82_FR_51094 82 FR 50883 - Request for Nominations on the Pediatric Advisory Committee

82 FR 50883 - Request for Nominations on the Pediatric Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 211 (November 2, 2017)

Page Range50883-50884
FR Document2017-23903

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

Federal Register, Volume 82 Issue 211 (Thursday, November 2, 2017) 
[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Pages 50883-50884]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23903]



[[Page 50883]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6266]


Request for Nominations on the Pediatric Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
industry organizations interested in participating in the selection of 
a nonvoting industry representative to serve on the Pediatric Advisory 
Committee for the Office of the Commissioner notify FDA in writing. FDA 
is also requesting nominations for a nonvoting industry 
representative(s) to serve on the Pediatric Advisory Committee. A 
nominee may either be self-nominated or nominated by an organization to 
serve as a nonvoting industry representative. Nominations will be 
accepted for current vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by December 
4, 2017 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by December 4, 2017. Nominations received on or before 
December 4, 2017 will be given first consideration for membership on 
the Pediatric Advisory Committee. Nominations received after December 
4, 2017 will be considered for nomination to the committee as later 
vacancies occur.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nomination should be sent to Marieann Brill 
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting 
industry representatives should be sent electronically by logging into 
the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee 
Oversight and Management Staff, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. 
Information about becoming a member on an FDA advisory committee can 
also be obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
nonvoting industry representative the primary contact is: Marieann 
Brill, Office of the Commissioner, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-
402-3838, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for nonvoting 
industry representative(s) on the Pediatric Advisory Committee:

I. General Description of the Committee Duties

    The Committee reviews and evaluates and makes recommendations to 
the Commissioner of Food and Drugs (the Commissioner) regarding (1) 
pediatric research conducted under sections 351, 409I, and 499 of the 
Public Health Service Act (42 U.S.C. 262, 284m, and 290b) and sections 
501, 502, 505, 505A, 505B, 510(k), 515, and 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351, 352, 355, 355a, 355c, 360(k), 
360e, and 360j(m)); (2) identification of research priorities related 
to pediatric therapeutics (including drugs and biological products) and 
medical devices for pediatric populations and the need for additional 
diagnostics and treatments of specific pediatric diseases or 
conditions; (3) the ethics, design, and analysis of clinical trials 
related to pediatric therapeutics (including drugs and biological 
products) and medical devices; (4) pediatric labeling disputes as 
specified in Public Law 107-109, Public Law 110-85, and Public Law 112-
144; (5) pediatric labeling changes as specified in Public Law 107-109, 
Public Law 110-85, and Public Law 112-144; (6) adverse event reports 
for drugs studied under Public Law 107-109, Public Law 110-85, and 
Public Law 112-144; (7) any safety issues that may occur as specified 
Public Law 107-109, Public Law 110-85, and Public Law 112-144; (8) any 
other pediatric issue or pediatric labeling dispute involving FDA-
regulated products; (9) pediatric ethical issues including research 
involving children as subjects as specified in 21 CFR 50.54; and (10) 
any other matter involving pediatrics for which FDA has regulatory 
responsibility.
    The Committee also advises and makes recommendations to the 
Secretary of Health and Human Services (Secretary) (HHS) directly or to 
the Secretary through the Commissioner on research involving children 
as subjects that is conducted or supported by HHS as specified in 45 
CFR 46.407.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations, and a list of all nominees 
along with their current r[eacute]sum[eacute]s. The letter will also 
state that it is the responsibility of the interested organizations to 
confer with one another and to select a candidate, within 60 days after 
the receipt of the FDA letter, to serve as the nonvoting member to 
represent industry interests for the committee. The interested 
organizations are not bound by the list of nominees in selecting a 
candidate. However, if no individual is selected within 60 days, the 
Commissioner will select the nonvoting member to represent industry 
interests.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the advisory committee. Self-nominations 
are also accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed 
copy of the Acknowledgement and Consent form available at the FDA 
Advisory Nomination Portal (see ADDRESSES). Nominations must also 
specify the advisory committee for which the nominee is recommended. 
Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. FDA will forward all nominations to 
the organizations expressing interest in participating in the selection 
process for the committee. (Persons who nominate themselves as 
nonvoting industry representatives will not participate in the 
selection process.)
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.


[[Page 50884]]


    Dated: October 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23903 Filed 11-1-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50883 DEPARTMENT OF HEALTH AND Web site at https://www.fda.gov/ research involving children as subjects HUMAN SERVICES AdvisoryCommittees/default.htm. that is conducted or supported by HHS FOR FURTHER INFORMATION CONTACT: as specified in 45 CFR 46.407. Food and Drug Administration Regarding all nomination questions for II. Selection Procedure [Docket No. FDA–2017–N–6266] nonvoting industry representative the primary contact is: Marieann Brill, Any industry organization interested Request for Nominations on the Office of the Commissioner, Food and in participating in the selection of an Pediatric Advisory Committee Drug Administration, 10903 New appropriate nonvoting member to Hampshire Ave., Bldg. 32, Rm. 5154, represent industry interests should send AGENCY: Food and Drug Administration, Silver Spring, MD 20993, 240–402– a letter stating that interest to the FDA HHS. 3838, email: marieann.brill@ contact (see FOR FURTHER INFORMATION ACTION: Notice. fda.hhs.gov. CONTACT) within 30 days of publication SUPPLEMENTARY INFORMATION: FDA is of this document (see DATES). Within the SUMMARY: The Food and Drug subsequent 30 days, FDA will send a Administration (FDA) is requesting that requesting nominations for nonvoting industry representative(s) on the letter to each organization that has any industry organizations interested in expressed an interest, attaching a participating in the selection of a Pediatric Advisory Committee: complete list of all such organizations, nonvoting industry representative to I. General Description of the Committee and a list of all nominees along with serve on the Pediatric Advisory Duties their current résumés. The letter will Committee for the Office of the also state that it is the responsibility of Commissioner notify FDA in writing. The Committee reviews and evaluates and makes recommendations to the the interested organizations to confer FDA is also requesting nominations for with one another and to select a a nonvoting industry representative(s) to Commissioner of Food and Drugs (the Commissioner) regarding (1) pediatric candidate, within 60 days after the serve on the Pediatric Advisory receipt of the FDA letter, to serve as the Committee. A nominee may either be research conducted under sections 351, 409I, and 499 of the Public Health nonvoting member to represent industry self-nominated or nominated by an interests for the committee. The organization to serve as a nonvoting Service Act (42 U.S.C. 262, 284m, and 290b) and sections 501, 502, 505, 505A, interested organizations are not bound industry representative. Nominations by the list of nominees in selecting a will be accepted for current vacancies 505B, 510(k), 515, and 520(m) of the Federal Food, Drug, and Cosmetic Act candidate. However, if no individual is effective with this notice. selected within 60 days, the (21 U.S.C. 351, 352, 355, 355a, 355c, DATES: Any industry organization Commissioner will select the nonvoting 360(k), 360e, and 360j(m)); (2) interested in participating in the member to represent industry interests. identification of research priorities selection of an appropriate nonvoting related to pediatric therapeutics III. Nomination Procedures member to represent industry interests (including drugs and biological must send a letter stating that interest to Any interested person may nominate products) and medical devices for FDA by December 4, 2017 (see sections one or more qualified individuals for pediatric populations and the need for I and II of this document for further membership on the advisory committee. additional diagnostics and treatments of details). Concurrently, nomination Self-nominations are also accepted. specific pediatric diseases or conditions; materials for prospective candidates Nominations must include a current, (3) the ethics, design, and analysis of should be sent to FDA by December 4, complete résumé or curriculum vitae for clinical trials related to pediatric 2017. Nominations received on or before each nominee and a signed copy of the therapeutics (including drugs and December 4, 2017 will be given first Acknowledgement and Consent form biological products) and medical consideration for membership on the available at the FDA Advisory devices; (4) pediatric labeling disputes Pediatric Advisory Committee. Nomination Portal (see ADDRESSES). as specified in Public Law 107–109, Nominations received after December 4, Nominations must also specify the Public Law 110–85, and Public Law 2017 will be considered for nomination advisory committee for which the 112–144; (5) pediatric labeling changes to the committee as later vacancies nominee is recommended. Nominations as specified in Public Law 107–109, occur. must also acknowledge that the Public Law 110–85, and Public Law ADDRESSES: All statements of interest 112–144; (6) adverse event reports for nominee is aware of the nomination from industry organizations interested drugs studied under Public Law 107– unless self-nominated. FDA will in participating in the selection process 109, Public Law 110–85, and Public forward all nominations to the of nonvoting industry representative Law 112–144; (7) any safety issues that organizations expressing interest in nomination should be sent to Marieann may occur as specified Public Law 107– participating in the selection process for Brill (see FOR FURTHER INFORMATION 109, Public Law 110–85, and Public the committee. (Persons who nominate CONTACT). All nominations for Law 112–144; (8) any other pediatric themselves as nonvoting industry nonvoting industry representatives issue or pediatric labeling dispute representatives will not participate in should be sent electronically by logging involving FDA-regulated products; (9) the selection process.) into the FDA Advisory Nomination pediatric ethical issues including FDA seeks to include the views of Portal: https://www.accessdata.fda.gov/ research involving children as subjects women and men, members of all racial and ethnic groups, and individuals with asabaliauskas on DSKBBXCHB2PROD with NOTICES scripts/FACTRSPortal/FACTRS/ as specified in 21 CFR 50.54; and (10) index.cfm or by mail to Advisory any other matter involving pediatrics for and without disabilities on its advisory Committee Oversight and Management which FDA has regulatory committees and, therefore, encourages Staff, Food and Drug Administration, responsibility. nominations of appropriately qualified 10903 New Hampshire Ave., Bldg. 32, The Committee also advises and candidates from these groups. Rm. 5103, Silver Spring, MD 20993– makes recommendations to the This notice is issued under the 0002. Information about becoming a Secretary of Health and Human Services Federal Advisory Committee Act (5 member on an FDA advisory committee (Secretary) (HHS) directly or to the U.S.C. app. 2) and 21 CFR part 14, can also be obtained by visiting FDA’s Secretary through the Commissioner on relating to advisory committees. VerDate Sep<11>2014 22:28 Nov 01, 2017 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\02NON1.SGM 02NON1

50884 Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices Dated: October 30, 2017. A summary report of evaluation identified, as confidential, if submitted Anna K. Abram, findings related to the hiring process, as detailed in ‘‘Instructions.’’ Deputy Commissioner for Policy, Planning, conducted by an independent third Instructions: All submissions received Legislation, and Analysis. party contractor, will be published in must include the Docket No. FDA– [FR Doc. 2017–23903 Filed 11–1–17; 8:45 am] the docket by November 15, 2017, and 2017–N–6129 for ‘‘Assessment of FDA BILLING CODE 4164–01–P will be titled ‘‘Initial Assessment of Hiring and Retention; Public Meeting; FDA Hiring and Retention.’’ Request for Comments.’’ Received You may submit comments as comments, those filed in a timely DEPARTMENT OF HEALTH AND follows. Please note that late, untimely manner (see ADDRESSES), will be placed HUMAN SERVICES filed comments will not be considered. in the docket and, except for those Electronic comments must be submitted submitted as ‘‘Confidential Food and Drug Administration on or before January 15, 2018. The Submissions,’’ publicly viewable at [Docket No. FDA–2017–N–6129] https://www.regulations.gov electronic https://www.regulations.gov or at the filing system will accept comments Dockets Management Staff between 9 Assessment of Food and Drug until midnight Eastern Time at the end a.m. and 4 p.m., Monday through Administration Hiring and Retention; of January 15, 2018. Comments received Friday. Public Meeting; Request for Comments by mail/hand delivery/courier (for • Confidential Submissions—To written/paper submissions) will be submit a comment with confidential AGENCY: Food and Drug Administration, considered timely if they are HHS. information that you do not wish to be postmarked or the delivery service made publicly available, submit your ACTION: Notice of public meeting; acceptance receipt is on or before that comments only as a written/paper request for comments. date. submission. You should submit two SUMMARY: The Food and Drug Electronic Submissions copies total. One copy will include the Administration (FDA, the Agency, or information you claim to be confidential Submit electronic comments in the we) is announcing the following public with a heading or cover note that states following way: meeting entitled ‘‘Assessment of FDA ‘‘THIS DOCUMENT CONTAINS • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The Hiring and Retention’’. The purpose of https://www.regulations.gov. Follow the the public meeting is to share high-level Agency will review this copy, including instructions for submitting comments. the claimed confidential information, in findings from a recently completed Comments submitted electronically, diagnostic assessment of FDA’s hiring its consideration of comments. The including attachments, to https:// second copy, which will have the process conducted by a qualified, www.regulations.gov will be posted to independent contractor with expertise claimed confidential information the docket unchanged. Because your redacted/blacked out, will be available in assessing human resources operations comment will be made public, you are and transformation. The purpose also is for public viewing and posted on solely responsible for ensuring that your https://www.regulations.gov. Submit to outline a set of near-term actions FDA comment does not include any will or can take to improve the hiring both copies to the Dockets Management confidential information that you or a Staff. If you do not wish your name and process, provide an update on FDA’s third party may not wish to be posted, progress toward Prescription Drug User contact information to be made publicly such as medical information, your or available, you can provide this Fee Act (PDUFA) and Biosimilar User anyone else’s Social Security number, or Fee Act (BsUFA) user fee hiring and information on the cover sheet and not confidential business information, such in the body of your comments and you retention commitments, and solicit as a manufacturing process. Please note input on actions FDA is taking and any must identify this information as that if you include your name, contact ‘‘confidential.’’ Any information marked further recommendations or priorities information, or other information that FDA should pursue with regard to the as ‘‘confidential’’ will not be disclosed identifies you in the body of your except in accordance with 21 CFR 10.20 hiring process. comments, that information will be and other applicable disclosure law. For DATES: The public meeting will be held posted on https://www.regulations.gov. more information about FDA’s posting on November 30, 2017, from 9 a.m. to • If you want to submit a comment of comments to public dockets, see 80 12 noon. Submit either electronic or with confidential information that you FR 56469, September 18, 2015, or access written comments on this public do not wish to be made available to the the information at: https://www.gpo.gov/ workshop by January 15, 2018. See the public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- SUPPLEMENTARY INFORMATION section for written/paper submission and in the 23389.pdf. registration date and information. manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to ADDRESSES: The public meeting will be read background documents or the held at the FDA’s White Oak Campus, Written/Paper Submissions electronic and written/paper comments 10903 New Hampshire Ave., Bldg. 31 Submit written/paper submissions as received, go to https:// Conference Center, the Great Room (Rm. follows: www.regulations.gov and insert the 1503), Section A, Silver Spring, MD • Mail/Hand delivery/Courier (for docket number, found in brackets in the 20993. Entrance for the public meeting written/paper submissions): Dockets heading of this document, into the asabaliauskas on DSKBBXCHB2PROD with NOTICES participants (non-FDA employees) is Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts through Building 1 where routine Drug Administration, 5630 Fishers and/or go to the Dockets Management security check procedures will be Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, performed. For parking and security • For written/paper comments Rockville, MD 20852. information, please refer to https:// www.fda.gov/AboutFDA/ submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: WorkingatFDA/BuildingsandFacilities/ Staff, FDA will post your comment, as Daniel Brounstein, Food and Drug WhiteOakCampusInformation/ well as any attachments, except for Administration, 10903 New Hampshire ucm241740.htm. information submitted, marked and Ave., Bldg. 1, Rm. 1312, Silver Spring, VerDate Sep<11>2014 22:28 Nov 01, 2017 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\02NON1.SGM 02NON1


Document Created: 2017-11-02 02:41:31
Document Modified: 2017-11-02 02:41:31
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.
DatesAny industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by December 4, 2017 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by December 4, 2017. Nominations received on or before December 4, 2017 will be given first consideration for membership on the Pediatric Advisory Committee. Nominations received after December 4, 2017 will be considered for nomination to the committee as later vacancies occur.
ContactRegarding all nomination questions for nonvoting industry representative the primary contact is: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240- 402-3838, email: [email protected]
FR Citation82 FR 50883 
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