83692 Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices 

Submit written requests for single 

copies of the guidance to the Office of 

Communications, Division of Drug 

Information, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Hillandale Bldg., 4th Floor, Silver 

Spring, MD 20993–0002. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Gabrielle Cosel, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As of October 10, 2024, pursuant to 

section 319(a) of the Public Health 

Service Act (42 U.S.C. 247d) (PHS Act), 

HHS Secretary Becerra has determined 

that public health emergencies (PHEs) 

exist as a result of the consequences of 

Hurricane Helene in the States of North 

Carolina, Florida, Georgia, Tennessee, 

and South Carolina, and as a result of 

the consequences of Hurricane Milton 

in the State of Florida. FDA is aware of 

reports from hospitals, health systems, 

and State-licensed pharmacies that they 

have experienced difficulties obtaining 

certain intravenous solutions. FDA is 

closely monitoring this situation and 

using all of its applicable authorities to 

work with the manufacturers of 

intravenous solutions to increase 

supply. For example, FDA has 

facilitated the temporary importation of 

intravenous solution products from 

certain foreign facilities, detailed at: 

https://www.fda.gov/drugs/updates2024-hurricane-season/hurricanehelene-baxters-manufacturing-recoverynorth-carolina. 

However, we recognize that hospitals, 

health systems, State-licensed 

pharmacies, and applicable Federal 

facilities have concerns about assuring 

access to intravenous solutions as the 

impacts of the hurricanes continue. 

Therefore, FDA is issuing this policy to 

describe the FDA’s regulatory and 

enforcement priorities regarding the 

compounding of certain parenteral drug 

products for hospitals by outsourcing 

facilities and by State-licensed 

pharmacies and Federal facilities that 

are not registered with FDA as 

outsourcing facilities. 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Temporary Policies for Compounding 

Certain Parenteral Drug Products.’’ We 

are issuing this guidance consistent 

with our good guidance practices (GGP) 

regulation (§ 10.115 (21 CFR 10.115)). 

We are implementing this guidance 

without prior public comment because 

we have determined that prior public 

participation is not feasible or 

appropriate (§ 10.115(g)(2)). This 

guidance document is being 

implemented immediately to help 

ensure patient access to certain 

parenteral drug products, such as 

intravenous fluids, which are essential 

in the care of patients, including those 

who are critically ill and those 

undergoing surgery. Although this 

guidance document is immediately in 

effect, it remains subject to comment in 

accordance with FDA’s GGP regulation. 

The guidance represents the current 

thinking of FDA on ‘‘Temporary Policies 

for Compounding Certain Large Volume 

Parenteral Drug Products for Hospitals.’’ 

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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

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

3501–3521). The collections of 

information for current good 

manufacturing practice requirements 

have been approved under OMB control 

number 0910–0139. The collections of 

information for registration of human 

drug compounding outsourcing 

facilities under section 503B of the 

FD&C Act and associated fees under 

section 744K of the FD&C Act (21 U.S.C. 

379j–62) have been approved under 

OMB control number 0910–0776. The 

collections of information for human 

drug compounding and adverse event 

reporting under sections 503A and 503B 

(21 U.S.C. 353a and 353b) of the FD&C 

Act have been approved under OMB 

control number 0910–0800. The 

collections of information for adverse 

event and product experience reporting 

under the MedWatch System has been 

approved under OMB control number 

0910–0291. 

To the extent this guidance also 

contains a new collection of information 

not approved under a current collection, 

a PHE waiver from the PRA has been 

granted by HHS on October 11, 2024, 

under section 319(f) of the Public Health 

Service Act. Information concerning the 

PHE PRA waiver can be found on the 

HHS website at https://aspe.hhs.gov/ 

public-health-emergency-declarationpra-waivers. 

III. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: October 11, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23954 Filed 10–16–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5868] 

Requests for Reconsideration at the 

Division Level Under the Generic Drug 

User Fee Amendments; 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 final 

guidance for industry entitled ‘‘Requests 

for Reconsideration at the Division 

Level Under GDUFA.’’ This guidance 

provides recommendations on the 

procedures for applicants of abbreviated 

new drug applications (ANDAs) that 

wish to pursue a request for 

reconsideration within the review 

discipline at the division level or 

original signatory authority. This 

guidance reflects the most recent 

reauthorization of the Generic Drug User 

Fee Amendments (GDUFA III) and 

clarifies what matters are appropriate 

for requests for reconsideration. This 

guidance finalizes the draft guidance for 

industry of the same title issued on 

January 11, 2024. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 17, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices 83693 

• 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– 

2017–D–5868 for ‘‘Requests for 

Reconsideration at the Division Level 

Under GDUFA.’’ 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 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

David Coppersmith, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1673, 

Silver Spring, MD 20903, 301–796– 

9193, David.Coppersmith@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Requests for Reconsideration at the 

Division Level Under GDUFA.’’ This 

guidance provides recommendations on 

the procedures for applicants of ANDAs 

that wish to pursue a request for 

reconsideration within the review 

discipline at the division level or 

original signatory authority. Requests 

within the scope of this guidance 

document should concern certain 

actions that relate to an ANDA and have 

scientific significance. 

During the assessment of an ANDA, 

FDA considers important issues that are 

central to product evaluation. 

Sometimes, an applicant may disagree 

with FDA, and because these 

disagreements often involve intricate 

matters, it is critical to have procedures 

in place to ensure open and prompt 

consideration of an applicant’s 

concern(s). The procedures and policies 

described in this guidance are intended 

to formalize FDA’s current and 

historical practices and to continue to 

promote rapid and fair resolution of 

eligible requests between an applicant 

and FDA. 

This guidance finalizes the draft 

guidance for industry of the same title 

issued on January 11, 2024 (89 FR 

1923). FDA received no comments on 

the draft guidance. No changes were 

made other than editorial changes. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Requests for 

Reconsideration at the Division Level 

Under GDUFA.’’ 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

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

3501–3521). The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information pertaining to the GDUFA III 

commitment letter, meetings related to 

generic drug development, and the 

Generic Drug User Fee Program have 

been approved under OMB control 

number 0910–0727. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

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

www.regulations.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1
83694 Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices 

Dated: October 9, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23967 Filed 10–16–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request; Generic 

Information Collection Request for 

Health Resources and Services 

Administration Stakeholder Gatherings 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than November 18, 

2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Umbrella Generic Information 

Collection Request for Information 

Collections Related to HRSA Gatherings, 

OMB No. 0906–xxxx—New. 

Abstract: HRSA conducts gatherings 

for various purposes, including 

conferences, meetings, workshops, 

webinars, trainings, communities of 

practice, focus groups, and other inperson or virtual gatherings for 

individuals and organizations that are 

interested in HRSA programs. To ensure 

that HRSA has sufficient information to 

plan, convene, administer, and evaluate 

the effectiveness of these gatherings, 

HRSA must collect information from 

potential attendees, such as contact 

information, organizational information, 

logistical information (e.g., preferred 

delivery methods), accommodation 

needs, and feedback about the 

gathering’s content. Furthermore, HRSA 

may conduct a test of knowledge to see 

what attendees know about the subject 

matter before or during the meeting or 

focus group. After the gathering 

concludes, attendees may be asked to 

complete an evaluation form and/or a 

test of knowledge to measure the 

gathering’s effectiveness. In some 

instances, attendees may also apply 

and/or submit an abstract for 

prescreening to be selected for 

attendance. 

An illustrative, but not exhaustive, 

list of examples of standardized 

information collection activities related 

to HRSA gatherings include: 

• Registration Forms: Information 

collected includes name, contact 

information, organization/affiliation, 

demographic information (age, race or 

ethnicity, occupation, and location), and 

attendee accommodation needs. 

• Application Forms for panels, 

posters, or other presentation formats: 

For application forms, information 

collected also includes title, author(s), 

organization/affiliation, and 

presentation abstract, in addition to the 

information contained in the 

registration form. 

• Focus Groups: Information 

collected includes attendee/presenter 

responses to standard questions 

regarding topics posed to smaller groups 

during HRSA gatherings. 

• Pre-/Post-gathering Forms: 

Information collected includes attendee/ 

presenter preferences, feedback, pre-/ 

post-meeting questions, and tests of 

knowledge in response to standard 

questions. 

A 60-day notice published in the 

Federal Register on June 21, 2024, 89 

FR 52067–68. HRSA received one 

comment that was outside the scope of 

the proposed information collection. 

Need and Proposed Use of the 

Information: The purpose of collections 

under this umbrella generic information 

collection is to gather appropriate 

information to plan, administer, and 

evaluate HRSA gatherings. While HRSA 

can evaluate the general need for and 

the overall practical utility of such 

information collection in advance, 

HRSA may not be able to determine the 

details of the specific individual 

collections until a later time. The 

planning for these gatherings is often on 

a quick timeline and the standard 

timeline to comply with a full request 

under the Paperwork Reduction Act 

could inhibit HRSA’s ability to collect 

information to inform these activities. 

The information collected is expected to 

be voluntary, low-burden, and 

uncontroversial. Therefore, an umbrella 

generic is requested to allow for quick 

turnaround requests for similar 

information collections related to these 

activities. 

As this Generic ICR for HRSA 

Stakeholder Gatherings will focus on 

the awareness, understanding, attitudes, 

preferences, or experiences of HRSA 

customers or other stakeholders (e.g., 

funding recipients and their delivery 

partners, potential funding applicants) 

relating to existing or future services, 

products, or communication materials, 

the Fast Track Process should apply to 

this information collection. Therefore, 

HRSA requests OMB provide a response 

on individual generic information 

collections within 5 business days. 

Likely Respondents: Attendees and 

presenters at HRSA conferences, 

meetings, workshops, webinars, 

trainings, communities of practice, and 

other in-person, virtual, or hybrid 

gatherings. Attendees and presenters 

may include HRSA funding recipients, 

individuals seeking to participate in a 

HRSA-funded program, members of the 

public who utilize HRSA-funded 

resources, contractors, researchers, and 

other members of the public. Responses 

to any information collections under 

this Generic ICR for HRSA Stakeholder 

Gatherings are not required to obtain or 

retain any benefit. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. HRSA 

conducted this estimate based on 

reviewing burden estimates of forms 


ddrumheller on DSK120RN23PROD with NOTICES1