD 20852. determining whether there will exist a ACTION: Notice of availability. • For written/paper comments sufficient number of medical physicists submitted to the Dockets Management after October 1, 1999; and (9) SUMMARY: The Food and Drug Staff, FDA will post your comment, as determining the costs and benefits of Administration (FDA or Agency) is well as any attachments, except for compliance with these requirements. announcing the availability of a information submitted, marked and VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1


Document Created: 2018-09-05 23:56:16
Document Modified: 2018-09-05 23:56:16
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.
DatesNominations received on or before November 5, 2018, will be given first consideration for membership on the National Mammography Quality Assurance Advisory Committee. Nominations received after November 5, 2018, will be considered for nomination to the committee as later vacancies occur.
ContactRegarding all nomination questions for membership: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993, 301-796-7047, email: [email protected]
FR Citation83 FR 45258 
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