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Activity/draft guidance section Number of 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may obtain the draft guidance at either 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Milligrams, Were Not Withdrawn From 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
36330 Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 

Although the citizen petition did not 

address the 100-mg strength, that 

strength has also been discontinued. On 

our own initiative, we have also 

determined whether that strength was 

withdrawn for safety or effectiveness 

reasons. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that THEO–DUR 

(theophylline) extended-release tablets, 

100 mg and 300 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of THEO– 

DUR (theophylline) extended-release 

tablets, 100 mg and 300 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list THEO–DUR 

(theophylline) extended-release tablets, 

100 mg and 300 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: June 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12920 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–2013–N–0514] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Procedures for Clinical Laboratory 

Improvement Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

implementation of the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 15, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 15, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 15, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is 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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–0514 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Administrative Procedures for Clinical 

Laboratory Improvement Amendments 

Categorization.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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 


khammond on DSKJM1Z7X2PROD with NOTICES