63580 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

Serving as a common claim form, the 

CMS–1500 can be used by other thirdparty payers (commercial and nonprofit 

health insurers) and other Federal 

programs (e.g., TRICARE, RRB, and 

Medicaid). Form Number: CMS–1500 

(OMB Control Number: 0938–1197); 

Frequency: Occasionally; Affected 

Public: Private Sector, Business or other 

for-profit and not-for-profit institutions; 

Number of Respondents: 2,451,781; 

Number of Responses: 975,664,249; 

Total Annual Hours: 17,163,310. (For 

policy questions regarding this 

collection contact Charlene Parks at 

410–786–8684.) 

Dated: September 12, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–20041 Filed 9–14–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3771] 

Annual Status Report Information and 

Other Submissions for Postmarketing 

Requirements and Commitments: 

Using Forms FDA 3988 and FDA 3989; 

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 ‘‘Annual 

Status Report Information and Other 

Submissions for Postmarketing 

Requirements and Commitments: Using 

Forms FDA 3988 and FDA 3989.’’ Forms 

FDA 3988, Transmittal of PMR/PMC 

Submissions for Drugs and Biologics, 

and FDA 3989, PMR/PMC Annual 

Status Report for Drugs and Biologics, 

are intended to facilitate submissions by 

drug and biological product application 

holders of complete and accurate 

information on postmarketing 

requirements (PMRs) and postmarketing 

commitments (PMCs) in a consistent 

format. These forms are expected to 

result in improved accuracy and 

timeliness of FDA’s identification and 

review of those submissions containing 

information on PMRs and PMCs. This 

guidance covers the purpose of each 

form, when to use these forms, and how 

to submit these forms. The guidance 

also explains where applicants will be 

able to find the forms and instructions. 

This guidance finalizes the draft 

guidance of the same name issued on 

October 21, 2020. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 15, 2023. 

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 

should include the Docket No. FDA– 

2018–N–3771 for ‘‘Annual Status Report 

Information and Other Submissions for 

Postmarketing Requirements and 

Commitments: Using Forms FDA 3988 

and FDA 3989.’’ 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 

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 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63581 

1FDA defines postmarketing studies or clinical 

trials for which ASRs must be submitted under 

section 506B of the FD&C Act as those concerning 

a human drug or biological product’s clinical safety, 

clinical efficacy, clinical pharmacology, or 

nonclinical toxicology that are either required by 

FDA (PMRs) or that are committed to, in writing, 

(PMCs) either at the time of approval of an 

application or a supplement or after approval of an 

application or supplement. See §§ 314.81(b)(2)(vii) 

and 601.70. FDA interprets section 506B of the 

FD&C Act to apply to postmarketing studies and 

clinical trials that are required under section 505B 

of the FD&C Act (21 U.S.C. 355c), the animal 

efficacy rule (21 CFR 314.610(b)(1) and 

601.91(b)(1)), accelerated approval (section 

506(c)(2)(A) of the FD&C Act (21 U.S.C. 

356(c)(2)(A)); 21 CFR 314.510 and 601.41), and the 

Food and Drug Administration Amendments Act of 

2007 (section 505(o)(3) of the FD&C Act (21 U.S.C. 

355(o)(3)). 

2Under § 314.81(b)(2)(viii), applicants submitting 

an annual report for human drug products must 

include a status report of postmarketing studies and 

clinical trials not included under § 314.81(b)(2)(vii) 

that are being performed by, or on behalf of, the 

applicant. 

3Available at https://www.gao.gov/products/ 

GAO-16-192. 

4Available at https://oig.hhs.gov/oei/reports/oei01-14-00390.asp. 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Kathy Weil, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5367, Silver Spring, 

MD 20993–0002, 301–796–6054; or 

Anne Taylor, 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 final guidance for industry entitled 

‘‘Annual Status Report Information and 

Other Submissions for Postmarketing 

Requirements and Commitments: Using 

Forms FDA 3988 and FDA 3989.’’ This 

guidance is intended for applicants that 

are required to report annually on the 

status of postmarketing studies and 

clinical trials for human drug and 

biological products under section 506B 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 356b) and its 

implementing regulations at 

§§ 314.81(b)(2)(vii) and 601.70 (21 CFR 

314.81(b)(2)(vii) and 601.70). The forms 

were developed, in part, in response to 

the recommendations from the 

Government Accountability Office 

(GAO) and the Department of Health 

and Human Services (HHS) Office of the 

Inspector General (OIG) regarding the 

need for comparable information across 

annual status reports (ASRs) on PMRs 

and PMCs, to eliminate manual data 

entry and to enhance FDA’s ability to 

track PMRs and PMCs. These forms are 

expected to result in improved accuracy 

and timeliness of FDA’s identification 

and review of those submissions 

containing information on PMRs and 

PMCs. The purpose of the guidance is 

to explain why Forms FDA 3988 and 

FDA 3989 were created, describe the 

contents of the forms, and explain how 

to submit the forms electronically. The 

guidance also explains where applicants 

will be able to find the forms and 

instructions for their completion. Forms 

FDA 3988 and FDA 3989 are available 

for use at FDA’s Forms web page 

(https://www.fda.gov/about-fda/reportsmanuals-forms/forms). 

PMRs and PMCs are studies or 

clinical trials conducted by the 

applicant after FDA has approved a drug 

or biological product for marketing or 

licensing. These studies or clinical trials 

can be required under statute or 

regulation (PMRs) or agreed upon in 

writing by FDA and the applicant 

(PMCs). Section 130(a) of the Food and 

Drug Administration Modernization Act 

of 1997 amended the FD&C Act by 

adding section 506B of the FD&C Act. 

Under section 506B of the FD&C Act 

and its implementing regulations at 

§§ 314.81(b)(2)(vii) and 601.70, 

applicants must submit an ASR on 

PMRs and PMCs.1 This report must 

address the progress of the PMR/PMC or 

the reasons for failing to conduct the 

requirement or commitment (section 

506B(a) of the FD&C Act). 

This guidance does not apply to 

postmarketing studies or clinical trials 

that are not subject to the reporting 

requirements of section 506B of the 

FD&C Act.2 For example, the guidance 

does not apply to voluntary studies or 

clinical trials performed by an applicant 

or on an applicant’s behalf that are 

neither required nor agreed upon in 

writing. This guidance also does not 

apply to PMCs related to chemistry, 

manufacturing, and controls or stability 

studies. 

In a December 2015 report from the 

GAO entitled ‘‘Drug Safety: FDA 

Expedites Many Applications, but Data 

for Postapproval Oversight Need 

Improvement,’’ 3 the GAO 

recommended that FDA improve its 

data tracking to ensure the 

completeness, timeliness, and accuracy 

of information in its database on PMRs/ 

PMCs. Additionally, in a July 2016 HHS 

OIG study entitled ‘‘FDA is Issuing 

More Postmarketing Requirements, but 

Challenges with Oversight Persist,’’ 4 the 

HHS OIG noted that FDA continued to 

have problems with its data 

management system and work 

processes, thereby hindering its ability 

to track PMRs. OIG recommended that 

FDA provide standardized forms for 

ASRs, ensure that the forms are 

complete, and require applicants to 

submit the forms electronically. 

Based in part on the 

recommendations from GAO and HHS 

OIG, FDA created Forms FDA 3988 and 

FDA 3989 to improve the collection, 

identification, and use of information 

regarding PMRs and PMCs. Form FDA 

3988 was developed to accompany an 

applicant’s PMR/PMC-related 

submissions (e.g., draft protocols, final 

protocols, interim reports, final reports, 

and PMR/PMC-related correspondence), 

except the ASR on PMRs and PMCs. 

Form FDA 3988 allows applicants to 

identify, in a standardized format, the 

type of PMR/PMC-related submission 

the applicant is making (e.g., draft 

protocol) and the PMR or PMC to which 

the submission applies. Form FDA 3989 

was developed so that applicants may 

provide ASR information on their PMRs 

and PMCs in a standardized format. The 

purpose of these forms is to assist 

applicants in providing clearly 

identified PMR/PMC-related 

submissions and in meeting their 

annual reporting requirements under 

section 506B of the FD&C Act and 

§§ 314.81(b)(2)(vii) and 601.70. 

Use of Forms FDA 3988 and 3989 is 

optional, but FDA encourages their use 

because the forms should facilitate FDA 

management and review of the 

applicant’s submissions, as well as 

enhance the accuracy of data within 

FDA’s electronic document archiving 

systems. FDA uses these archiving 

systems as a source from which to 

obtain data published annually in the 

Federal Register as required under 

section 506B(c) of the FD&C Act and to 

provide quarterly status updates of the 

PMR and PMC data on FDA’s 

Postmarket Requirements and 

Commitments public web page 

(available at https://

www.accessdata.fda.gov/scripts/cder/ 

pmc/index.cfm). This guidance finalizes 

the draft guidance of the same name 

issued on October 21, 2020 (85 FR 

66995). In addition to editorial changes 

for clarification, changes from the draft 

to the final included a minor change 

regarding what to enter into field 9.g. of 

Form FDA 2252 and the removal of the 

appendices to the guidance, which 

contained drafts of Forms FDA 3988 and 

3989. 

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 ‘‘Annual Status 


ddrumheller on DSK120RN23PROD with NOTICES1
63582 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

Report Information and Other 

Submissions for Postmarketing 

Requirements and Commitments: Using 

Forms FDA 3988 and FDA 3989.’’ 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. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information for applicants required to 

submit ASRs on PMCs and PMRs under 

section 506B of the FD&C Act and the 

implementing regulations at 

§§ 314.81(b)(2)(vii) and 601.70 are 

approved under OMB control numbers 

0910–0001 and 0910–0338, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: September 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20014 Filed 9–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5966] 

Breakthrough Devices Program; 

Guidance for Industry and Food and 

Drug Administration Staff; 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 entitled ‘‘Breakthrough 

Devices Program.’’ This final guidance 

describes policies that FDA intends to 

use to implement a section of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). This guidance updates the 

previous version of the guidance, of the 

same title, issued on December 18, 2018, 

and describes how the Breakthrough 

Devices Program may also be applicable 

to certain devices that benefit 

populations impacted by health and/or 

healthcare disparities. Consistent with 

our obligations under the SUPPORT for 

Patients and Communities Act 

(SUPPORT Act), the Breakthrough 

Devices Program may be available for 

certain non-addictive medical products 

to treat pain or addiction. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 15, 2023. 

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– 

2017–D–5966 for ‘‘Breakthrough 

Devices Program.’’ 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 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 


ddrumheller on DSK120RN23PROD with NOTICES1