82_FR_23681 82 FR 23583 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advisory Committee Nomination Applications

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)

Page Range23583-23584
FR Document2017-10531

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 Issue 98 (Tuesday, May 23, 2017) 
[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\
----------------------------------------------------------------------------------------------------------------
   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
----------------------------------------------------------------------------------------------------------------
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)
                                 -------------------------------------------------------------------------------
    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

Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices 23583 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Average User fee waivers, reductions, & refunds for drug & Number of Total annual responses per burden per Total hours biological products respondents responses respondent response Total .............................................................................. ........................ ........................ ........................ ........................ 2,630 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 18, 2017. SUPPLEMENTARY INFORMATION: In demonstrate active participation is also Anna K. Abram, compliance with 44 U.S.C. 3507, we recommended. Deputy Commissioner for Policy, Planning, have submitted the following proposed These documents are collected in Legislation, and Analysis. collection of information to OMB for order to determine if the nominee has [FR Doc. 2017–10534 Filed 5–22–17; 8:45 am] review and clearance. the expertise in the subject matter with BILLING CODE 4164–01–P which the committee is concerned and FDA Advisory Committee Membership has diverse professional education, Nominations—OMB Control Number training, and experience so that the 0910–NEW DEPARTMENT OF HEALTH AND committee will reflect a balanced HUMAN SERVICES FDA chooses to select advisory composition of sufficient scientific committee members through a expertise to handle the problems that Food and Drug Administration nomination process. (Appendix A to come before it (21 CFR 14.80(b)(1)(i)). In Subpart C of 41 CFR 102–3, the Federal the case of Industry and Consumer [Docket No. FDA–2017–N–0366] Advisory Committee Management Final Representatives, information is Rule notes that the Federal Advisory collected to assess the candidate’s Agency Information Collection Committee Act (FACA, 5 U.S.C. App. 2) ability to represent all interested Activities; Submission for Office of does not specify the manner in which persons within the class which the Management and Budget Review; advisory committee members and staff member is selected to represent (21 CFR Comment Request; Advisory must be appointed.) A person can self- 14.86). Committee Nomination Applications nominate or be nominated by another Each nominee should be sure to individual. In order to identify and review the Agency Web site for AGENCY: Food and Drug Administration, select qualified individuals to serve on information on: HHS. its advisory committees, FDA has • Vacancies, qualifications, and ACTION: Notice. established an online portal, the FDA experience for more details concerning Advisory Committee Membership vacancies on each committee and the SUMMARY: The Food and Drug Application, to accept nominations of qualifications and experience common Administration (FDA or we) is potential advisory committee members. for nominees. Vacancies are updated announcing that a proposed collection The FDA Advisory Committee periodically; therefore, one or more of information has been submitted to the Membership Application accepts vacancies listed may be in the Office of Management and Budget nominations for Academician/ nomination process or a final (OMB) for review and clearance under Practitioner, Consumer Representative, appointment may have been made. the Paperwork Reduction Act of 1995 and Industry Representative • Potential conflicts of interest such (the PRA). membership types. Nominees who are as financial holdings, employment, and DATES: Fax written comments on the nominated as scientific members should research grants and/or contracts in order collection of information by June 22, be technically qualified experts in the to permit evaluation of possible sources 2017. field (e.g., clinical medicine, of conflict of interest. engineering, biological and physical Also, FDA asks that prospective ADDRESSES: To ensure that comments on sciences, biostatistics, food sciences) nominees inform us of how they heard the information collection are received, and have experience interpreting about the FDA Advisory Committees OMB recommends that written complex data. Candidates must be able (e.g., attendance at a professional comments be faxed to the Office of to analyze detailed scientific data and meeting, an article in a publication, our Information and Regulatory Affairs, understand its public health Web site, while speaking with a friend OMB, Attn: FDA Desk Officer, FAX: significance. The nomination process or colleague). 202–395–7285, or emailed to oira_ has recently been made electronic and To further the Agency’s goals of submission@omb.eop.gov. All is available at http:// promoting transparency regarding the comments should be identified with the accessdata.test.fda.gov/scripts/ advisory committee process, FDA will OMB control number, 0910–NEW, and FACTRSPortal/FACTRS/index.cfm. To also require that nominees to serve on title, ‘‘FDA Advisory Committee submit a nomination, nominators or advisory committees submit a consent Membership Nominations.’’ Also prospective nominees should upload form authorizing FDA to publicly post include the FDA docket number found the following documents in PDF format to FDA’s Web site the CV submitted as in brackets in the heading of this (see 21 CFR 14.82(c)): (1) Curriculum part of their nomination materials if the document. vitae (CV); (2) a written confirmation nominee is selected to serve on an sradovich on DSK3GMQ082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: that the nominee(s) is (are) aware of the advisory committee. In the past, FDA Jonnalynn Capezzuto, Office of nomination (unless self-nominated); and has generally posted the CVs of FDA Operations, Food and Drug (3) letters of recommendation are also advisory committee members publicly Administration, Three White Flint suggested. For Consumer Representative on http://www.fda.gov/ North, 10A63, 11601 Landsdown St., nominations, a cover letter that lists AdvisoryCommittees/ after reviewing North Bethesda, MD 20852, 301–796– consumer or community organizations the CVs and redacting information that 3794, PRAStaff@fda.hhs.gov. for which the candidate can appeared to be confidential. However, VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1

23584 Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices in furtherance of FDA’s goal of ensuring consent form requires that the nominee day notice requesting public comment transparency regarding the affirm that the CV does not include any on the proposed collection of qualifications of individuals selected to confidential information, including information. One comment was received serve on FDA advisory committees, and information pertaining to third parties in support of the information collection in recognition that individual advisory that the nominee is not permitted to and recommended no changes to the committee members are best situated to disclose. A nominee will be required to Agency’s burden estimate. On our own evaluate the confidentiality of submit a signed consent form as a part initiative, however, we have revised the information contained in their CVs, of the nomination package in order for estimate provided in our 60 day notice including any considerations raised by the nomination to be considered to reflect an increase of 23.5 burden their relationships and agreements with complete. hours and 94 responses. While we All nominations for new advisory third parties, FDA will now be requiring believe our original burden estimate committee members will be required to that all CVs submitted as part of the be submitted through FDA’s Web site at accurately reflects the time burden nomination process for positions on http://accessdata.test.fda.gov/scripts/ associated with providing the specific FDA advisory committees be FACTRSPortal/FACTRS/index.cfm, or data elements, but we have increased accompanied by a written consent form any successor system, and the the number of respondents to the stating that, if the nominee is accepted submission will be required to be collection to include Industry as a member of an FDA advisory accompanied by the consent form, on or Representative members of FDA committee, the nominee consents to the after the date of OMB approval for this advisory committees. publication of the nominee’s CV to information collection. We therefore estimate the burden of FDA’s Web site, without FDA removing In the Federal Register of February 6, the information collection as follows: or redacting any information. The 2017 (82 FR 9383), we published a 60- TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average 21 CFR part 14; subpart E—members of advisory Number of Total annual responses per burden per Total hours committees respondents responses respondent response Advisory Committee Membership Nominations ................... 583 1 583 0.25 145.75 (15 minutes) Representative Member Submission of Updated Informa- tion .................................................................................... 64 1 64 0.25 16.0 (15 minutes) Total .............................................................................. ........................ ........................ 647 ........................ 161.75 1 There are no capital or operating and maintenance costs associated with the information collection. Based on a review of data, we members, mostly Industry DEPARTMENT OF HEALTH AND received 638 nominations for representatives. While some positions HUMAN SERVICES membership to FDA advisory are vacant, we anticipate the positions committees in Fiscal Year (FY) 2011; we will be filled during the year. The Food and Drug Administration received 603 nominations in FY 2012; request for the updated CV and consent we received 622 in FY 2013; we [Docket No. FDA–2010–N–0588] will be made through email received 545 in FY 2014; and we communications by the Designated Agency Information Collection received 505 nominations in FY 2015. Federal Officer of the committee. We Activities; Proposed Collection; By averaging the number of nominations anticipate that the burden to the Comment Request; Exceptions or received annually over the past 5 years, respondent will be the same as that for Alternatives to Labeling Requirements we estimate there are approximately 583 new nominations. We estimate each for Products Held by the Strategic respondents to the information response will require 15 minutes (0.25) National Stockpile collection. We estimate it takes for a total of 16 annual hours. respondents 15 minutes to complete an AGENCY: Food and Drug Administration, initial nomination, where Dated: May 18, 2017. HHS. accompanying documentation is already Anna K. Abram, ACTION: Notice. available or has been prepared in Deputy Commissioner for Policy, Planning, advance by respondents. Multiplying 15 Legislation, and Analysis. SUMMARY: The Food and Drug minutes (0.25) by the number of [FR Doc. 2017–10531 Filed 5–22–17; 8:45 am] Administration (FDA or Agency) is respondents to the information announcing an opportunity for public BILLING CODE 4164–01–P collection (583) equals 145.75 annual comment on the proposed collection of burden hours. certain information by the Agency. We have also included a burden Under the Paperwork Reduction Act of estimate for members who currently 1995 (PRA), Federal Agencies are sradovich on DSK3GMQ082PROD with NOTICES serve on FDA advisory committees who required to publish notice in the are not Special Government and Regular Federal Register concerning each Government Employees and who must proposed collection of information, submit an updated CV and an executed/ including each proposed extension of an completed consent form annually. existing collection of information, and Currently there are 64 authorized to allow 60 days for public comment in positions for these Representative response to the notice. This notice VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1


Document Created: 2017-05-23 02:14:32
Document Modified: 2017-05-23 02:14:32
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by June 22, 2017.
ContactJonnalynn 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]
FR Citation82 FR 23583 
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