[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 718-720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) 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 advisory committee nomination 
Applications.

DATES: Submit either electronic or written comments on the collection 
of information by March 9, 2020.

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, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 9, 2020. 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.

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'').

Written/Paper Submissions

    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 identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-0366 for ``Advisory Committee Nomination Applications.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed

[[Page 719]]

except in accordance with 21 CFR 10.20 and other applicable disclosure 
law. For more information about FDA's posting of comments to public 
dockets, see 80 FR 56469, September 18, 2015, or access the information 
at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

[[Page 720]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
    21 CFR Part 14; Subpart E--Members of        Number of     responses per   Total annual           Average burden per response           Total hours
             Advisory Committees                respondents     respondent       responses
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Advisory Committee Membership Nominations...             391               1             391  0.25 (15 minutes).........................              98
Representative Member Submission of Updated               54               1              54  0.25 (15 minutes).........................              14
 Information.
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    Total...................................  ..............  ..............             445  ..........................................             112
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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 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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00041 Filed 1-6-20; 8:45 am]
 BILLING CODE 4164-01-P