[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------------------------------
Total....................................... .............. .............. 800 ........................................... 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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