3928 Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices 

SUPPLEMENTARY INFORMATION: Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb-4a), FDA will report the 

issuance of material threat MCM 

priority review vouchers and the 

approval of products for which a 

voucher was redeemed. FDA has 

determined that the application for 

QULIPTA (atogepant) tablets, approved 

September 28, 2021, meets the 

redemption criteria. 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For

further information about QULIPTA

(atogepant) tablets go to the ‘‘Drugs@

FDA’’ website at https://

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

daf/.

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01108 Filed 1–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5451] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prescription Drug 

Marketing: Administrative Procedures, 

Policies, and Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 information 

collection associated with Agency 

regulations that govern prescription 

drug marketing. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 22, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 22, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received 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– 

2023–N–5451 for ‘‘Prescription Drug 

Marketing: Administrative Procedures, 

Policies, and Requirements.’’ 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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–976–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices 3929 

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 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing 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. 

Prescription Drug Marketing: 

Administrative Procedures, Policies, 

and Requirements—21 CFR Part 203 

OMB Control Number 0910–0435— 

Extension 

This information collection helps 

support FDA regulations. Specifically, 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended by the 

Prescription Drug Marketing Act of 1987 

(Pub. L. 100–293) (PDMA) and 

Prescription Drug Amendments of 1992, 

establishes requirements for the: (1) 

reimportation and wholesale 

distribution of prescription drugs; (2) 

sale, purchase, or trade of, or the offer 

to sell, purchase, or trade, prescription 

drugs that were purchased by hospitals 

or healthcare entities or donated to 

charitable organizations; and (3) 

distribution of prescription drug 

samples. Because insufficient safeguards 

existed over the drug distribution 

system to prevent the introduction and 

retail sale of substandard, ineffective, or 

counterfeit drugs, and that a wholesale 

drug diversion submarket had 

developed that prevented effective 

control over the true sources of drugs, 

PDMA was enacted. PDMA is intended 

to ensure that drug products purchased 

by consumers are safe and effective and 

to avoid an unacceptable risk that 

counterfeit, adulterated, misbranded, 

subpotent, or expired drugs are sold. 

Requirements under PDMA are codified 

at part 203 (21 CFR part 203), 

Prescription Drug Marketing. 

The regulations in part 203 include 

reporting and recordkeeping 

requirements intended to help achieve 

the following goals to: (1) ban the 

reimportation of prescription drugs 

produced in the United States, except 

when reimported by the manufacturer 

or under FDA authorization for 

emergency medical care; (2) ban the 

sale, purchase, or trade, or the offer to 

sell, purchase, or trade, of any 

prescription drug sample; (3) limit the 

distribution of drug samples to 

practitioners licensed or authorized to 

prescribe such drugs or to pharmacies of 

hospitals or other healthcare entities at 

the request of a licensed or authorized 

practitioner; (4) require licensed or 

authorized practitioners to request 

prescription drug samples in writing; (5) 

mandate storage, handling, and 

recordkeeping requirements for 

prescription drug samples; and (6) 

prohibit, with certain exceptions, the 

sale, purchase, or trade, or the offer to 

sell, purchase, or trade, of prescription 

drugs that were purchased by hospitals 

or other healthcare entities or that were 

donated or supplied at a reduced price 

to a charitable organization. 

Respondents: Respondents to the 

information collection are persons or 

entities engaged in prescription drug 

marketing as described in FDA 

regulations at part 203. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 2

§ 203.11; Reimportation ........................................ 1 1 1 0.5 (30 minutes) ........... 0.5 

§ 203.37(a); Falsification of records ..................... 140 2.14 300 0.25 (15 minutes) ......... 75 

§ 203.37(b); Loss or theft of samples ................... 140 57.14 8,000 0.25 (15 minutes) ......... 2,000 

§ 203.37(c); Convictions ....................................... 1 1 1 1 .................................... 1 

§ 203.37(d); Contact person ................................. 20 1 20 0.08 (5 minutes) ........... 2 

§ 203.39(g); Reconciliation report ......................... 1 1 1 1 .................................... 1 

Total ............................................................... ........................ ........................ 8,323 ....................................... 2,080 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Subpart C: Sale restrictions 

§ 203.23(a) and (b); Returned drugs .................... 2,200 71.99 158,380 0.25 (15 minutes) ......... 39,595 

§ 203.23(c); Returned drugs storage documentation.2,200 71.99 158,380 0.08 (5 minutes) ........... 12,670 


ddrumheller on DSK120RN23PROD with NOTICES1
3930 Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Subpart D: Samples 

§§ 203.30 to 203.39; documentation regarding 

sample distribution.

140 46,716.67 6,540,334 0.08 (5 minutes) ........... 523,227 

Total ............................................................... ........................ ........................ 6,857,094 ....................................... 575,492 

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

Based on a review of Agency data, 

since our last request for OMB approval, 

we have adjusted our estimate of 1 

burden to reflect an increase of 

6,492,354 responses and 516,028 hours 

annually. The estimates in table 1 (a 

decrease of 19,700 responses and 4,928 

hours since the last OMB approval) 

reflect an assessment of the volume of 

loss/theft/falsification reports received 

by the Agency under § 203.37 over the 

past 18 months. While the requirements 

have not changed, we believe this more 

accurately reflects the number of reports 

estimated to be submitted to FDA under 

this section. Our adjustments to table 2 

are attributable to a more accurate 

reflection of the number of drug sample 

requests received by manufacturers and 

authorized distributors of record. The 

PDMA does not require manufacturers 

and distributors to report the number of 

drug sample requests they receive to 

FDA. However, section 6004 of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) requires that 

manufacturers and authorized 

distributors submit to FDA annually the 

identity and quantity of drug samples 

requested, among other information. 

Dated: January 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01079 Filed 1–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting—TriClip 

G4 System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Circulatory System Devices Panel of the 

Medical Devices Advisory Committee. 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. The meeting will be open to the 

public. 

DATES: The meeting will take place 

virtually on February 13, 2024, from 9 

a.m. to 6 p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked questions, 

including information regarding special 

accommodations due to a disability, 

may be accessed at: https://

www.fda.gov/advisory-committees/ 

about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings. 

FOR FURTHER INFORMATION CONTACT: 

Akinola Awojope, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg., 66, Rm. 5214, Silver Spring, 

MD 20993–0002, Akinola.Awojope@

fda.hhs.gov, 301–636–0512, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On February 

13, 2024, the committee will discuss, 

make recommendations, and vote on 

information regarding the premarket 

approval application (PMA) for the 

TriClip G4 System by Abbott Medical. 

The proposed Indication for Use 

statement is as follows: The TriClip G4 

System is indicated for the 

improvement of health status in patients 

with symptomatic severe tricuspid 

regurgitation despite being treated 

optimally with medical therapy, who 

are at intermediate or greater risk for 

surgery and in whom tricuspid valve 

edge-to-edge repair is appropriate as 

determined by a heart team. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down and select the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 2, 2024. 

Oral presentations from the public will 

be scheduled on February 13, 2024, 

between approximately 1 p.m. and 2 

p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 


ddrumheller on DSK120RN23PROD with NOTICES1