77526 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

1. ‘‘PDUFA Reauthorization 

Performance Goals and Procedures 

Fiscal Years 2023 Through 2027’’ at 

https://www.fda.gov/media/151712/ 

download. 

2. FDA guidance for industry 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ (May 

2014): https://www.fda.gov/media/ 

86377/download. 

3. FDA guidance for industry 

‘‘Providing Regulatory Submissions in 

Electronic Format—Certain Human 

Pharmaceutical Product Applications 

and Related Submissions Using the 

eCTD Specifications’’ (Rev. 7) (February 

2020): https://www.fda.gov/media/ 

135373/download. 

4. FDA guidance for industry ‘‘Process 

Validation: General Principles and 

Practices’’ (Rev. 1) (January 2011): 

https://www.fda.gov/files/drugs/ 

published/Process-Validation-GeneralPrinciples-and-Practices.pdf. 

5. CDER MAPP 5015.13: ‘‘Quality 

Assessment for Products in Expedited 

Programs’’ (December 2022): https://

www.fda.gov/media/162786/ 

download?attachment. 

6. FDA draft guidance for industry 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ (Rev. 1) (September 2023): 

https://www.fda.gov/media/172311/ 

download. 

7. CDER MAPP 6025.6: ‘‘Good Review 

Practice: Management of Breakthrough 

Therapy-Designated Drugs and 

Biologics’’ (Rev. 1) (February 2024): 

https://www.fda.gov/media/89155/ 

download. 

8. CBER ‘‘SOPP 8101.1: Regulatory 

Meetings With Sponsors and Applicants 

for Drugs and Biological Products’’ 

(March 2023). 

9. CBER ‘‘SOPP 8212: Breakthrough 

Therapy Products—Designation and 

Management’’ (August 2023). 

Dated: September 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21674 Filed 9–20–24; 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 Food and Drug 

Administration Staff; 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 three 

draft guidance documents for the 

Accreditation Scheme for Conformity 

Assessment Program 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 

Accreditation Scheme for Conformity 

Assessment (ASCA) Program: Guidance 

for Industry, Accreditation Bodies, 

Testing Laboratories, and FDA Staff;’’ 

and ‘‘Biocompatibility Testing of 

Medical Devices—Standards Specific 

Information for the Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff.’’ In 

accordance with amendments made by 

the FDA User Fee Reauthorization Act 

of 2022 (FUFRA), part of the Medical 

Device User Fee Amendments of 2022 

(MDUFA V), FDA was directed to 

conclude the Pilot Accreditation 

Scheme for Conformity Assessment 

Program by the end of fiscal year 2023 

and continue to operate the program 

(hereafter referred to as the ASCA 

Program) consistent with the amended 

FD&C Act. FDA is publishing these draft 

guidance documents which, when 

finalized, are intended to provide 

updates to improve the ASCA Program. 

These draft guidance documents are not 

final nor for implementation at this 

time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 22, 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 Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff;’’ and 

‘‘Biocompatibility Testing of Medical 

Devices—Standards Specific 

Information for the Accreditation 


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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77527 

Scheme for Conformity Assessment 

(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 

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)). 

Electronic copies of these three 

guidance documents are available for 

download from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidances. Submit written requests for 

single hard copies of the draft guidance 

documents 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 Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff’’; and 

‘‘Biocompatibility Testing of Medical 

Devices—Standards Specific 

Information for the Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff’’ to the 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

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: 

I. Background 

FDA has concluded the ASCA pilot 

phase and is establishing an ongoing 

ASCA Program, in accordance with 

amendments made to section 514 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360d) by section 2005 of the 

FDA User Fee Reauthorization Act of 

2022, part of the Medical Device User 

Fee Amendments of 2022. The three 

final ASCA Pilot guidance documents 

issued on September 25, 2020, are also 

being updated to make improvements to 

the ASCA Program based on lessons 

learned during ASCA’s pilot phase and 

to convey the commitments stipulated 

in MDUFA V. These draft guidance 

updates incorporate feedback received 

through public meetings and webinars, 

the docket, stakeholder meetings, 

communications with participating 

accreditation bodies and testing 

laboratories, and lessons learned 

internally from review staff and ASCA 

staff during the pilot phase. The updates 

will also allow FDA to appropriately 

expand ASCA per MDUFA V 

commitments and expectations. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidances, when 

finalized, will represent the current 

thinking of FDA on the ASCA Program. 

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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov, https://

www.fda.gov/regulatory-information/

search-fda-guidance-documents, or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘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 Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff;’’ and 

‘‘Biocompatibility Testing of Medical 

Devices—Standards Specific 

Information for the Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document numbers GUI00017037, 

GUI00020011, and/or GUI00020012, 

respectively, and complete title(s) to 

identify the guidance(s) you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 


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77528 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

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 the following table have 

been approved by OMB: 

21 CFR part; guidance; or FDA form Topic OMB 

Control No. 

‘‘The Accreditation Scheme for Conformity Assessment 

(ASCA) Program’’.

ASCA Program ..................................................................................... 0910–0889 

807, subpart E .................................................................... Premarket notification ........................................................................... 0910–0120 

814, subparts A through E ................................................. Premarket approval .............................................................................. 0910–0231 

814, subpart H .................................................................... Humanitarian Device Exemption .......................................................... 0910–0332 

812 ...................................................................................... Investigational Device Exemption ........................................................ 0910–0078 

860, subpart D .................................................................... De Novo classification process ............................................................ 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions ...................................................................................... 0910–0756 

803 ...................................................................................... Medical Devices; Medical Device Reporting; Manufacturer reporting, 

importer reporting, user facility reporting, distributor reporting.

0910–0437 

820 ...................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) 

Regulation.

0910–0073 

58 ........................................................................................ Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.0910–0119 

Dated: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21673 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2583] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Drug 

Compounding, Repackaging, and 

Related Activities Regarding Sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 23, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The OMB 

control number for this information 

collection is 0910–0858. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Human Drug Compounding, 

Repackaging, and Related Activities 

Regarding Sections 503A and 503B of 

the Federal Food, Drug, and Cosmetic 

Act 

OMB Control Number 0910–0858— 

Extension 

This information collection helps 

support implementation of sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 353a and 21 U.S.C. 353b), which 

govern compounding by pharmacies, 

outsourcing facilities, and other entities. 

Compounding is generally a practice in 

which a licensed pharmacist, a licensed 

physician, or, in the case of an 

outsourcing facility, a person under the 

supervision of a licensed pharmacist, 

combines, mixes, or alters ingredients of 

a drug to create a medication tailored to 

the needs of an individual patient. 

Although compounded drugs can serve 

an important medical need for certain 

patients, they also present risks to 

patients. FDA’s compounding program 

aims to protect patients from unsafe, 

ineffective, and poor-quality 

compounded drugs, while preserving 

access to lawfully marketed 

compounded drugs for patients who 

have a medical need for them. 

Respondents to the information 

collection are pharmacies, outsourcing 

facilities, and other entities. 

To assist respondents in complying 

with statutory requirements, we have 

issued the following topic-specific 

guidance documents: 

TABLE 1—PUBLISHED GUIDANCE DOCUMENTS REGARDING SECTIONS 503A AND 503B OF THE FD&C ACT

Title Notice of availability publication date 

Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities (Radiopharmaceutical Compounding and Repackaging 

Guidance) (available at https://www.fda.gov/media/102615/download).

September 26, 2018 (83 FR 48633). 


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