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draft guidance as the guidance was 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
83890 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

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: Eric 

Franca, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5500, Silver Spring, 

MD 20993–0002, 301–796–4505, 

ASCA@fda.hhs.gov; 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, 240–402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 23, 2024, 

FDA published a notice of availability 

with a 60-day comment period to 

request comments on draft guidances 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 has received a request for 

an extension of the comment period. 

The request conveyed concern that the 

current 60-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response. 

FDA has considered the request and 

is extending the comment period for the 

notice of availability for 30 days, until 

December 23, 2024. The Agency 

believes that a 30-day extension allows 

adequate time for interested persons to 

submit comments without significantly 

delaying guidance on these important 

issues. 

Dated: October 10, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24096 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–2024–E–0128] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Wavewriter Alpha Spinal 

Cord Stimulator System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for WAVEWRITER ALPHA SPINAL 

CORD STIMULATOR SYSTEM and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that medical 

device. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by December 17, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

April 16, 2025. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: 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 

December 17, 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.’’ 


khammond on DSKJM1Z7X2PROD with NOTICES