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
Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices 3931 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before January 25, 2024. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 29, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at AnnMarie.Williams@

fda.hhs.gov or 240–507–6496 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). This meeting notice also 

serves as notice that, pursuant to 21 CFR 

10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: January 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01082 Filed 1–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Translating Research to Practice to End the 

Overdose Crisis. 

Date: February 14–15, 2024. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892. 

Contact Person: Sheila Pirooznia, Ph.D., 

Scientific Review Officer, Division of 

Extramural Review, Scientific Review 

Branch, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, (301) 496–9350, 

sheila.pirooznia@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIDA– 

K Alternate SEP. 

Date: February 21, 2024. 

Time: 12:00 p.m. to 1:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892. 

Contact Person: Marisa Srivareerat, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Office of Extramural Policy, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 435–1258, 

marisa.srivareerat@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: January 16, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–01048 Filed 1–19–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Development of Software for 

Data Science in Infectious and ImmuneMediated Diseases Research (U01 Clinical 

Trial Not Allowed). 

Date: March 6–7, 2024. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Sandip Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20852, sandip.bhattacharyya@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 17, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–01131 Filed 1–19–24; 8:45 am] 

BILLING CODE 4140–01–P 


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