Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices 83691 

++ QUAD A’s agreement to provide 

CMS with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as CMS may require (including 

corrective action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Vanessa Garcia, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Vanessa Garcia, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2024–23930 Filed 10–16–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4774] 

Temporary Policies for Compounding 

Certain Parenteral Drug Products; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Temporary Policies for Compounding 

Certain Parenteral Drug Products.’’ As of 

October 10, 2024, pursuant to the Public 

Health Service Act (PHS Act), 

Department of Health and Human 

Services (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. 

In late September 2024, Hurricane 

Helene had a devastating impact on one 

of the largest manufacturers of certain 

intravenous and peritoneal dialysis 

solutions in the United States. This 

guidance describes the FDA’s regulatory 

and enforcement priorities regarding the 

compounding of certain parenteral drug 

products by outsourcing facilities and 

by State-licensed pharmacies and 

Federal facilities that are not registered 

with FDA as outsourcing facilities. 

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: 

• 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– 

2024–D–4774 for ‘‘Temporary Policies 

for Compounding Certain Parenteral 

Drug Products.’’ 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)). 


ddrumheller on DSK120RN23PROD with NOTICES1
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