Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates To Serve on the Food and Drug Administration's Advisory Committees, 9383-9385 [2017-02412]

Download as PDF Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices advisory committee member’s CV is submitted to FDA. All information contained in the CV submission for individuals who are selected for or currently serving on an FDA advisory committee will be available for public posting. Specifically, for nominees for positions on an FDA advisory committee, the required consent will state as follows: ACTION: For existing advisory committee members who submit updated CVs, the required consent will state as follows: I consent to publication of my curriculum vitae (CV), and any subsequent updates to my CV that I provide FDA, on FDA’s Web site, without removing or redacting any information. My CV does not include any confidential information, including information pertaining to third parties that I am not permitted to disclose. III. Date of Implementation All nominations for new advisory committee members will be required to be submitted through FDA’s Web site at https://www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm, or any successor system, and the submission will be required to be accompanied by the required consent form, on or after the date of OMB approval for this information collection. All updated CVs for existing advisory committee members will be required to be submitted to FDA along with the required consent form after March 8, 2017. Dated: February 1, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–02411 Filed 2–3–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSK3GMQ082PROD with NOTICES [Docket No. FDA–2017–N–0366] Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates To Serve on the Food and Drug Administration’s Advisory Committees Food and Drug Administration, HHS. VerDate Sep<11>2014 16:03 Feb 03, 2017 Jkt 241001 The Food and Drug Administration (FDA or Agency) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Agency’s process for collecting nominations of candidates to serve on FDA’s advisory committees. DATES: Submit either electronic or written comments on the collection of information by April 7, 2017. ADDRESSES: You may submit comments as follows: SUMMARY: If I am selected to serve on an advisory committee, I consent to publication of my curriculum vitae (CV), and any subsequent updates to my CV that I provide FDA, on FDA’s Web site, without removing or redacting any information. My CV does not include any confidential information, including information pertaining to third parties that I am not permitted to disclose. AGENCY: Notice. 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 9383 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 ‘‘Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates to Serve on FDA’s Advisory Committees.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food E:\FR\FM\06FEN1.SGM 06FEN1 9384 Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. Under the PRA (44 U.S.C. 3501–3520), 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. SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES Process for Collecting Nominations of Candidates to Serve on FDA’s Advisory Committees—OMB Control Number 0910—NEW FDA chooses to select advisory committee members through a nomination process.1 A person can selfnominate 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 1 Key point and principle I. of Appendix A to Subpart C of 41 CFR 102–3, the Federal Advisory Committee Management Final Rule notes that the Federal Advisory Committee Act does not specify the manner in which advisory committee members and staff must be appointed. VerDate Sep<11>2014 16:03 Feb 03, 2017 Jkt 241001 Application, to accept nominations of potential advisory committee members. The FDA Advisory Committee Membership Application accepts applications 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 https:// accessdata.test.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm. To submit an application, prospective nominees should upload the following documents in PDF format: 2 (1) Curriculum vitae (CV); (2) a written confirmation that the nominee(s) is aware of the nomination (unless selfnominated); and (3) letters of recommendation are also suggested. For Consumer Representative applications, 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 2 21 PO 00000 CFR 14.82(c). Frm 00015 Fmt 4703 Sfmt 4703 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 generally has posted the CVs of FDA advisory committee members publicly on https://www.fda.gov/ AdvisoryCommittees/after reviewing the CVs and redacting information that appeared to be confidential. However, 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 individual consents to the publication of the individual’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 https://www.accessdata.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. An estimate of the burden of this collection is provided in table 1. FDA E:\FR\FM\06FEN1.SGM 06FEN1 9385 Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices expects that 138.25 burden hours will be expended annually by respondents to the collection of information. FDA estimates that 553 respondents will each submit 1 application for a total of 553 annual responses. We estimate each response will require an average of 0.25 hours (15 minutes) for a total of 138.25 annual hours. Our estimate of 553 respondents is based on averaging the number of nomination submissions we have received over the past 5 fiscal years. In fiscal year (FY) 2011 we received 638 submissions; FY 2012, 603 submissions; FY 2013, 622 submissions; FY 2014, 545 submissions; and FY 2015, 357 submissions. We believe that each submission will require 15 minutes based on our experience with the submission portal. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Part 14; Subpart E—Members of Advisory Committees Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Advisory Committee Membership Applications ............. 553 1 553 0.25 (15 minutes) 138.25 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 1, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–02412 Filed 2–3–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings sradovich on DSK3GMQ082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–14– 355 Panel: Pregnancy in Women With Disabilities (R01). Date: February 27, 2017. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Martha L. Hare, RN, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3154, MSC 7770, Bethesda, MD 20892, (301) 451– 8504, harem@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Pain and Chemosensory Mechanisms. Date: February 28–March 1, 2017. VerDate Sep<11>2014 16:03 Feb 03, 2017 Jkt 241001 Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: John Bishop, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7844, Bethesda, MD 20892, (301) 408– 9664, bishopj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Synthetic Psychoactive Drugs and Strategic Approaches to Counteract their Deleterious Effects. Date: February 28, 2017. Time: 2:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214 MSC 7814, Bethesda, MD 20892–7814, 301– 435–1787, borzanj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR16–095: Biopsychosocial Mechanisms in the Management of Chronic Conditions. Date: February 28–March 1, 2017. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Unja Hayes, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301– 435–1037, unja.hayes@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR16–212: Cognitive Neuroscience and Assessment of Cancer Treatment-Related Cognitive Impairment. Date: March 1, 2017. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kristin Kramer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5205, MSC 7846, Bethesda, MD 20892, (301) 437– 0911, kramerkm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neural Trauma and Stroke. Date: March 1, 2017. Time: 1:00 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Alexei Kondratyev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301–435– 1785, kondratyevad@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: January 30, 2017. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–02385 Filed 2–3–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the E:\FR\FM\06FEN1.SGM 06FEN1

Agencies

[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Pages 9383-9385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02412]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Collection of Nominations for Candidates To Serve on 
the Food and Drug Administration's Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) 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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the Agency's process for collecting nominations of 
candidates to serve on FDA's advisory committees.

DATES: Submit either electronic or written comments on the collection 
of information by April 7, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Agency Information Collection Activities: 
Proposed Collection; Comment Request; Collection of Nominations for 
Candidates to Serve on FDA's Advisory Committees.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food

[[Page 9384]]

and Drug Administration, Three White Flint North 10A63, 11601 Landsdown 
St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Process for Collecting Nominations of Candidates to Serve on FDA's 
Advisory Committees--OMB Control Number 0910--NEW

    FDA chooses to select advisory committee members through a 
nomination process.\1\ 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.
---------------------------------------------------------------------------

    \1\ Key point and principle I. of Appendix A to Subpart C of 41 
CFR 102-3, the Federal Advisory Committee Management Final Rule 
notes that the Federal Advisory Committee Act does not specify the 
manner in which advisory committee members and staff must be 
appointed.
---------------------------------------------------------------------------

    The FDA Advisory Committee Membership Application accepts 
applications 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 https://accessdata.test.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. To submit an application, prospective nominees should upload 
the following documents in PDF format: \2\ (1) Curriculum vitae (CV); 
(2) a written confirmation that the nominee(s) is aware of the 
nomination (unless self-nominated); and (3) letters of recommendation 
are also suggested.
---------------------------------------------------------------------------

    \2\ 21 CFR 14.82(c).
---------------------------------------------------------------------------

    For Consumer Representative applications, 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 generally has posted the CVs of 
FDA advisory committee members publicly on https://www.fda.gov/AdvisoryCommittees/after reviewing the CVs and redacting information 
that appeared to be confidential. However, 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 individual 
consents to the publication of the individual'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 https://www.accessdata.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.
    An estimate of the burden of this collection is provided in table 
1. FDA

[[Page 9385]]

expects that 138.25 burden hours will be expended annually by 
respondents to the collection of information. FDA estimates that 553 
respondents will each submit 1 application for a total of 553 annual 
responses. We estimate each response will require an average of 0.25 
hours (15 minutes) for a total of 138.25 annual hours.
    Our estimate of 553 respondents is based on averaging the number of 
nomination submissions we have received over the past 5 fiscal years. 
In fiscal year (FY) 2011 we received 638 submissions; FY 2012, 603 
submissions; FY 2013, 622 submissions; FY 2014, 545 submissions; and FY 
2015, 357 submissions. We believe that each submission will require 15 
minutes based on our experience with the submission portal.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Advisory Committee Membership Applications..             553                1              553   0.25 (15 minutes).....................          138.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 1, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02412 Filed 2-3-17; 8:45 am]
 BILLING CODE 4164-01-P

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