Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10107 

The DUA legally binds the user to the 

Agreement’s terms. The user must agree 

to all the terms and sign off on them 

prior to the release or access to data files 

containing protected health information, 

and individual identifiers. The DMP 

SAQ is a technical, evidence-based 

questionnaire that DUA users must 

complete as part of the data request 

packet. The DMP SAQ will enable CMS 

to evaluate researcher data systems to 

ensure that CMS data are adequately 

secured and appropriately protected, as 

per the Privacy Act and the HIPAA 

Privacy Rule. The DMP SAQ also allows 

CMS to measure compliance through 

the implementation of security and 

privacy controls as outlined in the 

National Institute of Standards and 

Technology (NIST) Special Publication 

800–53 and the Centers for Medicare & 

Medicaid Services (CMS) Information 

Security and Acceptable Risk 

Safeguards (ARS). The second 

component of the DMP SAQ is to 

provide ongoing oversight. All 

organizations will be subject to routine 

audits of the environments used to store 

and process CMS data, as described in 

their organizational-level DMP SAQ. 

Form Number: CMS–10733 (OMB 

control number: 0938-New); Frequency: 

Annually; Affected Public: Private 

Sector, State, Local, or Tribal 

Governments, Federal Government, 

Business or other for-profits, Not-forprofits institutions; Number of 

Respondents: 1,000; Total Annual 

Responses: 1,000; Total Annual Hours: 

1,500. (For policy questions regarding 

this collection contact James Krometis at 

410–786–0340.) 

Dated: February 12, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–03260 Filed 2–17–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–N–1027, FDA– 

2017–N–1064, FDA–2009–N–0380, FDA– 

2010–N–0588, FDA–2014–N–0487, and FDA– 

2013–N–1429] 

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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved 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 

Infant Formula Recall Regulations .......................................................................................................................... 0910–0188 12/31/2023 

State Petitions for Exemption from Preemption ...................................................................................................... 0910–0277 12/31/2023 

Product Jurisdiction and Combination Products ..................................................................................................... 0910–0523 12/31/2023 

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile ...... 0910–0614 12/31/2023 

Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery ........................................................................................................................................................................ 0910–0697 12/31/2023 

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FFDCA and Associated Fees Under Section 744K ..................................................................................................................... 0910–0776 12/31/2023 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03254 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Treatment; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Treatment 

(CSAT) National Advisory Council 

(NAC) will meet on March 31, 2021, 

1:00 p.m.–6:00 p.m. (EDT). 

The meeting is open to the public and 

will include consideration of minutes 

from the SAMHSA CSAT NAC meeting 

of September 22, 2020; an update on 

CSAT activities; a discussion with 

SAMHSA leadership; a discussion about 

the use of technology in prevention and 

treatment of substance use disorders; 

and a discussion on rural and frontier 

communities. 

The meeting will be held via WebEx 

and telephone only. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the Council. Oral presentations 

from the public will be scheduled at the 

conclusion of the meeting. Individuals 

interested in making oral presentations 

or written submissions must notify the 

contact person on or before March 19, 

2021. Up to five minutes will be allotted 

for each presentation. 

Registration is required to participate. 

To attend virtually, or to obtain the callin number and access code, submit 

written or brief oral comments, or 

request special accommodations for 

persons with disabilities, please register 

on-line at http://snacregister.

samhsa.gov/MeetingList.aspx, or 

communicate with the CSAT National 

Advisory Council Designated Federal 

Officer; (see contact information below). 

Meeting information and a roster of 

Council members may be obtained by 

accessing the SAMHSA Committee 


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