Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 9855 

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–D–4974 for ‘‘Advanced 

Manufacturing Technologies 

Designation Program.’’ 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. 

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; or 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: 

With regard to the draft guidance: 

Ranjani Prabhakara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6648, 

Silver Spring, MD 20993, 240–402– 

4652; or James Myers, 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. 

With regard to the proposed collection 

of information: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

5733, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background

In the Federal Register of December

13, 2023, FDA published a notice of 

availability with a 60-day comment 

period to provide comments on the draft 

guidance entitled ‘‘Advanced 

Manufacturing Technologies 

Designation Program’’ and its proposed 

collection of information. FDA has 

received requests to extend the 

comment period to allow sufficient time 

to develop and submit meaningful 

comments. FDA has considered the 

requests and is extending the comment 

period for 30 days, until March 13, 

2024. The Agency believes that this 

extension allows adequate time for 

interested persons to submit comments. 

II. Electronic Access

Persons with access to the internet

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: February 7, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02836 Filed 2–9–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0119] 

Fiscal Year 2024 Generic Drug Science 

and Research Initiatives Workshop; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘FY 2024 Generic 

Drug Science and Research Initiatives 

Workshop.’’ The purpose of the public 

workshop is to provide an overview of 

the status of science and research 

initiatives for generic drugs and an 

opportunity for public input on these 

initiatives. FDA is seeking this input 

from a variety of stakeholders— 


khammond on DSKJM1Z7X2PROD with NOTICES
9856 Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 

industry, academia, patient advocates, 

professional societies, and other 

interested parties—as it fulfills its 

commitment under the Generic Drug 

User Fee Amendments of 2022 (GDUFA 

III) to develop an annual list of science

and research initiatives specific to

generic drugs. FDA will take the

information it obtains from the public

workshop into account in developing its

fiscal year (FY) 2025 Generic Drug User

Fee Amendments (GDUFA) science and

research initiatives.

DATES: The public workshop will be

held on May 20 and 21, 2024. Either

electronic or written comments on this

public workshop must be submitted by

June 21, 2024. See the SUPPLEMENTARY

INFORMATION section for registration date

and information.

ADDRESSES: The public workshop will

be held in person and will be accessible

virtually. Registrants will have an

opportunity to indicate their interest in

attending the public workshop in

person. If there are restrictions imposed

by applicable health guidelines for inperson gatherings, or seating capacity

limitations, registrants interested in

attending the public workshop in

person will be contacted. The public

workshop will be held at the FDA White

Oak Campus, 10903 New Hampshire

Ave., Bldg. 31 Conference Center, the

Great Room (Rm. 1503, sections B and

C), Silver Spring, MD 20993–0002.

Entrance for the public workshop

participants (non-FDA employees) is

through Building 1 where routine

security check procedures will be

performed. For parking and security

information, please refer to https://

www.fda.gov/about-fda/visitorinformation.

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 June 21, 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–0119 for ‘‘FY 2024 Generic 

Drug Science and Research Initiatives 

Workshop; Public Workshop; Request 

for Comments.’’ 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: Sam 

Raney, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4732, Silver Spring, 

MD 20993, 240–402–7967, 

Sameersingh.Raney@fda.hhs.gov; or 

Robert Lionberger, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4722, 

Silver Spring, MD 20993, 240–402– 

7957, Robert.Lionberger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background

In July 2012, Congress passed the

Generic Drug User Fee Amendments of 

2012 (GDUFA I) (Pub. L. 112–144). 

GDUFA I was designed to enhance 

public access to safe, high-quality 

generic drugs and to modernize the 

generic drug program. To support this 

goal, FDA agreed in the Generic Drug 

User Fee Act Program Performance 

Goals and Procedures (GDUFA I 

commitment letter) to work with 

industry and interested stakeholders on 

identifying science and research 

initiatives specific to generic drugs for 

each fiscal year covered by GDUFA I. 

In August 2017, GDUFA was 

reauthorized until September 2022 

through the Generic Drug User Fee 

Amendments of 2017 (GDUFA II) (Pub. 

L. 115–52), and in September 2022,

GDUFA was reauthorized until

September 2027 through the Generic

Drug User Fee Amendments of 2022

(GDUFA III) (Pub. L. 117–180, 136 Stat.

2155). In the GDUFA Reauthorization


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 9857 

1The GDUFA III commitment letter is available 

at https://www.fda.gov/media/153631/download. 

Performance Goals and Program 

Enhancements Fiscal Years 2023–2027 

(GDUFA III commitment letter),1 FDA 

agreed to conduct annual public 

workshops ‘‘to solicit input from 

industry and stakeholders for inclusion 

in an annual list of GDUFA III 

regulatory science initiatives.’’ This 

public workshop scheduled for May 20 

and 21, 2024, seeks to fulfill this 

agreement. 

II. Topics for Discussion at the Public

Workshop

The purpose of this public workshop 

is to obtain input from industry and 

other interested stakeholders on 

identifying generic drug science and 

research initiatives for FY 2025. FDA is 

interested in receiving input about 

regulatory science initiatives for the 

ongoing years of the GDUFA III science 

and research program, and particularly 

for FY 2025. 

Topics discussed during the 

workshop will focus on research that is 

needed to address scientific knowledge 

gaps and associated challenges 

impacting the development and 

regulatory assessment of generic 

products, including complex generics. 

As examples, topics discussed will 

likely relate to nitrosamine drug 

substance-related impurities, drugdevice combination products, predictive 

tools to improve the efficiency of 

generic product development, and other 

topics that can enhance public access to 

high quality, safe and effective generic 

products. Specific presentations and 

discussions at this workshop will be 

announced at a later date and may differ 

from the topics above. Input about the 

topics above will help the Agency 

identify and expand its scientific focus 

for the next fiscal year. 

FDA will consider all comments made 

at this workshop or received through the 

docket (see ADDRESSES) as it develops its 

FY 2025 science and research 

initiatives. Information concerning the 

science and research initiatives for 

generic drugs can be found on the 

Science & Research website at https://

www.fda.gov/drugs/generic-drugs/ 

science-research. 

III. Participating in the Public

Workshop

Registration: Registration is free. 

Persons interested in attending this 

public workshop must register online at 

https://fda.zoomgov.com/webinar/ 

register/WN_qwJcEJcWQeeglLe

ZMD2MCg. Registration may be 

performed at any time before or during 

the workshop. 

If you need special accommodations 

due to a disability, please contact FDA 

via email at GDUFARegulatoryScience@

fda.hhs.gov no later than 11:59 p.m. 

eastern time on May 10, 2024. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present your 

public comments. Requests to provide 

public comments via a pre-recorded 

presentation or a live presentation, 

including in-person or virtual 

presentations, should be submitted via 

email to GDUFARegulatoryScience@

fda.hhs.gov by 11:59 p.m. Eastern Time 

on March 8, 2024. We will do our best 

to accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the workshop. Based upon the public 

comment presentation requests received 

by March 8, 2024, at 11:59 p.m. eastern 

time, we will determine the amount of 

time allotted to each presenter and the 

approximate time each oral presentation 

is to begin; we will select and notify 

participants by April 1, 2024. If selected 

for presentation, any presentation 

materials must be emailed to GDUFA

RegulatoryScience@fda.hhs.gov no later 

than May 10, 2024, 11:59 p.m. eastern 

time. No commercial or promotional 

material will be permitted to be 

presented or distributed at the public 

workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

be webcast. Please register online (as 

described above) to attend the workshop 

remotely (virtually). Registrants will 

receive a hyperlink that provides access 

to the webcast on both days. Although 

FDA verified the website addresses in 

this document, please note that websites 

are subject to change over time. 

Transcripts: Please be advised that as 

soon as a video recording and audio 

transcript of the public workshop are 

available, they will be accessible at 

https://www.regulations.gov or via the 

Science & Research FDA website 

accessible at https://www.fda.gov/drugs/ 

generic-drugs/science-research. They 

may also be available for viewing at the 

Dockets Management Staff (see 

ADDRESSES). 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02841 Filed 2–9–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0945–0005] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before April 12, 2024. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov, PRA@hhs.gov, 

or by calling (202) 264–0041. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0945–0005 and 

project title for reference, to Sherrette A. 

Funn, email: Sherrette.Funn@hhs.gov, 

PRA@hhs.gov, or call (202) 264–0041 

the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Title of the Collection: HIPAA Audit 

Review Survey. 

Type of Collection: Reinstatement, 

with Change, of a Previously Approved 

Collection OMB No. 0945–0005: Office 

for Civil Rights (OCR)—Health 

Information Privacy Division. 

Abstract: This information collection 

consists of 39 online survey questions 

that will be sent to 207 covered entities 

and business associates that participated 

in the 2016–2017 OCR HIPAA Audits. 

The survey will gather information 

relating to the effect of the audits on the 

audited entities and the entities’ 

opinions about the audit process. 

OCR is conducting a review of the 

2016–2017 HIPAA Audits to determine 

its efficacy in assessing the HIPAA 

compliance efforts of covered entities. 


khammond on DSKJM1Z7X2PROD with NOTICES