Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 25277 

MD 20993, 301–796–8695, email: 

Shivana.Srivastava@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

Pediatric Advisory Committee: 

I. General Description of the Committee 

Duties 

The Committee reviews, 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 in 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 

(the 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 Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, a current resume, and the 

name of the committee of interest 

should be sent to the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). 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 

individuals on its advisory committees 

regardless of their gender identification, 

religious affiliation, racial and ethnic 

identification, or disability status and 

therefore encourages nominations of 

appropriately qualified candidates from 

all 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. 

Dated: April 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09071 Filed 4–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0620] 

Advisory Committee; Pharmaceutical 

Science and Clinical Pharmacology 

Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Pharmaceutical Science 

and Clinical Pharmacology Advisory 

Committee by the Commissioner of 

Food and Drugs (the Commissioner). 

The Commissioner has determined that 

it is in the public interest to renew the 

Pharmaceutical Science and Clinical 

Pharmacology Advisory Committee for 

an additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the January 22, 2024, 

expiration date. 

DATES: Authority for the Pharmaceutical 

Science and Clinical Pharmacology 

Advisory Committee will expire on 

January 22, 2024, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Rhea Bhatt, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993, 301–796– 

9001, email: ACPS-CP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Pharmaceutical Science 

and Clinical Pharmacology Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

scientific, clinical and technical issues 

related to the safety and effectiveness of 

drug products for use in the treatment 

of a broad spectrum of human diseases, 

the quality characteristics which such 


jspears on DSK121TN23PROD with NOTICES1
25278 Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 

drugs purport or are represented to 

have, and as required, any other product 

for which FDA has regulatory 

responsibility, and make appropriate 

recommendations to the Commissioner. 

The Committee may also review Agency 

sponsored intramural and extramural 

biomedical research programs in 

support of FDA’s drug regulatory 

responsibilities and its critical path 

initiatives related to improving the 

efficacy and safety of drugs and 

improving the efficiency of drug 

development. 

The Committee shall consist of a core 

of 14 voting members including two 

Chairpersons. Members and 

Chairpersons are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of pharmaceutical sciences 

(pharmaceutical manufacturing, 

bioequivalence research, laboratory 

analytical techniques, pharmaceutical 

chemistry, physiochemistry, 

biochemistry, molecular biology, 

immunology, microbiology) and clinical 

pharmacology (dose-response, 

pharmacokinetics-pharmacodynamics, 

modeling and simulation, 

pharmacogenomics, clinical trial design, 

pediatrics and special populations and 

innovative methods in drug 

development), biostatistics, related 

biomedical and pharmacological 

specialties, current good manufacturing 

practices, and quality systems 

implementation. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Non-Federal members of 

this committee will serve as Special 

Government Employees, representatives 

or Ex-Officio members. Federal 

members will serve as Regular 

Government Employees or Ex-Officios. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include up to three non-voting 

representative members who are 

identified with industry interests. There 

may also be an alternate industry 

representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

human-drug-advisory-committees/ 

pharmaceutical-science-and-clinicalpharmacology-advisory-committee or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: April 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09076 Filed 4–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2001–D–0067] 

Providing Submissions in Electronic 

Format—Postmarketing Safety 

Reports; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Providing Submissions in Electronic 

Format—Postmarketing Safety Reports.’’ 

This guidance provides general 

information pertaining to electronic 

submission of postmarketing safety 

reports (individual case safety reports 

(ICSRs), attachments to ICSRs (ICSR 

attachments), and other postmarketing 

safety reports) for certain human drugs, 

biological products, and combination 

products. This guidance finalizes the 

revised draft guidance entitled 

‘‘Providing Submissions in Electronic 

Format—Postmarketing Safety Reports,’’ 

issued in June 2014. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 28, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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): 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– 

2001–D–0067 for ‘‘Providing 

Submissions in Electronic Format— 

Postmarketing Safety Reports.’’ 

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 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 


jspears on DSK121TN23PROD with NOTICES1