40258 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14360 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2012–N–0280 and FDA– 

2021–N–0371] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Financial Disclosure by Clinical Investigators ......................................................................................................... 0910–0396 5/31/2025 

Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites ........................................ 0910–0872 5/31/2025 

Infant Formula Enforcement Discretion Policy ........................................................................................................ 0910–0903 11/30/2022 

Dated: June 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14358 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1981] 

Drug Supply Chain Security Act 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs; Draft 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 draft 

guidance for industry entitled ‘‘DSCSA 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs.’’ This guidance identifies the 

standards necessary to facilitate 

adoption of secure, interoperable, 

electronic data exchange among the 

pharmaceutical distribution supply 

chain, and clarifies the trading partners, 

products, and transactions subject to 

such standards. This guidance is a 

revision of the draft guidance for 

industry entitled ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs: 

How to Exchange Product Tracing 

Information,’’ issued in November 2014 

as required by the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 6, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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 


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Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 40259 

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– 

2014–D–1981 for ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs.’’ 

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 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, 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Lysette Deshields, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3130, 

drugtrackandtrace@fda.hhs.gov; or 

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 revised draft guidance for industry 

entitled ‘‘DSCSA Standards for the 

Interoperable Exchange of Information 

for Tracing of Certain Human, Finished, 

Prescription Drugs.’’ The Drug Supply 

Chain Security Act (DSCSA) outlines 

requirements for enhanced drug 

distribution security, which include the 

steps to achieve interoperable, 

electronic tracing of products at the 

package level. These requirements for 

enhanced drug distribution security go 

into effect on November 27, 2023. 

Section 582(g)(1) of the FD&C Act (21 

U.S.C. 360eee–1(g)(1)) sets forth 

enhanced drug distribution security 

requirements for trading partners, 

including adherence to standards 

established by FDA for the exchange of 

transaction information and transaction 

statements in a secure, interoperable, 

electronic manner and the verification 

of product at the package level. 

Additionally, section 582(h)(4)(A) of the 

FD&C Act specifies that FDA issue a 

draft guidance, and revise the draft 

guidance as appropriate, to identify and 

make recommendations with respect to 

the standards necessary for adoption in 

order to support the secure, 

interoperable, electronic data exchange 

among the pharmaceutical distribution 

supply chain that comply with a form 

and format developed by a widely 

recognized international standards 

development organization. 

In this revised draft guidance, FDA 

considered the standards established 

pursuant to sections 505D of the FD&C 

Act (21 U.S.C. 355e) and 582(a)(2) of the 

FD&C Act in the November 2014 draft 

guidance entitled ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs: 

How to Exchange Product Tracing 

Information’’ (available at: https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/dscsastandards-interoperable-exchangeinformation-tracing-certain-humanfinished-prescription-drugs). The pilot 

projects conducted per section 582(j) of 

the FD&C Act also informed revisions 

made to this draft guidance. 

This revised draft guidance updates 

the policy articulated in the November 

2014 draft guidance to reflect the 

enhanced drug distribution security 

requirements that will go into effect on 

November 27, 2023, including that 

paper-based methods of product tracing 

will no longer be permitted and 

verification of product at the package 

level will be required, unless a waiver, 

exception, or exemption applies. This 

revised draft guidance is intended to 

facilitate the creation of a uniform 

methodology for product tracing while 

ensuring the protection of confidential 

commercial information and trade 

secrets. FDA also published other 

guidances describing recommendations 

for enhanced drug distribution security, 

including the attributes necessary for 

enhanced product tracing and 

verification, which should be read in 

conjunction with this draft guidance 

(see FDA’s Drug Supply Chain Security 

Law and Policies web page at https://

www.fda.gov/drugs/drug-supply-chainsecurity-act-dscsa/drug-supply-chainsecurity-act-law-and-policies). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 


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40260 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

represent the current thinking of FDA 

on ‘‘DSCSA Standards for the 

Interoperable Exchange of Information 

for Tracing of Certain Human, Finished, 

Prescription Drugs.’’ 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 

This draft guidance includes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). FDA intends to 

solicit public comment and obtain OMB 

approval for any information collections 

recommended in this guidance that are 

new or that would represent substantive 

or material modifications to those 

previously approved collections of 

information found in FDA regulations or 

guidance. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

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

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14342 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Prevention; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given for the meeting of 

the Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Prevention 

National Advisory Council (CSAP NAC) 

on August 8, 2022. The Council was 

established to advise the Secretary, 

Department of Health and Human 

Services (HHS); the Assistant Secretary 

for Mental Health and Substance Use, 

SAMHSA; and Director, CSAP 

concerning matters relating to the 

activities carried out by and through the 

Center and the policies respecting such 

activities. 

The meeting will be open to the 

public and will consist of discussions of 

substance use prevention priorities and 

updates on CSAP program 

developments. 

The meeting will be held via webcast 

and phone only. Attendance by the 

public on-site will not be available. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

Council. Written submissions should be 

forwarded to the contact person on or 

before one week prior to the meeting. 

Oral presentations from the public will 

be scheduled at the conclusion of the 

meeting. Individuals interested in 

making oral presentations should notify 

the contact on or before one week prior 

to the meeting. A maximum of five 

minutes will be allotted for each 

presentation, as time permits. 

To participate in the meeting, submit 

written or brief oral comments, or 

request special accommodations for 

persons with disabilities, please register 

at the SAMHSA Committees’ website: 

https://snacregister.samhsa.gov, or 

communicate with the CSAP Council’s 

Designated Federal Officer (see contact 

information below). 

Substantive program information may 

be obtained after the meeting by 

accessing the SAMHSA Committee 

website, https://www.samhsa.gov/ 

about-us/advisory-councils/csapnational-advisory-council, or by 

contacting the Designated Federal 

Officer. 

Committee Name: Substance Abuse 

and Mental Health Services 

Administration, Center for Substance 

Abuse Prevention National Advisory 

Council. 

Date/Time/Type: August 8, 2022, 

from 12:00 p.m. to 4:00 p.m. EDT: 

(Open). 

Place: (Virtual). For Webcast 

information: please register at the 

SAMHSA Committees’ website, listed 

above. 

Contact: Michelle McVay, Designated 

Federal Officer, SAMHSA CSAP NAC, 

5600 Fishers Lane, Rockville, MD 

20852, Telephone: 240–276–0446, 

Email: michelle.mcvay@

samhsa.hhs.gov. 

Dated: June 29, 2022. 

Carlos Castillo, 

Committee Management Officer, SAMHSA. 

[FR Doc. 2022–14311 Filed 7–5–22; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2022–0002] 

Changes in Flood Hazard 

Determinations 

AGENCY: Federal Emergency 

Management Agency; Department of 

Homeland Security. 

ACTION: Notice; correction. 

SUMMARY: On June 1, 2022, FEMA 

published in the Federal Register a 

changes in flood hazard determination 

notice that contained an erroneous 

table. This notice provides corrections 

to that table to be used in lieu of the 

erroneous information. The table 

provided here represents the changes in 

flood hazard determinations and 

communities affected for the City of 

Margaret and Unincorporated Areas of 

St. Clair County, Alabama. 

FOR FURTHER INFORMATION CONTACT: Rick 

Sacbibit, Chief, Engineering Services 

Branch, Federal Insurance and 

Mitigation Administration, FEMA, 400 

C Street SW, Washington, DC 20472, 

(202) 646–7659, or (email) 

patrick.sacbibit@fema.dhs.gov; or visit 

the FEMA Mapping and Insurance 

eXchange (FMIX) online at https://

www.floodmaps.fema.gov/fhm/fmx_

main.html. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of June 1, 

2022, in FR Doc. 2022–11679, in the 

table on page 33186, the entries for 

Alabama: St. Clair County are corrected 

to read as follows (after the signature): 

Michael M. Grimm, 

Assistant Administrator for Risk 

Management, Department of Homeland 

Security, Federal Emergency Management 

Agency. 


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