82 FR 23583 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advisory Committee Nomination Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 98 (May 23, 2017)

The Food and Drug Administration (FDA or we) 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 (the PRA).

[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23583-23584]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10531]


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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 or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by June 
22, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number, 0910-NEW, 
and title, ``FDA Advisory Committee Membership Nominations.'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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

FDA Advisory Committee Membership Nominations--OMB Control Number 0910-
NEW

    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 Final Rule notes 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 Web site 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 Web site, 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 
publicly post to FDA's Web site the CV submitted as part of their 
nomination materials if the nominee is selected to serve on an advisory 
committee. In the past, FDA has generally posted the CVs of FDA 
advisory committee members publicly on http://www.fda.gov/AdvisoryCommittees/ after reviewing the CVs and redacting information 
that appeared to be confidential. However,

[[Page 23584]]

in furtherance of FDA's goal of ensuring transparency regarding the 
qualifications of individuals selected to serve on FDA advisory 
committees, and in recognition that individual advisory committee 
members are best situated to evaluate the confidentiality of 
information contained in their CVs, including any considerations raised 
by their relationships and agreements with third parties, FDA will now 
be requiring that all CVs submitted as part of the nomination process 
for positions on FDA advisory committees be accompanied by a written 
consent form stating that, if the nominee is accepted as a member of an 
FDA advisory committee, the nominee consents to the publication of the 
nominee's CV to FDA's Web site, without FDA removing or redacting any 
information. 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 in order for the nomination to be 
considered complete.
    All nominations for new advisory committee members will be required 
to be submitted through FDA's Web site 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 February 6, 2017 (82 FR 9383), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received in support of the 
information collection and recommended no changes to the Agency's 
burden estimate. On our own initiative, however, we have revised the 
estimate provided in our 60 day notice to reflect an increase of 23.5 
burden hours and 94 responses. While we believe our original burden 
estimate accurately reflects the time burden associated with providing 
the specific data elements, but we have increased the number of 
respondents to the collection to include Industry Representative 
members of FDA advisory committees.
    We therefore estimate the burden of the information collection as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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   21 CFR part 14; subpart E--                       Number of
 members of advisory  committees     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Advisory Committee Membership                583               1             583            0.25          145.75
 Nominations....................                                                    (15 minutes)
Representative Member Submission              64               1              64            0.25            16.0
 of Updated Information.........                                                    (15 minutes)
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    Total.......................  ..............  ..............             647  ..............          161.75
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\1\ There are no capital or operating and maintenance costs associated with the information collection.

    Based on a review of data, we received 638 nominations for 
membership to FDA advisory committees in Fiscal Year (FY) 2011; we 
received 603 nominations in FY 2012; we received 622 in FY 2013; we 
received 545 in FY 2014; and we received 505 nominations in FY 2015. By 
averaging the number of nominations received annually over the past 5 
years, we estimate there are approximately 583 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 (583) equals 145.75 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 64 
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 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 
16 annual hours.

    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10531 Filed 5-22-17; 8:45 am]
 BILLING CODE 4164-01-P