Federal Register - February 18, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices The DUA legally binds the user to the Agreements 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 80053 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: CMS10733 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 4107860340.
Dated: February 12, 2021.
William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
FR Doc. 202103260 Filed 21721; 8:45 am BILLING CODE 412001P
Notice.
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, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket Nos. FDA2014N1027, FDA
2017N1064, FDA2009N0380, FDA
2010N0588, FDA2014N0487, and FDA
2013N1429
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY:
ACTION:
Food and Drug Administration,
HHS.
TABLE 1LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control No.
Title of collection Infant Formula Recall Regulations
State Petitions for Exemption from Preemption
Product Jurisdiction and Combination Products
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery
Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FFDCA and Associated Fees Under Section 744K
Dated: February 11, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202103254 Filed 21721; 8:45 am BILLING CODE 416401P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment; Notice of Meeting Pursuant to Public Law 92463, notice is hereby given that the Substance Abuse and Mental Health Services Administrations SAMHSA
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17:47 Feb 17, 2021
Jkt 253001
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
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Date approval expires
09100188
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09100523
09100614
12/31/2023
12/31/2023
12/31/2023
12/31/2023
09100697
12/31/2023
09100776
12/31/2023
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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