Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 73031 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0053] 

Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers; Revised Draft 

Guidance for Industry; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

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 revised 

draft guidance for industry entitled 

‘‘Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers.’’ This revised 

draft guidance, when finalized, will 

provide FDA’s current thinking on 

common questions regarding certain 

communications by firms to health care 

providers (HCPs) of scientific 

information on unapproved use(s) of 

approved/cleared medical products (the 

scope of the italicized terms is further 

explained in the revised draft guidance). 

This revised guidance supersedes the 

revised draft guidance entitled 

‘‘Distributing Scientific and Medical 

Publications on Unapproved New 

Uses—Recommended Practices’’ issued 

in 2014 (2014 revised draft guidance). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 26, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

December 26, 2023. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2008–D–0053 for ‘‘Communications 

From Firms to Health Care Providers 

Regarding Scientific Information on 

Unapproved Uses of Approved/Cleared 

Medical Products: Questions and 

Answers.’’ 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 the draft 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; 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; 

the Office of Policy, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002; or the Policy and 

Regulations Staff, (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Kathleen David, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Room 3203, 

Silver Spring, MD 20993–0002, 301– 

796–1200; Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 


ddrumheller on DSK120RN23PROD with NOTICES1
73032 Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911; Ana Loloei, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5504, 

Silver Spring, MD 20993–0002, 301– 

796–8774; Office of Surveillance and 

Compliance, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl. 

(HFV–6), Rockville, MD 20855, 240– 

402–7082; Julie Finegan, Office of 

Policy, Office of the Commissioner, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4252, Silver Spring, MD 20993–0002, 

301–827–4830. 

With regard to the proposed collection 

of information: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10 a.m.–12 p.m., 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Communications From Firms 

to Health Care Providers Regarding 

Scientific Information on Unapproved 

Uses of Approved/Cleared Medical 

Products: Questions and Answers.’’ 

Specifically, this revised draft guidance 

relates to firms sharing the following 

types of communications with HCPs: 

• published scientific or medical 

journal articles (reprints), 

• published clinical reference 

resources, as follows: 

Æ clinical practice guidelines (CPGs), 

Æ scientific or medical reference texts 

(reference texts), 

Æ materials from independent clinical 

practice resources, and 

• firm-generated presentations of 

scientific information from an 

accompanying published reprint. 

For the purposes of this revised draft 

guidance, these specific types of 

communications from firms to HCPs of 

scientific information on unapproved 

uses (SIUU) of approved/cleared 

medical products in combination with 

the disclosures recommended in the 

guidance are referred to as ‘‘SIUU 

communications.’’ We acknowledge that 

firms share SIUU communications 

through different media (e.g., paper, 

digital), and the recommendations in 

this guidance apply regardless of the 

medium of the communication. Other 

communications by firms are not 

specifically addressed by this revised 

draft guidance, and we do not intend to 

convey any views on such 

communications in issuing this revised 

draft guidance. 

This revised draft guidance represents 

a continuation of FDA’s ongoing efforts 

to consider, develop, and refine its 

policies and recommendations relating 

to communications by firms about 

unapproved uses of their approved/ 

cleared medical products. In 2009, FDA 

issued a final guidance for industry 

entitled ‘‘Good Reprint Practices for the 

Distribution of Medical Journal Articles 

and Medical or Scientific Reference 

Publications on Unapproved New Uses 

of Approved Drugs and Approved or 

Cleared Medical Devices’’ (74 FR 1694) 

to provide guidance to firms on 

distributing ‘‘journal articles’’ and 

‘‘scientific or medical reference 

publications.’’ Then, FDA issued the 

2014 revised draft guidance (79 FR 

11793) to clarify the Agency’s position 

on firms disseminating scientific or 

medical reference texts and CPGs that 

include information on unapproved 

uses of the firm’s medical products and 

to provide additional explanation on 

these topics. 

In developing this revised draft 

guidance, FDA considered stakeholder 

feedback, including comments received 

on the 2014 revised draft guidance. This 

revised draft guidance will supersede 

the 2014 revised draft guidance. 

Changes include a revised title, a 

question-and-answer format, and certain 

changes in scope. 

The Federal Food, Drug, and Cosmetic 

Act, the Public Health Service Act, and 

their implementing regulations prohibit, 

among other things, the introduction (or 

causing the introduction) into interstate 

commerce of a medical product that 

fails to comply with applicable 

premarket requirements or is otherwise 

misbranded or adulterated. This 

prohibition includes introducing (or 

causing the introduction) into interstate 

commerce a medical product that is 

intended for a use that has not been 

approved or cleared by FDA, even if that 

same product is approved or cleared for 

a different use. These premarket 

requirements further multiple important 

government interests and distributing 

approved/cleared medical products for 

unapproved uses can undermine these 

interests. In certain circumstances, 

however, HCPs may be interested in 

scientific information about unapproved 

uses of approved/cleared medical 

products to inform clinical practice 

decisions for the care of an individual 

patient. In developing this draft 

guidance, FDA has sought to strike a 

careful balance between supporting HCP 

interest in scientific information about 

unapproved uses of approved/cleared 

medical products to inform clinical 

practice decisions for the care of an 

individual patient, and mitigating the 

potential that the government interests 

advanced by these statutory 

requirements will be undermined. 

In light of those goals, FDA believes 

it is critical that SIUU communications 

be truthful, non-misleading, factual and 

unbiased and provide all information 

necessary for HCPs to interpret the 

strengths and weaknesses and validity 

and utility of the information in the 

SIUU communication. In addition, any 

study or analysis described in a source 

publication that serves as the basis for 

an SIUU communication should be 

scientifically sound. The studies or 

analyses should also provide 

information that is relevant to HCPs 

engaged in making clinical practice 

decisions for the care of an individual 

patient (as used in this revised draft 

guidance, ‘‘clinically relevant’’). The 

manner of presentation of SIUU 

communications is also critical to 

consider. This revised draft guidance 

provides recommendations addressing 

all of these considerations. 

If a firm shares an SIUU 

communication with HCPs in a manner 

that is consistent with the 

recommendations in this revised draft 

guidance, FDA does not intend to use 

such communication standing alone as 

evidence of a new intended use. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The revised draft guidance, 

when finalized, will represent the 

current thinking of FDA on 

‘‘Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers.’’ 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 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3521), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 73033 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Recommendations for Drug and Device 

Manufacturer Communications With 

Payors, Formulary Committees, and 

Similar Entities; and Communications 

From Firms to Health Care Providers 

Regarding Scientific Information on 

Unapproved Uses of Approved/Cleared 

Medical Products 

Questions and Answers 

OMB Control Number 0910–0857— 

Revision 

The revised draft guidance document, 

‘‘Communications From Firms to Health 

Care Providers Regarding Scientific 

Information on Unapproved Uses of 

Approved/Cleared Medical Products: 

Questions and Answers,’’ discusses 

information disclosures that we 

recommend firms include in SIUU 

communications if the firms choose to 

publicly share such communications. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Recommended disclosure activity; guidance section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

A statement that the unapproved use(s) of the medical 

product has not been approved by FDA and that the 

safety and effectiveness of the medical product for 

the unapproved use(s) has not been established; Q2.

1,008 30 30,240 0.1 (6 minutes) .... 3,024 

A statement disclosing the FDA-approved use(s) of the 

medical product, including any limitations of use 

specified in the FDA-required labeling; Q2.

1,008 27 27,216 0.1 (6 minutes) .... 2,721.6 

A statement disclosing any limitations, restrictions, cautions, or warnings described in the FDA-required labeling about the unapproved use(s); Q2.1,008 5 5,040 0.2 (12 minutes) .. 1,008 

A copy of the most current FDA-required labeling (or a 

mechanism for obtaining this labeling, as appropriate); Q2.

1,008 27 27,216 0.1 (6 minutes) .... 2,721.6 

A statement describing any contraindication(s) in the 

FDA-required labeling for the medical product; Q2.

1,008 3 3,024 0.1 (6 minutes) .... 302.4 

A statement describing any serious, life-threatening, or 

fatal risks posed by the medical product that are in 

the FDA-required labeling for the medical product or 

known by the firm and that are relevant to the unapproved use(s). If a risk evaluation and mitigation 

strategy (REMS) has been established under 21 

U.S.C. 355–1, the statement should disclose that 

fact and should describe the goal(s) of the REMS; 

Q2.

1,008 25 25,200 0.2 (12 minutes) .. 5,040 

A statement identifying any authors, editors, or other 

contributors to publication(s) included in the SIUU 

communication who were employees of or consultants to or who received compensation from the firm 

at the time of writing, editing, or contributing to the 

publication, to the extent that a firm acting reasonably would know of such relationship; Q2.

1,008 20 20,160 0.2 (12 minutes) .. 4,032 

In the case of an SIUU communication that is based 

on a source publication that is primarily focused on a 

particular scientific study or studies, for each such 

study where the following information is not included 

in the publication, provide a description of: 

1,008 20 20,160 2.75 ..................... 55,440 

—All material aspects of study design, methodology, and results; 

—All material limitations related to the study design, methodology, and results; and 

—When applicable, conclusions from other relevant studies that are contrary to, or cast doubt 

on, the results shared, including citations for any 

such studies; Q2. 


ddrumheller on DSK120RN23PROD with NOTICES1
73034 Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

Recommended disclosure activity; guidance section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

The publication date of any referenced or included 

publication(s) (if not specified in the publication or citation); Q2.

1,008 3 3,024 0.1 (6 minutes) .... 302.4 

When firms share an SIUU communication in the form 

of an unabridged CPG or reference text in its entirety that discusses a wide range of medical products and that discussion is not primarily focused on 

one or more of a firm’s medical products, the firm 

should include, in lieu of some of the specific disclosures listed above, a more general statement in the 

SIUU communication, such as ‘‘This [CPG/reference 

text] describes some uses of medical products that 

are not approved by the FDA and the safety and effectiveness of any unapproved use(s) have not been 

established.’’; Q4.

1,008 3 3,024 0.1 (6 minutes) .... 302.4 

When firms share an SIUU communication in the form 

of a firm-generated presentation of scientific information from an accompanying reprint that SIUU communication should clearly disclose what portions of 

the communication are firm-generated; Q4.

1,008 10 10,080 0.1 (6 minutes) .... 1,008 

Total ........................................................................ ........................ ........................ 174,384 ............................. 75,902.4 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a current listing of firms 

promoting approved/cleared human and 

animal drug products (747), combined 

with an estimated number of device 

firms marketing products (261), we 

assume 1,008 firms (‘‘number of 

respondents’’ in table (1) may each 

choose to publicly share 30 SIUU 

communications annually. Our estimate 

of the burden per disclosure (2.5 hours) 

reflects what we believe is the average 

burden based on the number and 

content and complexity of disclosures 

as recommended in the guidance. 

III. Request for Comment on Other 

Issues for Consideration 

FDA is interested in additional 

matters related to communications by 

firms about scientific information on 

unapproved use(s) of approved/cleared 

medical products. This revised draft 

guidance pertains to these 

communications by firms to HCPs 

engaged in making clinical practice 

decisions for the care of an individual 

patient. FDA is specifically seeking 

input on the following: 

1. What considerations, if any, exist 

that are unique to communications of 

scientific information about unapproved 

use(s) of approved/cleared medical 

products by firms to researchers 

(including HCPs working in their 

capacity as researchers)? 

2. What other factors should firms 

consider when sharing firm-generated 

presentations (as described in the draft 

guidance) to ensure that presentations 

are truthful, non-misleading, factual and 

unbiased and provide all information 

necessary for HCPs to interpret the 

strengths and weaknesses and validity 

and utility of the presented information? 

IV. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// 

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm, 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: October 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23372 Filed 10–23–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Request for Public Comment 

on Proposed Update to the Bright 

Futures Periodicity Schedule as Part of 

the HRSA-Supported Preventive 

Services Guidelines for Infants, 

Children, and Adolescents 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice seeks public 

comment on a proposed update to the 

Periodicity Schedule of the Bright 

Futures Recommendations for Pediatric 

Preventive Health Care (‘‘Bright Futures 

Periodicity Schedule’’), as part of the 

HRSA-supported preventive services 

guidelines for infants, children, and 

adolescents. 

DATES: Members of the public are 

invited to provide written comments on 

the proposed update no later than 

November 24, 2023. All comments 

received on or before this date will be 

reviewed and considered by the Bright 

Futures Periodicity Schedule Working 

Group and provided for further 

consideration by HRSA in determining 

the recommended updates that it will 

support. 


ddrumheller on DSK120RN23PROD with NOTICES1