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 


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Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 25279 

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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

For information concerning human 

drug products: Suranjan De, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4307, 

Silver Spring, MD 20993–0002, 240– 

402–0498. 

For information concerning human 

biological products: Stephen Ripley, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a 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 (ICSRs, ICSR attachments, and 

other postmarketing safety reports) 

under the following provisions: 

• 21 CFR 314.80 and 314.98 

(regarding products with approved new 

drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs), respectively, including 

combination products or drug 

constituent parts with approved NDAs 

or ANDAs) 

• 21 CFR 600.80 (regarding products 

with approved biologics license 

applications (BLAs), including 

combination products or biological 

product constituent parts with approved 

BLAs) 

• 21 CFR part 4, subpart B (requiring 

additional reports for combination 

products with approved NDAs, ANDAs, 

or BLAs) 

• 21 CFR 310.305 (regarding 

prescription drug products marketed for 

human use without approved NDAs or 

ANDAs, including prescription drug 

products that are compounded by 

facilities registered as outsourcing 

facilities under section 503B of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 353b)) 

• 21 CFR 329.100 and section 760 of 

the FD&C Act (21 U.S.C. 379aa) 

(regarding nonprescription drug 

products marketed for human use 

without approved NDAs or ANDAs) 

This guidance does not apply to the 

following: Vaccines, human cells, 

tissues, and cellular tissue-based 

products regulated under section 361 of 

the Public Health Service Act (42 U.S.C. 

264), whole blood or blood components, 

combination products with a drug or 

biological product constituent part 

marketed under a device application, or 

lot distribution reports. 

On June 10, 2014, FDA published a 

final rule (79 FR 33072) to amend its 

postmarketing safety reporting 

regulations for human drug and 

biological products to require that 

persons subject to mandatory reporting 

requirements submit safety reports in an 

electronic format that the Agency can 

process, review, and archive. Elsewhere 

in the June 10, 2014, Federal Register 

(79 FR 33220), FDA announced the 

availability of a revised draft guidance 

entitled ‘‘Providing Submissions in 

Electronic Format—Postmarketing 

Safety Reports,’’ which revised and 

replaced the draft guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Postmarketing Individual Case Safety 

Reports,’’ issued on June 12, 2008 (73 

FR 33436). The guidance announced in 

this current notice finalizes the June 10, 

2014, revised draft guidance of the same 

title. The Agency considered comments 

on the draft guidance while finalizing 

the guidance. Generally, we revised the 

draft guidance to update and clarify 

topics, such as: (1) Options for 

transmitting reports in electronic 

format; (2) the notification that 

submitters will receive when FDA has 

received the electronic postmarketing 

safety report; (3) requesting temporary 

waivers from the electronic submission 

requirement; and (4) information on the 

receipt date of electronic submissions in 

the case of submission failure. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Providing 

Submissions in Electronic Format— 

Postmarketing Safety Reports.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 

pertaining to postmarketing reporting of 

adverse drug experiences, including 

periodic and followup reports, have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 207 

pertaining to registration of producers of 

drugs and listing of drugs in commercial 

distribution have been approved under 

OMB control number 0910–0045. The 

collections of information in 21 CFR 

parts 310, 314, and 600 pertaining to 

postmarketing reporting of adverse drug 

experiences for drugs subject to an NDA 

have been approved under OMB control 

number 0910–0291 (MedWatch Forms 

FDA 3500, 3500A, and 3500B). The 

collections of information in 21 CFR 

parts 310 and 314 pertaining to: (1) 

Postmarketing reporting of adverse drug 

experiences for drugs without approved 


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25280 Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 

NDAs and the collections of information 

and (2) the submissions required by 

section 760 of the FD&C Act for 

nonprescription human drug products 

marketed without an approved 

application have been approved under 

OMB control number 0910–0230. The 

collections of information in 21 CFR 

part 600 for biological drug products 

have been approved under OMB control 

number 0910–0308. The collections of 

information pertaining to the electronic 

submission of adverse event reports in 

21 CFR parts 310, 314, and 329 have 

been approved under OMB control 

number 0910–0645. The collections of 

information pertaining to submissions 

required for outsourcing facilities under 

section 503B of the FD&C Act have been 

approved under OMB control number 

0910–0800. The collections of 

information in 21 CFR part 4 pertaining 

to postmarketing safety information 

sharing by constituent part applicants 

for combination products have been 

approved under OMB control number 

0910–0834. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: April 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09065 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–2019–N–0305] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Products 

Subject to the Federal Food, Drug, and 

Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, 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, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on ‘‘Tobacco 

Products Subject to the Federal Food, 

Drug, and Cosmetic Act.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 27, 2022. 

ADDRESSES: 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 June 27, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 27, 2022. 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– 

2019–N–0305 for ‘‘Tobacco Products 

Subject to the Federal Food, Drug, and 

Cosmetic Act.’’ 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, 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 

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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jonnalynn Capezzuto, Office of 

Operations, Food and Drug 


jspears on DSK121TN23PROD with NOTICES1