Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee, 45258-45259 [2018-19354]

Download as PDF 45258 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1—Continued Respondent description Total .............................................................................. 1 There Number of respondents Number of responses per respondent Total annual responses Average burden per response ........................ ........................ ........................ ........................ Total hours 150 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 respondents Respondent description Number of disclosures per respondent Average burden per disclosure Total annual disclosures Total hours Manufacturers and Repackagers ......................... Wholesale Distributors .......................................... Dispensers ............................................................ 120 22 8 30 1,175 2 3,600 25,850 16 0.20 (12 minutes) ......... 0.20 (12 minutes) ......... 0.20 (12 minutes) ......... 720 5,170 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 respondents Respondent description Number of responses per respondent Average burden per response Total annual responses Total hours Manufacturers and Repackagers ......................................... Wholesale Distributors ......................................................... Dispensers ........................................................................... 120 22 8 1 1 1 120 22 8 1 1 1 120 22 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 respondents Respondent description Average burden per disclosure Total annual disclosures Total hours Manufacturers and Repackagers ......................... Wholesale Distributors .......................................... Dispensers ............................................................ 120 22 8 30 1,175 2 3,600 25,850 16 0.2 (12 minutes) ........... 0.2 (12 minutes) ........... 0.2 (12 minutes) ........... 720 5,170 3.2 Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 1 There daltland on DSKBBV9HB2PROD with NOTICES Number of disclosures per respondent are no capital costs or operating and maintenance costs associated with this collection of information. Cumulatively, the total estimated burden is 12,086 annual hours, which reflects a significant decrease. We base this adjustment on our experience with the information collection since its establishment and implementation. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: August 31, 2018. Leslie Kux, Associate Commissioner for Policy. Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee [FR Doc. 2018–19351 Filed 9–5–18; 8:45 am] Food and Drug Administration [Docket No. FDA–2018–N–3207] BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting SUMMARY: VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES 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: https:// 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 https:// 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. VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 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 re´sume´ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES 45259 guidance for industry entitled ‘‘Allergic Rhinitis: Developing Drug Products for Treatment.’’ The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on February 16, 2016. DATES: The announcement of the guidance is published in the Federal Register on September 6, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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’’). Food and Drug Administration Written/Paper Submissions [Docket No. FDA–2000–D–0277] 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 Allergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45258-45259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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: 
https://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 https://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: [email protected].

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

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