Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50883 

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. 

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: marieann.brill@

fda.hhs.gov. 

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 re ́sume ́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 re ́sume ́ 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. 


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50884 Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6129] 

Assessment of Food and Drug 

Administration Hiring and Retention; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Assessment of FDA 

Hiring and Retention’’. The purpose of 

the public meeting is to share high-level 

findings from a recently completed 

diagnostic assessment of FDA’s hiring 

process conducted by a qualified, 

independent contractor with expertise 

in assessing human resources operations 

and transformation. The purpose also is 

to outline a set of near-term actions FDA 

will or can take to improve the hiring 

process, provide an update on FDA’s 

progress toward Prescription Drug User 

Fee Act (PDUFA) and Biosimilar User 

Fee Act (BsUFA) user fee hiring and 

retention commitments, and solicit 

input on actions FDA is taking and any 

further recommendations or priorities 

FDA should pursue with regard to the 

hiring process. 

DATES: The public meeting will be held 

on November 30, 2017, from 9 a.m. to 

12 noon. Submit either electronic or 

written comments on this public 

workshop by January 15, 2018. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at the FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Section A, Silver Spring, MD 

20993. Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

A summary report of evaluation 

findings related to the hiring process, 

conducted by an independent third 

party contractor, will be published in 

the docket by November 15, 2017, and 

will be titled ‘‘Initial Assessment of 

FDA Hiring and Retention.’’ 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before January 15, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of January 15, 2018. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is 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–6129 for ‘‘Assessment of FDA 

Hiring and Retention; Public Meeting; 

Request for Comments.’’ 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. 

• 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Brounstein, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 1312, Silver Spring, 


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