Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 36327 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

Coordination Activities (Coordinator) ....................................................... 6 1 3 18 

Prep Email Request (Director) ................................................................. 9 1 .5 5 

Preparatory Interview (Director, Onsite coordinator) ............................... 18 1 1 18 

Full Interview for Head Start Staff Protocol ............................................. 70 1 1.5 105 

Full Interview for Non-Head Start Staff Protocol ..................................... 12 1 1.5 18 

Estimated Total Annual Burden 

Hours: 164 hours. 

Authority: Head Start Act section 640 

[42 U.S.C. 9835]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–12967 Filed 6–15–22; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0745] 

Voluntary Consensus Standards 

Recognition Program for Regenerative 

Medicine Therapies; Draft Guidance for 

Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

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 draft 

document entitled ‘‘Voluntary 

Consensus Standards Recognition 

Program for Regenerative Medicine 

Therapies; Draft Guidance for Industry.’’ 

The draft guidance describes a 

standards recognition program for 

regenerative medicine therapies (SRP– 

RMT) at FDA’s Center for Biologics 

Evaluation and Research (CBER) 

designed to identify Voluntary 

Consensus Standards (VCS) to facilitate 

the development and assessment of 

regenerative medicine therapy (RMT) 

products regulated by CBER when such 

standards are appropriate. The 

voluntary use of recognized VCS can 

assist stakeholders in more efficiently 

meeting regulatory requirements and 

increasing regulatory predictability for 

RMT products. The program is modeled 

after the formal standards and 

conformity assessment program (S– 

CAP) for medical devices. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 14, 2022 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

Submit either electronic or written 

comments on the collection of 

information by August 15, 2022. 

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– 

2022–D–0745 for ‘‘Voluntary Consensus 

Standards Recognition Program for 

Regenerative Medicine Therapies; Draft 

Guidance for Industry.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES
36328 Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 

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: 

Regarding the draft guidance: Tami 

Belouin, 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. 

Regarding the proposed collection of 

information: 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: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Voluntary 

Consensus Standards Recognition 

Program for Regenerative Medicine 

Therapies; Draft Guidance for Industry.’’ 

The draft guidance describes a program 

at FDA’s CBER for recognition of VCS 

relevant to RMT products regulated in 

CBER. The SRP–RMT is designed to 

identify and recognize VCS to facilitate 

the development and assessment of 

RMT products. The voluntary use of 

recognized VCS can assist stakeholders 

in more efficiently meeting regulatory 

requirements and increasing regulatory 

predictability for RMT products. The 

program parallels the S–CAP for 

medical devices. CBER is issuing this 

draft guidance to obtain public 

comments on the program. 

The draft guidance describes the 

purpose of the program, how the SRP– 

RMT is expected to facilitate RMT 

development, and describes how the 

Office of Tissues and Advanced 

Therapies in CBER generally intends to 

evaluate VCS for recognition in the 

SRP–RMT. This program will not apply 

to: (1) statutory and regulatory standards 

that are legally binding, such as certain 

provisions of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et 

seq.); (2) standards developed by 

Standards Development Organizations 

(SDOs) that do not follow consensus 

mechanisms; or (3) electronic data 

exchange standards for submissions to 

CBER. 

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 ‘‘Voluntary Consensus Standards 

Recognition Program for Regenerative 

Medicine Therapies.’’ 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 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3521), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Request for Recognition of a Voluntary 

Consensus Standard 

OMB Control Number 0910–0338— 

Revision 

Description: The draft guidance for 

industry entitled ‘‘Voluntary Consensus 

Standards Recognition Program for 

Regenerative Medicine Therapies’’ 

provides guidance to industry about a 

program at CBER for recognition of VCS 

relevant to RMT products regulated in 

CBER. The voluntary use of recognized 

standards can assist stakeholders in 

more efficiently meeting regulatory 

requirements and increasing regulatory 

predictability for RMT products. 

The draft guidance describes the 

procedures CBER follows when a 

request for recognition of a VCS is 

received. The draft guidance also 

provides that any interested party may 

request recognition of a VCS. Section V 

of the draft guidance provides that a 

stakeholder can request recognition of a 

specific VCS by submitting an email 

request to SRP–RMT, and recommends 

that the request should, at a minimum, 

contain the following information: 

• Name and electronic or mailing 

address of the requester; 

• Name of the SDO; 

• Title of the VCS; 

• The VCS reference or SDO 

designation number and publication 

date (e.g., Q1234–2019); 

• Proposed list of products for which 

a standard could apply routinely; 

• Rationale for request; and 

• A brief description of the testing, 

performance, or other characteristics of 

the RMT products(s) or process(es) that 

would be addressed by the proposed 

standard. 

We will use the requests to help 

identify for recognition appropriate VCS 

to facilitate the development and 

assessment of RMT products. The 

information is needed to support FDA’s 

efforts to protect the public health and 

increase regulatory predictability for 

RMT products. We are requesting 

approval to revise the information 

collections included in OMB control 

number 0910–0338 to include the 

information collection associated with 

the draft guidance. 

Description of Respondents: 

Respondents to this collection of 

information are product sponsors, 

applicants and other stakeholders 

interested in the development of RMT 

products regulated in CBER. 

We estimate the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 36329 

1 In 2009, Schering Corporation merged with 

Merck and is now referred to as Merck & Co., Inc. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/draft guidance section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for recognition of a voluntary consensus standard/Section V .................................................................... 9 1 9 3 27 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In preparing our estimates of the 

annual number of respondents and the 

average burden per response, we 

reviewed estimates made by other FDA 

Centers regarding similar requests for 

recognition of standards, specifically the 

Center for Devices and Radiological 

Health (83 FR 46740 at 46742; 

September 14, 2018) and the Center for 

Drug Evaluation and Research (84 FR 

4076 at 4078; February 14, 2019). We 

note that standards development is a 

lengthy process and the list of VCS that 

are potentially suitable for recognition 

by CBER is growing but not extensive. 

We determined that it would be 

reasonable to use an estimate of nine 

respondents, consistent with the 

estimates made by the other Centers. 

However, we increased our estimate of 

the amount of time it would take to 

prepare a request from 1 hour to 3 

hours, given the amount of information 

that needs to be included in each VCS 

request. Still, because this is a new 

program, FDA is uncertain of the burden 

and seeks input on this estimate. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12928 Filed 6–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–1154] 

Determination That THEO–DUR 

(Theophylline) Extended-Release 

Tablets, 100 Milligrams and 300 

Milligrams, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that THEO–DUR 

(theophylline) extended-release tablets, 

100 milligrams (mg) and 300 mg, were 

not withdrawn from sale for reasons of 

safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Nisha Shah, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6222, Silver Spring, 

MD 20993–0002, 301–796–4455, 

Nisha.Shah@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

THEO–DUR (theophylline) extendedrelease tablets, 100 mg and 300 mg, are 

the subject of ANDA 085328, currently 

held by Merck & Co., Inc. (previously 

held by Schering Corporation),1 initially 

approved on April 12, 1979. THEO– 

DUR is indicated for the treatment of the 

symptoms and reversible airflow 

obstruction associated with chronic 

asthma and other chronic lung diseases, 

e.g., emphysema and chronic bronchitis. 

In a letter dated March 18, 2003, 

Schering Corporation requested 

withdrawal of ANDA 085328 for THEO– 

DUR (theophylline) extended-release 

tablets. In the Federal Register of May 

5, 2004 (69 FR 25124), FDA announced 

that it was withdrawing approval of 

ANDA 085328, effective June 4, 2004. 

Lachman Consultants submitted a 

citizen petition dated October 25, 2021 

(Docket No. FDA–2021–P–1154), under 

21 CFR 10.30, requesting that the 

Agency determine whether THEO–DUR 

(theophylline) extended-release tablets, 

300 mg, were withdrawn from sale for 

reasons of safety or effectiveness. 


khammond on DSKJM1Z7X2PROD with NOTICES