Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 83887 

Method.’’ 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copies of the draft guidance to the Office 

of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), 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 the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled 

‘‘Recommendations for the 

Development of Blood Collection, 

Processing, and Storage Systems for the 

Manufacture of Blood Components 

Using the Buffy Coat Method.’’ This 

guidance provides recommendations on 

the development of blood collection, 

processing, and storage systems (e.g., 

blood bags with anticoagulant and 

additive solutions, empty bags for 

platelet pooling) used for the 

manufacture of blood and blood 

components intended for transfusion 

using the BC method. This guidance is 

intended for manufacturers of blood 

collection, processing, and storage 

systems. 

Blood and blood components must be 

prepared in a manner consistent with 

the instructions provided by the 

manufacturer (21 CFR 606.65(e)), 

including the directions provided in the 

instructions for use of the approved or 

cleared collection, processing, and 

storage system. To prepare blood 

components using the BC method, blood 

establishments must use blood 

collection, processing and storage 

systems approved or cleared for such 

use. However, blood collection, 

processing, and storage systems 

currently marketed in the United States 

are only approved or cleared for the 

preparation of blood components from 

Whole Blood (WB) using the platelet 

rich plasma method, and none are yet 

approved or cleared for the preparation 

of blood components using the BC 

method. 

This guidance provides 

recommendations to manufacturers who 

wish to obtain FDA approval or 

clearance to market blood collection, 

processing, and storage systems 

intended for the manufacture of blood 

components using the BC method. With 

the availability of such systems, blood 

establishments in the United States 

would have the option of manufacturing 

WB-derived blood components using 

the BC method. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Recommendations for the 

Development of Blood Collection, 

Processing, and Storage Systems for the 

Manufacture of Blood Components 

Using the Buffy Coat Method.’’ 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 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at 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: October 11, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24098 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–2061] 

Review of Drug Master Files in 

Advance of Certain Abbreviated New 

Drug Application Submissions Under 

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 ‘‘Review 

of Drug Master Files in Advance of 

Certain ANDA Submissions Under 

GDUFA.’’ This guidance provides 

information and recommendations on 

the Generic Drug User Fee Amendments 

(GDUFA) III program enhancements 

agreed upon by the Agency and industry 

in ‘‘GDUFA Reauthorization 


khammond on DSKJM1Z7X2PROD with NOTICES
83888 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

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), related 

to the early assessment of certain Type 

II drug master files (DMFs) 6 months 

prior to the submission of certain 

abbreviated new drug applications 

(ANDAs) or prior approval supplements 

(PASs). This guidance describes the 

process outlined in the GDUFA III 

commitment letter in greater detail and 

provides recommendations to DMF 

holders on how to provide the relevant 

information to FDA. This guidance 

finalizes the draft guidance of the same 

title issued on October 6, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 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– 

2022–D–2061 for ‘‘Review of Drug 

Master Files in Advance of Certain 

ANDA Submissions 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: 

Ziyang Su, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave, Bldg. 51, Rm. 4150, Silver Spring, 

MD 20993, 240–402–6004. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Review of Drug Master Files in 

Advance of Certain ANDA Submissions 

Under GDUFA.’’ As described in the 

GDUFA III commitment letter,1 FDA has 

agreed to performance goals and 

program enhancements regarding 

aspects of the generic drug assessment 

program that build on previous 

authorizations of GDUFA. These 

enhancements to the program are 

designed to maximize the efficiency and 

utility of each assessment cycle, with 

the intent of reducing the number of 

assessment cycles for ANDAs and 

facilitating timely access to generic 

medicines for American patients. One of 

the enhancements included in the 

GDUFA III commitment letter is a 

mechanism to enable assessment of 

DMFs in advance of certain ANDA and 

PAS submissions. 

Historically, Type II active 

pharmaceutical ingredient DMFs have 

posed a challenge for ANDA applicants 

because a DMF holder’s response time 

to Agency questions typically limits the 

likelihood that the DMF will be found 

adequate in one ANDA assessment 

cycle, often precluding approval of the 

ANDA in one assessment cycle. The 

program enhancement of early 

assessment of certain Type II DMFs 

should facilitate more DMFs to be found 

adequate in one assessment cycle, 

thereby potentially promoting 

additional ANDA approvals in one 

assessment cycle. 

The purpose of this guidance is to 

provide information and 

recommendations on the early 

assessment of DMFs 6 months prior to 

the submission of certain ANDAs or 

PASs. It describes the process outlined 

in the GDUFA III commitment letter in 

greater detail and provides 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 83889 

recommendations on how to provide the 

relevant information to FDA. 

This guidance finalizes the draft 

guidance of the same title issued on 

October 6, 2022 (87 FR 60686). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized, and in response a footnote 

was added to clarify the potential 

impact of unsolicited amendments 

submitted after the prior assessment is 

granted. 

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 ‘‘Review of Drug 

Master Files in Advance of Certain 

ANDA Submissions 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 final 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 314 have been 

approved under OMB control number 

0910–0001. 

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. 

Dated: October 9, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24104 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3805] 

The Accreditation Scheme for 

Conformity Assessment Program: 

Draft Guidances for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff; 

Availability; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that appeared in 

the Federal Register of September 23, 

2024. In the notice of availability, FDA 

requested comments on three draft 

guidance documents for industry and 

FDA staff entitled ‘‘The Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program; Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff’’; ‘‘Basic 

Safety and Essential Performance of 

Medical Electrical Equipment, Medical 

Electrical Systems, and Laboratory 

Medical Equipment—Standards Specific 

Information for the ASCA Program; 

Guidance for Industry, Accreditation 

Bodies, Testing Laboratories, and FDA 

Staff’’; and ‘‘Biocompatibility Testing of 

Medical Devices—Standards Specific 

Information for the ASCA Program; 

Guidance for Industry, Accreditation 

Bodies, Testing Laboratories, and FDA 

Staff.’’ The Agency is taking this action 

in response to a request for an extension 

to allow interested persons additional 

time to submit comments. 

DATES: FDA is extending the comment 

period on the document published 

September 23, 2024 (89 FR 77526). 

Either electronic or written comments 

must be submitted by December 23, 

2024, to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2019–D–3805 for ‘‘The Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program; Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff’’; ‘‘Basic 

Safety and Essential Performance of 

Medical Electrical Equipment, Medical 

Electrical Systems, and Laboratory 

Medical Equipment—Standards Specific 

Information for the ASCA Program; 

Guidance for Industry, Accreditation 

Bodies, Testing Laboratories, and FDA 

Staff’’; and ‘‘Biocompatibility Testing of 

Medical Devices—Standards Specific 

Information for the ASCA Program; 

Guidance for Industry, Accreditation 

Bodies, Testing Laboratories, and FDA 

Staff.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES