28016 Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Notices 

GLUCOTROL (glipizide) tablets, 2.5 

mg, are currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Hyman, Phelps & McNamara, P.C., 

submitted a citizen petition dated 

August 24, 2021 (Docket No. FDA– 

2021–P–0939), under 21 CFR 10.30, 

requesting that the Agency determine 

whether GLUCOTROL (glipizide) 

tablets, 2.5 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

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 GLUCOTROL (glipizide) 

tablets, 2.5 mg, were not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that 

GLUCOTROL (glipizide) tablets, 2.5 mg, 

were withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

GLUCOTROL (glipizide) tablets, 2.5 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product was withdrawn from sale for 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 GLUCOTROL (glipizide) 

tablets, 2.5 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. 

ANDAs that refer to GLUCOTROL 

(glipizide) tablets, 2.5 mg, may 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: May 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09944 Filed 5–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–N–1721; FDA– 

2005–N–0101; FDA–2021–N–0386; FDA– 

2012–N–0294; and FDA–2018–N–3404] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: The 

following is a list of FDA information 

collections approved recently by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Investigational New Drug Regulations .................................................................................................................... 0910–0014 3/31/2025 

Prescription Drug User Fee Program ...................................................................................................................... 0910–0297 3/31/2025 

Medical Device Reporting ........................................................................................................................................ 0910–0437 3/31/2025 

Food Additives; Food Contact Substances Notification System ............................................................................. 0910–0495 3/31/2025 

Generic Drug User Fee Program ............................................................................................................................ 0910–0727 3/31/2025 

Dated: May 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10017 Filed 5–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0168] 

Benefit-Risk Considerations for 

Product Quality Assessments; Draft 

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 draft 

guidance for industry entitled ‘‘BenefitRisk Considerations for Product Quality 

Assessments.’’ This guidance describes 

the benefit-risk principles applied by 

FDA when conducting product qualityrelated assessments of chemistry, 

manufacturing, and controls (CMC) 

information submitted for FDA 

assessment as part of original new drug 

applications (NDAs), original biologics 

license applications (BLAs), or 

supplements to such applications, in 

addition to other information (e.g., 

inspectional findings) available to FDA 

during its assessment. This guidance 

discusses how FDA assesses risks, 

sources of uncertainty, and possible 

mitigation strategies for a product 

quality-related issue and how those 

considerations inform FDA’s 

understanding of the potential effect on 

a product. This guidance also discusses 

how unresolved product quality issues 

may be addressed in the context of 

regulatory decision making. The 

guidance notes that product quality 

assessments are also done for 

abbreviated new drug applications 

(ANDAs), and it discusses how, in 

certain rare circumstances, unresolved 

product quality issues may be addressed 

when there is an urgent clinical need for 


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