Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Notices 22539 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. 

The collections of information in 21 

CFR part 314 relating to the submission 

of new drug applications, abbreviated 

new drug applications, and 

supplemental applications and the 

submission of requests to waive in vivo 

BA and BE requirements have been 

approved under OMB control number 

0910–0001. 

The collections of information in 21 

CFR part 312 relating to the submission 

of investigational new drug applications 

and BA/BE studies or pharmacogenomic 

data and the collections of information 

in part 320 for drug safety reporting 

have been approved under OMB control 

numbers 0910–0014 and 0910–0291. 

The collections of information in 21 

CFR parts 50 and 56 relating to the 

protection of human subjects and 

investigational review boards have been 

approved under OMB control number 

0910–0130. 

The collections of information in 21 

CFR 201.56 and 201.57 for the 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products have been 

approved under OMB control number 

0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://

www.regulations.gov, or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08114 Filed 4–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting of the Advisory 

Committee on Heritable Disorders in 

Newborns and Children (ACHDNC or 

Committee), authorized under section 

1111(g) of the Public Health Service Act, 

and the Federal Advisory Committee 

Act, on Thursday, May 12, 2022, and 

Friday, May 13, 2022. Information about 

the ACHDNC and the agenda for this 

meeting can be found on the ACHDNC 

website at https://www.hrsa.gov/ 

advisory-committees/heritabledisorders/index.html. 

DATES: Thursday, May 12, 2022, from 

10:00 a.m. to 3:20 p.m. Eastern Time 

(ET) and Friday, May 13, 2022, from 

10:00 a.m. to 12:40 p.m. ET. 

ADDRESSES: This meeting will be held 

via webinar. While this meeting is open 

to the public, advance registration is 

required. 

Please register online at https://

www.achdncmeetings.org/registration/ 

by the deadline of 12:00 p.m. ET on May 

11, 2022. Instructions on how to access 

the meeting via webcast will be 

provided upon registration. 

FOR FURTHER INFORMATION CONTACT: 

Alaina Harris, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Room 18W66, Rockville, 

Maryland 20857; 301–443–0721; or 

ACHDNC@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACHDNC 

provides advice and recommendations 

to the Secretary of Health and Human 

Services (Secretary) on the development 

of newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. ACHDNC reviews 

and reports regularly on newborn and 

childhood screening practices, 

recommends improvements in the 

national newborn and childhood 

screening programs, and fulfills 

requirements stated in the authorizing 

legislation. In addition, ACHDNC’s 

recommendations regarding inclusion of 

additional conditions for screening on 

the Recommended Uniform Screening 

Panel (RUSP), following adoption by the 

Secretary, are evidence-informed 

preventive health services provided for 

in the comprehensive guidelines 

supported by HRSA pursuant to section 

2713 of the Public Health Service Act 

(42 U.S.C. 300gg–13). Under this 

provision, non-grandfathered group 

health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance are 

required to provide insurance coverage 

without cost-sharing (a co-payment, coinsurance, or deductible) for preventive 

services for plan years (i.e., policy years) 

beginning on or after the date that is one 

year from the Secretary’s adoption of the 

condition for screening. 

During the May 12–13, 2022, meeting, 

ACHDNC will hear from experts in the 

fields of public health, medicine, 

heritable disorders, rare disorders, and 

newborn screening. Agenda items 

include the following: 

(1) Final evidence-based review report 

on the guanidinoacetate 

methyltransferase (GAMT) deficiency 

condition nomination for possible 

inclusion on the RUSP. Following this 

report, the ACHDNC expects to vote on 

whether to recommend the Secretary 

add GAMT deficiency to the RUSP; 

(2) An update on the Krabbe disease 

condition nomination; 

(3) A possible vote on whether to 

move Krabbe disease forward to full 

evidence-based review; 

(4) A presentation on homocystinuria 

newborn screening status; and 

(5) A presentation on the Newborn 

Screening Family Education Program. 

The agenda for this meeting includes 

a potential vote which may lead to a 

decision to recommend a nominated 

condition (GAMT deficiency) to the 

RUSP. In addition, as noted in the 

agenda items, the Committee may hold 

a vote on whether or not to recommend 

a nominated condition (Krabbe disease) 

to full evidence-based review, which 

may lead to a recommendation to add or 

not add a condition/conditions to the 

RUSP at a future time. 

Agenda items are subject to change as 

priorities dictate. Information about the 

ACHDNC, including a roster of members 

and past meeting summaries, is also 

available on the ACHDNC website listed 

above. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may request to 

provide general oral comments and may 

submit written statements in advance of 

the scheduled meeting. Oral comments 

will be honored in the order they are 

requested and may be limited as time 

allows. Subject to change: Members of 

the public registered to submit oral 


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22540 Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Notices 

public comments on GAMT deficiency 

are tentatively scheduled to provide 

their statements on Thursday, May 12, 

2022. Members of the public registered 

to provide statements on all other 

newborn screening related topics are 

tentatively scheduled for Friday, May 

13, 2022. Requests to provide a written 

statement or make oral comments to the 

ACHDNC must be submitted via the 

registration website by 12:00 p.m. ET on 

Friday, May 6, 2022. 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Alaina 

Harris at the address and phone number 

listed above at least 10 business days 

prior to the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–08053 Filed 4–14–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Comments on Scientific 

Questions To Be Examined To Support 

the Development of the Dietary 

Guidelines for Americans, 2025–2030 

AGENCY: Department of Health and 

Human Services (HHS), Office of the 

Secretary, Office of the Assistant 

Secretary for Health, Office of Disease 

Prevention and Health Promotion; 

Department of Agriculture (USDA), 

Food, Nutrition, and Consumer 

Services. 

ACTION: Notice. 

SUMMARY: The Departments of Health 

and Human Services and Agriculture 

solicit written comments on the 

scientific questions to be examined in 

the review of evidence supporting the 

development of the Dietary Guidelines 

for Americans, 2025–2030. 

DATES: The scientific questions are 

available for review and public 

comment. Electronic or written/paper 

comments will be accepted through 

midnight Eastern Time on May 16, 

2022. 

ADDRESSES: The scientific questions are 

available on the internet at 

www.DietaryGuidelines.gov. Comments 

and attachments submitted 

electronically or by paper will be posted 

to the www.regulations.gov docket. You 

may submit comments as follows: 

• Electronic submissions: Follow the 

instructions for submitting comments at 

www.regulations.gov. 

• Written/paper submissions: Mail/ 

courier to Janet M. de Jesus, MS, RD, 

Office of Disease Prevention and Health 

Promotion (ODPHP) Office of the 

Assistant Secretary for Health (OASH), 

HHS; 1101 Wootton Parkway, Suite 420; 

Rockville, MD 20852. 

SUPPLEMENTARY INFORMATION: Section 

301 of the National Nutrition 

Monitoring and Related Research Act of 

1990 (7 U.S.C. 5341) requires the 

Secretaries of HHS and USDA to 

publish the Dietary Guidelines for 

Americans (Dietary Guidelines) jointly 

at least every five years. The most recent 

edition of the Dietary Guidelines (2020– 

2025) provided guidance on the entire 

life span, from birth to older adulthood, 

including pregnancy and lactation. The 

Dietary Guidelines for Americans, 2025– 

2030 will continue to address what to 

eat and drink across the entire lifespan 

to meet nutrient needs, promote health, 

and reduce the risk of chronic disease. 

The Departments are identifying 

scientific questions to be considered in 

the review of evidence to support the 

development of the Dietary Guidelines 

for Americans, 2025–2030. Given the 

prevalence of chronic diseases in the 

United States, scientific questions will 

continue to examine the relationship 

between diet and health outcomes, and 

a special emphasis will be placed on 

questions that address food-based 

strategies that can be used to help 

individuals implement the Dietary 

Guidelines and prevent or manage 

overweight and obesity. In establishing 

this list of scientific questions, the 

Departments are considering the 

following criteria for prioritization: 

relevance to the Dietary Guidelines, 

importance to public health, potential 

impact to federal programs, avoiding 

duplication with other federal efforts, 

and research availability. The list of 

questions, more information on the 

criteria for prioritization, and 

background on the process for 

developing the questions is available at 

www.dietaryguidelines.gov. 

• Electronic or Written Public 

Comments: Comments will be accepted 

through 11:59 p.m. Eastern Time May 

16, 2022 at www.regulations.gov. 

Comments received by mail/courier will 

be considered if they are postmarked on 

or before May 16, 2022. Written 

comments via mail/courier will be 

uploaded into www.regulations.gov and 

are under the same limitations as for 

those submitted electronically to 

www.regulations.gov: 5,000 (with 

spaces) character limit for text box, and 

a maximum number of ten attached files 

and maximum size (10 MB) of each 

attached file. Please make note of 

copyright issues on your attachments. A 

link to the www.regulations.gov 

electronic filing system will also be 

available at www.DietaryGuidelines.gov. 

HHS and USDA request comments on 

the list of scientific questions to be 

examined in the review of evidence 

supporting the development of the 

Dietary Guidelines for Americans, 2025– 

2030. Specifically, HHS and USDA 

request comments in support of or 

opposition to the proposed scientific 

questions. If a new scientific question is 

suggested, provide a brief summary of 

the topic, including information 

pertaining to the prioritization criteria 

listed above. It is requested that 

comments be limited to one page per 

topic. HHS and USDA will consider all 

relevant comments in finalizing the list 

of topics and questions to be examined 

in the development of the Dietary 

Guidelines, 2025–2030. 

Contact Person for Additional 

Information: Janet de Jesus, MS, RD, 

Nutrition Advisor, telephone 240–453– 

8266, Office of Disease Prevention and 

Health Promotion, U.S. Department of 

Health and Human Services, 

DietaryGuidelines@hhs.gov. 

Dated: April 11, 2022. 

Rachel L. Levine, 

Assistant Secretary for Health, U.S. Public 

Health Service. 

[FR Doc. 2022–08043 Filed 4–14–22; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel; Novel Synthetic NA Technology 

Development. 

Date: May 9, 2022. 

Time: 2:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


jspears on DSK121TN23PROD with NOTICES1