Document ID: FDA-2017-N-0366-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Advisory
Committee Nomination Applications
Posted Date: 2020-04-16T04:00Z

[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21249-21250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08008]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0366]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Advisory Committee 
Nomination Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by May 18, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0833. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

FDA Advisory Committee Membership Nominations

OMB Control Number 0910-0833

    FDA chooses to select advisory committee members through a 
nomination process. (Appendix A to Subpart C of 41 CFR 102-3, the 
Federal Advisory Committee Management regulations note that the Federal 
Advisory Committee Act (FACA, 5 U.S.C. App. 2) does not specify the 
manner in which advisory committee members and staff must be 
appointed.) A person can self-nominate or be nominated by another 
individual. In order to identify and select qualified individuals to 
serve on its advisory committees, FDA has established an online portal, 
the FDA Advisory Committee Membership Application, to accept 
nominations of potential advisory committee members.
    The FDA Advisory Committee Membership Application accepts 
nominations for Academician/Practitioner, Consumer Representative, and 
Industry Representative membership types. Nominees who are nominated as 
scientific members should be technically qualified experts in the field 
(e.g., clinical medicine, engineering, biological and physical 
sciences, biostatistics, food sciences) and have experience 
interpreting complex data. Candidates must be able to analyze detailed 
scientific data and understand its public health significance. The 
nomination process has recently been made electronic and is available 
at http://accessdata.test.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. To submit a nomination, nominators or prospective nominees 
should upload the following documents in PDF format (see 21 CFR 
14.82(c)): (1) Curriculum vitae (CV); (2) a written confirmation that 
the nominee(s) is (are) aware of the nomination (unless self-
nominated); and (3) letters of recommendation are also suggested. For 
Consumer Representative nominations, a cover letter that lists consumer 
or community organizations for which the candidate can demonstrate 
active participation is also recommended.
    These documents are collected in order to determine if the nominee 
has the expertise in the subject matter with which the committee is 
concerned and has diverse professional education, training, and 
experience so that the committee will reflect a balanced composition of 
sufficient scientific expertise to handle the problems that come before 
it (21 CFR 14.80(b)(1)(i)). In the case of Industry and Consumer 
Representatives, information is collected to assess the candidate's 
ability to represent all interested persons within the class which the 
member is selected to represent (21 CFR 14.86).
    Each nominee should be sure to review the Agency website for 
information on:
     Vacancies, qualifications, and experience for more details 
concerning vacancies on each committee and the qualifications and 
experience common for nominees. Vacancies are updated periodically; 
therefore, one or more vacancies listed may be in the nomination 
process or a final appointment may have been made.
     Potential conflicts of interest such as financial 
holdings, employment, and research grants and/or contracts in order to 
permit evaluation of possible sources of conflict of interest.
    Also, FDA asks that prospective nominees inform us of how they 
heard about the FDA Advisory Committees (e.g., attendance at a 
professional meeting, an article in a publication, our website, while 
speaking with a friend or colleague).
    To further the Agency's goals of promoting transparency regarding 
the advisory committee process, FDA will also require that nominees to 
serve on advisory committees submit a consent form authorizing FDA to 
post, without removing or redacting any information, to FDA's public 
website (http://www.fda.gov/AdvisoryCommittees) the CV submitted as 
part of their nomination materials if the nominee is selected to serve 
on an advisory committee. The consent form requires that the nominee 
affirm that the CV does not include any confidential information, 
including information pertaining to third parties, that the nominee is 
not permitted to disclose. A nominee will be required to submit a 
signed consent form as a part of the nomination package for the 
nomination to be considered complete.
    All nominations for new advisory committee members will be required 
to be submitted through FDA's website at http://accessdata.test.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or any 
successor system, and the submission will be required to be accompanied 
by the consent form, on or after the date of OMB approval for this 
information collection.
    In the Federal Register of January 7, 2020 (85 FR 718), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received but were not 
responsive to the information collection topics solicited under the 
PRA.

[[Page 21250]]

    We therefore estimate the burden of the information collection as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
 21 CFR part 14; subpart e--members of advisory committees     Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
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Advisory Committee Membership Nominations.................             391               1             391                          0.25              98
                                                                                                                            (15 minutes)
Representative Member Submission of Updated Information...              54               1              54                          0.25              14
                                                                                                                            (15 minutes)
                                                           ---------------------------------------------------------------------------------------------
    Total.................................................  ..............  ..............             445  ............................             112
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    Based on a review of data, we received 354 nominations for 
membership to FDA advisory committees in fiscal year (FY) 2015; we 
received 510 nominations in FY 2016; we received 500 nominations in FY 
2017; we received 258 nominations in FY 2018; and we received 333 
nominations in FY 2019. By averaging the number of nominations received 
annually over the past 5 years, we estimate there are approximately 391 
respondents to the information collection. We estimate it takes 
respondents 15 minutes to complete an initial nomination, where 
accompanying documentation is already available or has been prepared in 
advance by respondents. Multiplying 15 minutes (0.25) by the number of 
respondents to the information collection (391) equals 97.75 (98 
rounded) annual burden hours.
    We have also included a burden estimate for members who currently 
serve on FDA advisory committees who are not Special Government and 
Regular Government Employees and who must submit an updated CV and an 
executed/completed consent form annually. Currently there are 54 
authorized positions for these Representative members, mostly Industry 
Representatives. While some positions are vacant, we anticipate the 
positions will be filled during the year. The request for the updated 
CV and consent form will be made through email communications by the 
Designated Federal Officer of the committee. We anticipate that the 
burden to the respondent will be the same as that for new nominations. 
We estimate each response will require 15 minutes (0.25) for a total of 
13.5 (14 rounded) annual hours.

    Dated: April 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08008 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P