Request for Nominations on the National Mammography Quality Assurance Advisory Committee, 1507-1508 [2021-00122]

Download as PDF 1507 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices the SOPs for said program. The form collects the following: (1) Name; (2) signature; (3) date; and (4) center. (G) Program evaluation—Participants in FDA fellowship and traineeship programs will be asked to complete an evaluation providing program data that will be synthesized into program reports on the overall effectiveness of the program. The evaluation collects the following information: (1) Demographic data; (2) expectations of fellowship or training program; (3) administration processes and support to fellow or trainee; (4) FDA retention and plans of fellow or trainee; (5) training and education completed; and (6) professional/research goals. The purpose of this evaluation is to assess the effectiveness of the program and feedback from participants to improve the quality of the experience. 4. To end the program, a nonemployee must submit the exit checklist—Participants in FDA fellowship and traineeship programs may be asked to complete the exit checklist to manage the exit process and return of FDA property. The exit checklist guides the exit process for the following operational components: (1) Access key/pass; (2) accountable property; (3) system applications inactive; (4) library materials; (5) government-issued documents (i.e., passports); (6) personal identity verification card/badge; (7) borrowed records; (8) employee records; and (9) information technology accounts. All exit information will be entered to terminate access to any FDA information. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses (15 (15 (15 (15 minutes) minutes) minutes) minutes) Total hours New Non-Employee Data Form ............................... Proof of Health Insurance ........................................ Emergency Contact Information .............................. UFMS Supplier and Site Information for Stipend Payments, Financial Information. CONCUR GOV New Traveler Profile ...................... Absence Recording Form ........................................ Personal Custody Property Record ......................... FDA Health Summary .............................................. Discovery and Invention Form ................................. Training Development Plan ..................................... Final Project Report ................................................. Training Request ...................................................... Travel Request ......................................................... LMS Access ............................................................. SOP Verification ....................................................... Program Evaluation ................................................. Exit Checklist ........................................................... 1,220 600 1,220 600 1 1 1 1 1 1 1 1 0.25 0.25 0.25 0.25 ...... ...... ...... ...... 305 150 305 150 620 1,220 1,220 1,220 1,220 1,220 1,220 610 610 1,220 1,220 1,220 1,220 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0.25 (15 minutes) ...... 0.25 (15 minutes) ...... 0.25 (15 minutes) ...... 1 ................................ 1 ................................ 1 ................................ 1 ................................ 0.5 (30 minutes) ........ 0.5 (30 minutes) ........ 0.25 (15 minutes) ...... 0.25 (15 minutes) ...... 0.5 (30 minutes) ........ 1 ................................ 155 305 305 1,220 1,220 1,220 1,220 305 305 305 305 610 1,220 Total .................................................................. 9,605 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA published a 60-day notice for this information collection on November 22, 2019 (84 FR 64536). FDA is reopening the 60-day comment period in order to satisfy PRA requirements. No changes have been made to the information collection. Dated: January 4, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–00120 Filed 1–7–21; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0417] Request for Nominations on the National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. BILLING CODE 4164–01–P The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the National SUMMARY: tkelley on DSKBCP9HB2PROD with NOTICES Average burden per response VerDate Sep<11>2014 21:23 Jan 07, 2021 Jkt 253001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. Any industry organization interested in participating in the selection of appropriate nonvoting members to represent industry interests must send a letter stating that interest to FDA by February 8, 2021 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by February 8, 2021. DATES: All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nominations should be sent to Margaret Ames (see FOR FURTHER INFORMATION ADDRESSES: E:\FR\FM\08JAN1.SGM 08JAN1 1508 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices All nominations for nonvoting industry representatives should be submitted electronically by accessing the FDA Advisory Committee Membership 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 of 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: Margaret Ames, Division of Management Services, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993, 301–796– 5960, email: margaret.ames@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for nonvoting industry representative on the National Mammography Quality Assurance Advisory Committee: tkelley on DSKBCP9HB2PROD with NOTICES CONTACT). I. General Description of the Committee Duties The Committee shall advise FDA 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 these 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. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA VerDate Sep<11>2014 21:23 Jan 07, 2021 Jkt 253001 contact (see FOR FURTHER INFORMATION within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current re´sume´s. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. CONTACT) III. Nomination Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nominations must include a current, complete re´sume´ or curriculum vitae for each nominee including current business address and telephone number, 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 also 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 forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.) 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. Specifically, in this document, nominations for a nonvoting representative of industry interests are encouraged from the mammography manufacturing industry. 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Dated: January 4, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–00122 Filed 1–7–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1031] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations 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 provisions associated with FDA recalls for products regulated by the Agency. DATES: Submit either electronic or written comments on the collection of information by March 9, 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 March 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 9, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: 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 E:\FR\FM\08JAN1.SGM 08JAN1

Agencies

[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1507-1508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0417]


Request for Nominations on the 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 that any 
industry organizations interested in participating in the selection of 
nonvoting industry representatives to serve on the National Mammography 
Quality Assurance Advisory Committee in the Center for Devices and 
Radiological Health notify FDA in writing. FDA is also requesting 
nominations for nonvoting industry representatives to serve on the 
National Mammography Quality Assurance Advisory Committee. A nominee 
may either be self-nominated or nominated by an organization to serve 
as a nonvoting industry representative. Nominations will be accepted 
for current vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of appropriate nonvoting members to represent industry 
interests must send a letter stating that interest to FDA by February 
8, 2021 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by February 8, 2021.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nominations should be sent to Margaret Ames 
(see FOR FURTHER INFORMATION

[[Page 1508]]

CONTACT). All nominations for nonvoting industry representatives should 
be submitted electronically by accessing the FDA Advisory Committee 
Membership 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 of 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: Margaret Ames, Division of Management 
Services, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver 
Spring, MD 20993, 301-796-5960, email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for 
nonvoting industry representative on the National Mammography Quality 
Assurance Advisory Committee:

I. General Description of the Committee Duties

    The Committee shall advise FDA 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 these 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. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations; and a list of all nominees 
along with their current r[eacute]sum[eacute]s. The letter will also 
state that it is the responsibility of the interested organizations to 
confer with one another and to select a candidate, within 60 days after 
the receipt of the FDA letter, to serve as the nonvoting member to 
represent industry interests for the committee. The interested 
organizations are not bound by the list of nominees in selecting a 
candidate. However, if no individual is selected within 60 days, the 
Commissioner will select the nonvoting member to represent industry 
interests.

III. Nomination Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee including 
current business address and telephone number, 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 also 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 
forward all nominations to the organizations expressing interest in 
participating in the selection process for the committee. (Persons who 
nominate themselves as nonvoting industry representatives will not 
participate in the selection process.)
    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. Specifically, in 
this document, nominations for a nonvoting representative of industry 
interests are encouraged from the mammography manufacturing industry.
    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: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00122 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P


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