36334 Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 

21 CFR part or guidance Topic OMB control 

No. 

814, subparts A through E ........................................................................................... Premarket approval .................................. 0910–0231 

814, subpart H .............................................................................................................. Humanitarian Device Exemption .............. 0910–0332 

812 ................................................................................................................................ Investigational Device Exemption ............. 0910–0078 

‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ ... De Novo classification process ................ 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program and Meetings with Food and Drug Administration Staff’’.Q-submissions; pre-submissions .............. 0910–0756 

800, 801, and 809 ........................................................................................................ Medical Device Labeling Regulations ...... 0910–0485 

Dated: June 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12930 Filed 6–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0955–0020] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before August 15, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0955–0020–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: United States 

Core Data for Interoperability New Data 

Element. 

Type of Collection: Revision. 

OMB No.: 0955–0020—Office of the 

National Coordinator for Health 

Information Technology—Specific 

program collecting the data (is 

applicable). 

Abstract: The Office of the National 

Coordinator for Health Information 

Technology is seeking the revision on a 

previously approved by OMB #0955– 

0020 information collection request 

item ‘‘United States Core Data for 

Interoperability (USCDI) New Data 

Element Submission Form.’’ The USCDI 

is a standardized set of health data 

classes and constituent data elements 

used to support nationwide, 

interoperable health information 

exchange. The USCDI Version 1 is the 

required standard data elements set to 

which all health IT developers must 

conform to obtain ONC certification. 

This certification is required for 

participation in some federal healthcare 

payment plans. In order to ensure the 

USCDI remains current and reflects the 

needs of the health IT community, ONC 

has established a predictable, 

transparent, and collaborative process to 

solicit broad stakeholder input to 

expand the USCDI. Anyone, including 

ONC staff, staff from other federal 

agencies, and other stakeholders may 

submit proposals for new data elements 

and classes. ONC will evaluate each 

submission and provide feedback to the 

submitter. ONC will draft a new version 

of the USCDI based on these 

submissions and this draft will undergo 

review by ONC’s federal advisory 

committee, the Health Information 

Technology Advisory Committee 

(HITAC), as well as by the general 

public. Upon approval by the National 

Coordinator for Health Information 

Technology, new data classes and data 

elements from these submissions will be 

added to the newest version of the 

USCDI standard for integration into 

health information technology products 

such as electronic health records. ONC 

is seeking approval to continue to 

collect this information from health IT 

stakeholders. 

Need and Proposed Use of the 

Information: The information collected 

from this submission system is needed 

as it will comprise the sum total of the 

items ONC will evaluate for addition to 

the next version of the USCDI. The 

requested data will provide supporting 

documentation to justify addition of the 

data elements to the USCDI, and, if the 

documentation does justify addition to 

the USCDI, to one of several levels of 

candidate data elements for future 

development and consideration. The 

requested data and ONC’s evaluation of 

the data will be publicly available for 

review at any time to provide 

transparency and predictability in the 

USCDI expansion process. It will 

contain information about the submitter 

to allow ONC to provide direct feedback 

to submitters on ONC’s evaluation of 

such submission. 

Likely Respondents: Likely 

respondents to this new submission 

system will be various health IT 

stakeholders including health care 

providers, standards development 

organizations, health IT developers and 

vendors as well as members of the 

HITAC. 

The total annual burden hours 

estimated for this ICR are summarized 

in the table below. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

USCDI Submission .............................................................. ........................ 200 1 20/60 67 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 116 / Thursday, June 16, 2022 / Notices 36335 

ANNUALIZED BURDEN HOUR TABLE—Continued 

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Total .............................................................................. ........................ 200 ........................ ........................ 67 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–12958 Filed 6–15–22; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 Institute on 

Drug Abuse Special Emphasis Panel; 

Mechanism for Time-Sensitive Drug Abuse 

Research (R21 Clinical Trial Optional). 

Date: July 25, 2022. 

Time: 2:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Soyoun Cho, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

National Institute on Drug Abuse, NIH, 301 

North Stonestreet Avenue, MSC, 6021, 

Bethesda, MD 20892, (301) 594–9460, 

Soyoun.cho@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: June 10, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12950 Filed 6–15–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 Institute of 

Environmental Health Sciences Special 

Emphasis Panel: Review of the NIH Pathway 

to Independence Award (K99/R00) 

Applications. 

Date: July 7, 2022. 

Time: 10:30 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Environmental 

Health Sciences, Keystone Building, 530 

Davis Drive, Durham, NC 27709 (Virtual 

Meeting). 

Contact Person: Qingdi Quentin Li, MD, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat’l Institute 

Environmental Health Sciences, Research 

Triangle Park, NC 27709, (240) 858–3914, 

liquenti@nih.gov. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel: Review of the Transition to 

Independent Environmental Health Research 

Career Award (K01/K08) Applications. 

Date: July 8, 2022. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Environmental 

Health Sciences, Keystone Building, 530 

Davis Drive, Durham, NC 27709 (Virtual 

Meeting). 

Contact Person: Qingdi Quentin Li, MD, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat’l Institute 

Environmental Health Sciences, Research 

Triangle Park, NC 27709, (240) 858–3914, 

liquenti@nih.gov. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel: Review of the Outstanding 

New Environmental Scientist Program. 

Date: July 26, 2022. 

Time: 10:30 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Environmental 

Health Sciences, Keystone Building, 530 

Davis Drive, Durham, NC 27709 (Virtual 

Meeting). 

Contact Person: Leroy Worth, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research and 

Training, Nat. Institute of Environmental 

Health Sciences, P.O. Box 12233, MD EC–30/ 

Room 3171, Research Triangle Park, NC 

27709, 984–287–3340, worth@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: June 10, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12925 Filed 6–15–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 


khammond on DSKJM1Z7X2PROD with NOTICES