Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Notices 28015 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Notice of 

Research Exception under the Genetic 

Information Nondiscrimination Act; 

Use: Under the Genetic Information 

Nondiscrimination Act of 2008 (GINA), 

a plan or issuer may request (but not 

require) a genetic test in connection 

with certain research activities so long 

as such activities comply with specific 

requirements, including: (i) The 

research complies with 45 CFR part 46 

or equivalent federal regulations and 

applicable State or local law or 

regulations for the protection of human 

subjects in research; (ii) the request for 

the participant or beneficiary (or in the 

case of a minor child, the legal guardian 

of such beneficiary) is made in writing 

and clearly indicates that compliance 

with the request is voluntary and that 

non-compliance will have no effect on 

eligibility for benefits or premium or 

contribution amounts; and (iii) no 

genetic information collected or 

acquired will be used for underwriting 

purposes. The Secretary of Labor or the 

Secretary of Health and Human Services 

is required to be notified if a group 

health plan or health insurance issuer 

intends to claim the research exception 

permitted under Title I of GINA. 

Nonfederal governmental group health 

plans and issuers solely in the 

individual health insurance market or 

Medigap market will be required to file 

with the Centers for Medicare & 

Medicaid Services (CMS). The Notice of 

Research Exception under the Genetic 

Information Nondiscrimination Act is a 

model notice that can be completed by 

group health plans and health insurance 

issuers and filed with either the 

Department of Labor or CMS to comply 

with the notification requirement. Form 

Number: CMS–10286, OMB control 

number: 0938–1077; Frequency: On 

Occasion; Affected Public: Private 

Sector; State, Local or Tribal 

governments; Number of Respondents: 

2; Total Annual Responses: 2; Total 

Annual Hours: 1. (For policy questions 

regarding this collection contact Usree 

Bandyopadhyay at 410–786–6650) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: The PACE 

Organization (PO) Monitoring and Audit 

Process in 42 CFR part 460; Use: 

Sections 1894(e)(4) and 1934(e)(4) of the 

Act and the implementing regulations at 

42 CFR 460.190 and 460.192 state that 

CMS, in conjunction with the State 

Administering Agency (SAA), must 

oversee a PACE organization’s 

continued compliance with the 

requirements for a PACE organization. 

The data collected with the data 

request tools included in this package 

allow CMS to conduct a comprehensive 

review of PACE organizations’ 

compliance in accordance with specific 

federal regulatory requirements. The 

information gathered during this audit 

will be used by the Medicare Parts C 

and D Oversight and Enforcement 

Group (MOEG) within the Center for 

Medicare (CM), as well as the SAA, to 

assess POs’ compliance with PACE 

program requirements. If outliers or 

other data anomalies are detected, other 

offices within CMS will work in 

collaboration with MOEG for follow-up 

and resolution. Additionally, POs will 

receive the audit results, and will be 

required to implement corrective action 

to correct any identified deficiencies. 

Form Number: CMS–10630 (OMB 

control number: 0938–1327); Frequency: 

Annually; Affected Public: Private 

Sector, State, Local, or Tribal 

Governments and Business or other forprofit institutions; Number of 

Respondents: 40; Total Annual 

Responses: 40; Total Annual Hours: 

31,200. (For policy questions regarding 

this collection contact Kathleen 

Flannery at 410–786–6722.) 

Dated: May 5, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–10026 Filed 5–9–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0939] 

Determination That GLUCOTROL 

(Glipizide) Tablets, 2.5 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 GLUCOTROL 

(glipizide) tablets, 2.5 milligrams (mg), 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for glipizide 

tablets, 2.5 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: Dan 

Ritterbeck, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6219, Silver Spring, 

MD 20993–0002, 301–796–4673, 

Daniel.Ritterbeck@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. 

GLUCOTROL (glipizide) tablets, 2.5 

mg, are the subject of NDA 017783, held 

by Pfizer Inc., and initially approved on 

May 8, 1984. GLUCOTROL is indicated 

as an adjunct to diet and exercise to 

improve glycemic control in adults with 

type 2 diabetes mellitus. 


lotter on DSK11XQN23PROD with NOTICES1
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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