1416 Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 

CMS–10286 Notice of Research 

Exception under the Genetic 

Information Nondiscrimination 

CMS–10325 Disclosure and 

Recordkeeping Requirements for 

Grandfathered Health Plans under the 

Affordable Care Act 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘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 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, 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. 

Information Collection 

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: 

Occasionally; Affected Public: Private 

Sector; State, Local or Tribal 

governments; Number of Respondents: 

2; Total Annual Responses: 2; Total 

Annual Hours: 0.5. For policy questions 

regarding this collection contact Usree 

Bandyopadhyay at 410–786–6650. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Disclosure and 

Recordkeeping Requirements for 

Grandfathered Health Plans under the 

Affordable Care Act; Use: Section 1251 

of the Affordable Care Act provides that 

certain plans and health insurance 

coverage in existence as of March 23, 

2010, known as grandfathered health 

plans, are not required to comply with 

certain statutory provisions in the Act. 

The final regulations titled ‘‘Final Rules 

under the Affordable Care Act for 

Grandfathered Plans, Preexisting 

Condition Exclusions, Lifetime and 

Annual Limits, Rescissions, Dependent 

Coverage, Appeals, and Patient 

Protections’’ (80 FR 72192, November 

18, 2015) require that, to maintain its 

status as a grandfathered health plan, a 

plan must maintain records 

documenting the terms of the plan in 

effect on March 23, 2010, and any other 

documents that are necessary to verify, 

explain or clarify status as a 

grandfathered health plan. The plan 

must make such records available for 

examination upon request by 

participants, beneficiaries, individual 

policy subscribers, or a state or federal 

agency official. A grandfathered health 

plan is also required to include a 

statement in any summary of benefits 

under the plan or health insurance 

coverage, that the plan or coverage 

believes it is a grandfathered health plan 

within the meaning of section 1251 of 

the Affordable Care Act, and providing 

contact information for participants to 

direct questions and complaints. In 

addition, a grandfathered group health 

plan that is changing health insurance 

issuers is required to provide the 

succeeding health insurance issuer (and 

the succeeding health insurance issuer 

must require) documentation of plan 

terms (including benefits, cost sharing, 

employer contributions, and annual 

limits) under the prior health insurance 

coverage sufficient to make a 

determination whether the standards of 

paragraph § 147.140(g)(1) of the final 

regulations are exceeded. It is also 

required that, for an insured group 

health plan (or a multiemployer plan) 

that is a grandfathered plan, the relevant 

policies, certificates, or contracts of 

insurance, or plan documents must 

disclose in a prominent and effective 

manner that employers, employee 

organizations, or plan sponsors, as 

applicable, are required to notify the 

issuer (or multiemployer plan) if the 

contribution rate changes at any point 

during the plan year. Form Number: 

CMS–10325 (OMB control number: 

0938–1093); Frequency: Occasionally; 

Affected Public: Private Sector, State, 

Local or Tribal governments; Number of 

Respondents: 14,669; Total Annual 

Responses: 2,651,523; Total Annual 

Hours: 40. For policy questions 

regarding this collection contact Usree 

Bandyopadhyay at 410–786–6650. 

Dated: January 6, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–00344 Filed 1–10–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Judicial, Court, and Attorney 

Measures of Performance (New 

Collection) 

AGENCY: Children’s Bureau; 

Administration for Children and 

Families; HHS. 

ACTION: Request for public comment. 

SUMMARY: The Children’s Bureau, 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

proposing to collect data for a new 

descriptive study, Judicial, Court, and 

Attorney Measures of Performance 

(JCAMP). 

DATES: Comments due within 60 days of 

publication. In compliance with the 

Paperwork Reduction Act of 1995, ACF 

is soliciting public comment on the 

specific aspects of the information 

collection described in this notice. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 1417 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: This study will collect 

information from Court Improvement 

Program (CIP) staff to (1) understand 

data capacity and current use of 

performance measures and (2) gather 

feedback from the performance measure 

pilot process. This will be accomplished 

using two instruments: 

JCAMP CIP Data Capacity Survey 

The survey asks CIPs about their 

current capacity to collect specific data 

elements from the following six 

categories of measurement: (1) Legal and 

judicial context (e.g., court docketing), 

(2) Practices (e.g., attorney pre-petition 

legal practice), (3) Short-term outcomes 

that happen during hearings (e.g., 

discussion of key issues), (4) 

Intermediate outcomes that happen 

during the case (e.g., judicial 

continuity), (5) Long-term outcomes that 

happen after case closure (e.g., child 

safety), and (6) Cross-cutting themes 

(e.g., equity). The survey asks about 

capacity broadly and then specifically 

for a series of subcategories. 

JCAMP Pilot Site Debrief Form 

The JCAMP Pilot Site Debrief Form is 

a survey developed to be administered 

to CIP staff who have assisted with 

piloting of the performance measures. 

The survey asks participants about the 

challenges and successes in collecting 

pilot data for the measures, their 

confidence in collecting the data going 

forward, and suggestions for improving 

future efforts. 

Respondents: Respondents include 

CIP Administrators and staff. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Annual 

burden hours 

JCAMP CIP Data Capacity Survey ..................................... 106 1 .83 264 88 

JCAMP Pilot Debrief Form .................................................. 24 1 .25 18 6 

Estimated Total Annual Burden 

Hours: 94. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Section 5106, Public Law 

111–320, the Child Abuse Prevention 

and Treatment Act Reauthorization Act 

of 2010, and titles IV–B and IV–E of the 

Social Security Act. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–00238 Filed 1–10–22; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0053] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, 

Drug, and Cosmetic Act; Draft 

Guidance for Industry 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 the draft 

guidance entitled ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ The Federal Food, Drug, and 

Cosmetic Act (FD&C Act) requires 

manufacturers to notify FDA of a 

permanent discontinuance in the 

manufacture of certain devices or an 

interruption in the manufacture of 

certain devices that is likely to lead to 

a meaningful disruption in supply of 

that device in the United States. This 

guidance is intended to assist 

manufacturers in providing timely, 

informative notifications about changes 

in the production of certain medical 

device products that will help prevent 

or mitigate shortages of such devices 

during or in advance of a public health 

emergency. FDA is issuing this guidance 

to implement amendments to the FD&C 

Act by the Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act), as 

it relates to device shortages and 

potential device shortages during or in 

advance of a public health emergency. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES