Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 6449 

requirements of PDMA, PDA, or this 

part, remains responsible for creating 

and maintaining all requests, receipts, 

forms, reports, and records required 

under PDMA, PDA, and this part. 

* * * * * 

■ 11. In § 203.37, revise paragraph (e) to 

read as follows: 

§ 203.37 Investigation and notification 

requirements. 

* * * * * 

(e) Whom to notify at FDA. 

Notifications and reports concerning 

samples of human prescription drugs or 

biological products that are regulated by 

the Center for Drug Evaluation and 

Research shall be made via email to 

PDMAREPORTS@fda.hhs.gov. 

Alternatively, reports and 

correspondence concerning such 

samples may be made via regular mail 

to the Office of Drug Security, Integrity, 

and Response, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Silver Spring, MD 

20993–0002, ATTN: PDMA Reports. 

Notifications and reports concerning 

samples of human prescription 

biological products regulated by the 

Center for Biologics Evaluation and 

Research shall be made to the Food and 

Drug Administration, Center for 

Biologics Evaluation and Research, 

Document Control Center, 10903 New 

Hampshire Ave., Bldg. 71, Rm. G112, 

Silver Spring, MD 20993–0002. 

Subpart E [Removed and Reserved] 

■ 12. Remove and reserve subpart E, 

consisting of § 203.50. 

Dated: January 24, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–01927 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 203 

[Docket No. FDA–2011–N–0446] 

Removal of Certain Requirements 

Related to the Prescription Drug 

Marketing Act; Opportunity for Public 

Comment; Withdrawal 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the withdrawal of the 

proposed rule ‘‘Removal of Certain 

Requirements Related to the 

Prescription Drug Marketing Act; 

Opportunity for Public Comment,’’ 

published in the Federal Register on 

July 14, 2011. FDA is taking this action 

because the proposed changes are 

duplicative of another FDA proposed 

rulemaking, which is also being 

published in this issue of the Federal 

Register, that is intended to conform 

with newly established definitions and 

requirements set out by the Drug Supply 

Chain Security Act of 2013 (DSCSA). 

DATES: The proposed rule published 

July 14, 2011 (76 FR 41434), is 

withdrawn as of February 4, 2022. 

ADDRESSES: For access to the docket, 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. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Weisbuch, Center for Drug 

Evaluation and Research, Office of 

Compliance, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–9362, AaronWeisbuch@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Quality and Security Act 

(DQSA) was enacted on November 27, 

2013. The DQSA contains two titles: 

Title I, the Compounding Quality Act, 

and Title II, the DSCSA (Pub. L. 113– 

54). The DSCSA amended Chapter V of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) by adding Subchapter H 

(Pharmaceutical Distribution Supply 

Chain), sections 581 through 585 (21 

U.S.C. 360eee through 360eee–4), and 

by amending section 503(e) of the FD&C 

Act (21 U.S.C. 353(e)). As amended, 

sections 503(e) and 583 of the FD&C Act 

require the Secretary to establish 

national prescription drug wholesale 

distributor licensure standards. In 

addition, section 582 of the FD&C Act 

establishes prescription drug product 

tracing requirements for wholesale 

distributors and their trading partners. 

On July 14, 2011, FDA proposed to 

remove § 203.50(a) (21 CFR 203.50(a)). 

Before that rulemaking was finalized, 

the DSCSA was enacted. Section 204 of 

the DSCSA amended section 503(e)(1) 

through (3) of the FD&C Act with 

additional and different requirements 

for wholesale distributors. The DSCSA 

also added new requirements for 

wholesale distributors, including 

phased-in prescription drug tracing 

requirements in section 582(c) of the 

FD&C Act. Because of the changes to 

requirements for wholesale distributors 

under the DSCSA, the Agency’s 

proposed rule published on July 14, 

2011, to remove § 203.50(a), was never 

finalized. 

In its proposed rulemaking entitled 

‘‘Certain Requirements Regarding 

Prescription Drug Marketing,’’ 

published elsewhere in this issue of the 

Federal Register, FDA will propose a 

rule that will seek to amend part 203 (21 

CFR part 203) to remove provisions no 

longer in effect and incorporate 

conforming changes following 

enactment of the DSCSA. In the 

proposed rulemaking, the Agency will 

clarify provisions to avoid potential 

confusion with the new standards for 

wholesale distribution established by 

the DSCSA. The amendments to part 

203 in the proposed rule will include 

the removal of § 203.50 in its entirety, 

rendering the proposed rule published 

July 14, 2011, removing § 203.50(a), 

obsolete. 

II. Withdrawal of the Proposed Rule 

As result of these efforts, FDA is 

withdrawing the proposed rule 

‘‘Removal of Certain Requirements 

Related to the Prescription Drug 

Marketing Act; Opportunity for Public 

Comment,’’ published in the Federal 

Register of July 14, 2011. 

The withdrawal of this proposed rule 

does not preclude the Agency from 

reinstituting rulemaking concerning the 

issues addressed in the proposal. 

Should we decide to undertake such 

rulemakings in the future, we will repropose the actions and provide new 

opportunities for comment. 

Furthermore, this proposed rule is only 

intended to address the withdrawal of 

the proposed rule on ‘‘Removal of 

Certain Requirements Related to the 

Prescription Drug Marketing Act; 

Opportunity for Public Comment,’’ 

published in the Federal Register of 

July 14, 2011, and not any other 

pending proposals that the Agency has 

issued or is considering. If you need 

additional information about the subject 

matter of the withdrawn proposed rule, 

visit the Agency’s website at https://

www.fda.gov for any current 

information on the matter. 

Dated: January 24, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–01928 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 


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