[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Pages 9294-9296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02961]


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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; Food and Drug Administration Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the 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 the information collection 
associated with certain FDA advisory committee activities.

DATES: Either electronic or written comments on the collection of 
information must be submitted by April 14, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 14, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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 ``FDA Advisory Committees.'' 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, 240-
402-7500.
     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 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601

[[Page 9295]]

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 Committees; Information Collection Activities

OMB Control No. 0910-0833--Revision

    This information collection supports certain FDA advisory committee 
administrative activities. FDA advisory committees are established to 
advise or make recommendations on matters of public health that come 
before the Agency. The Federal Advisory Committee Act (FACA) (5 U.S.C. 
App. 2 3, Pub. L. 92-463) defines what constitutes an ``advisory 
committee'' and provides general procedures to follow for the operation 
of advisory committees. In addition, FACA is designed to assure that 
Congress and the public are kept informed with respect to the purpose, 
membership, and activities of advisory committees. FDA regulations at 
21 CFR part 14 also establish procedures applicable to its advisory 
committees.
    FACA does not specify the manner in which advisory committee 
members and staff must be appointed. (See generally 5 U.S.C. App. 2. 
See also, 41 CFR 102-3.105, and 102-3.130(a).) FDA's regulations, 
however, specify that the Commissioner ``will publish one or more 
notices in the Federal Register each year requesting nominations for 
voting members of all existing standing advisory committees'' (Sec.  
14.82(a) (21 CFR 14.82(a))). Nominations must specify the committee for 
which the nominee is recommended; include a complete curriculum vitae 
(CV); state that the nominee is aware of the nomination and willing to 
serve; and state that the nominee appears to have no conflict of 
interest that would preclude membership (Sec.  14.82(c)). To promote 
transparency, consistent with FDA and General Services Administration 
(GSA) policy (see GSA regulations encouraging Agencies to ``practice 
openness'' and suggesting that ``agencies may wish to explore the use 
of the internet to post advisory committee information . . .'' 41 CFR 
102-3.95(d)), and pursuant to a settlement agreement in the case Public 
Citizen Foundation, Inc. v. Food & Drug Administration, et al., No. 16-
cv-781 (D.D.C.), FDA is also seeking consent from nominees for FDA to 
publicly post their CVs in the event they are selected to serve on an 
FDA advisory committee.
    We are revising the information collection to include reporting 
activities associated with Guest Speakers. Guest Speakers are 
individuals who are occasionally asked to present technical and 
scientific data pertaining to matters being considered by an FDA 
advisory committee. Guest Speakers are not Government employees or are 
special Government employees participating in a non-official, non-
governmental capacity. Guest Speakers are therefore not subject to the 
conflict-of-interest statutes and regulations, including appearances of 
a conflict of interest (5 CFR 2635.502).
    Seeking transparency and openness, the Agency has determined it 
would be appropriate policy to request that a Guest Speaker voluntarily 
disclose financial interests and professional relationships to 
determine their eligibility to give a presentation at an advisory 
committee meeting.\1 2\ Disclosures reported to the Agency by Guest 
Speakers that are related to a meeting topic will be disclosed to the 
public as part of the conflict-of-interest statement at the beginning 
of a meeting. This will allow the committee to objectively evaluate the 
Guest Speaker's presentation.
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    \1\ A professional relationship is a relationship (not including 
a transactional business relationship) with a firm, association, 
society, supervisor, partner, colleague, mentor, or other persons in 
an individual's professional network. These relationships include, 
but are not limited to, employer--employee; professional--client; 
society--professional; or professional--professional.
    \2\ Although screening is voluntary for Guest Speakers, as a 
policy matter, FDA generally conditions a Guest Speaker's 
participation in the meeting upon completion of the screening form 
because an assessment of potentially disqualifying interests can 
only be completed if the necessary information requested on the form 
is disclosed to the Agency.
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    Because not all Guest Speakers are current Federal Government or 
Special Government employees bound by applicable statutory requirements 
and implementing regulations that govern financial disclosure and other 
conflicts of interest, we are instituting procedures in this regard. 
However, we intend to utilize FORM OGE 450, ``Office of Government 
Ethics Form'' and/or Form FDA 3410, to determine eligibility for 
Federal Government employees or special Government employees 
participating in an official governmental capacity to give a 
presentation to an advisory committee. To assist respondents with the 
reporting elements associated with these forms, we have prepared the 
procedural guidance document for the public, FDA advisory committee 
members, and FDA staff entitled ``Public Availability of Advisory 
Committee Members' Financial Interest Information and Waivers'' (March 
2014). The guidance is available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers and was issued consistent with our good guidance practice 
regulations in 21 CFR 10.115, which provides for comment at any time. 
For submission of Guest Speaker forms we have prepared a procedural 
staff manual guide (SMG), ``Guidelines for Clearance of Conflicts of 
Interest of Speakers Participating in Particular Matters Before an 
Advisory Committee.'' SMGs are available for download at https://www.fda.gov/about-fda/reports-manuals-forms/staff-manual-guides.
    Accordingly, we are requesting approval for information collection 
associated with FDA advisory committee membership nominations, as well 
as collection associated with determining the eligibility of Guest 
Speakers, as discussed in this supporting statement.

[[Page 9296]]

    Based on a review of data, we received 258 nominations for 
membership to FDA advisory committees in fiscal year (FY) 2018; 333 
nominations in FY 2019; 254 nominations in FY 2020; 289 nominations in 
FY 2021; and 408 nominations in FY 2022. By averaging the number of 
nominations received annually over the past 5 years, we estimate there 
are approximately 308 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 (308) 
equals 77 annual burden hours.
    We have also included a burden estimate for members who currently 
serve on FDA advisory committees who must submit an updated CV and a 
completed consent form annually. Currently, there are 532 authorized 
positions for advisory committee members. While many positions are 
filled, there are generally about 15 percent of member positions 
vacant, which leaves an average of 452 respondents. The request for the 
updated CV and consent form will be made through email communications 
by the Designated Federal Officer of the committee. The burden to the 
respondent is anticipated to be the same as the burden for new 
nominations. We estimate each response will require 15 minutes (0.25) 
for a total of 113 annual hours.
    To account for burden attendant to reporting information so that 
FDA may determine respondents' eligibility to serve as Guest Speakers, 
we include only those individuals who are not Federal Government 
employees or who are special Government employees acting in a non-
official, non-governmental capacity. Based on historical information, 
approximately 40 Guest Speakers present at advisory committee meetings 
annually. The request for the form will be made through email 
communications by the Designated Federal Officer of the committee. We 
estimate each response will require 15 minutes (0.25) for a total of 10 
annual hours.
    We estimate the burden of the collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                     Number of
 21 CFR part 14; subpart E--members of advisory      Number of     responses per   Total annual           Average burden  per response           Total
               committees activity                  respondents     respondent       responses                                                   hours
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Advisory Committee Membership Nominations.......             308               1             308  0.25 (15 minutes)..........................         77
Member Submission of Updated Information........             452               1             452  0.25 (15 minutes)..........................        113
Guest Speakers--Eligibility Form/Attestation....              40               1              40  0.25 (15 minutes)..........................         10
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    Total.......................................  ..............  ..............             800  ...........................................        200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As a result of these changes and adjustments, the information 
collection reflects a decrease in membership nominations, an increase 
in submissions of updated information, and submission of Guest Speaker 
forms for an overall increase of 355 responses and 88 hours annually.

    Dated: February 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02961 Filed 2-10-23; 8:45 am]
BILLING CODE 4164-01-P