Agency Information Collection Activities: Submission for OMB Review; Comment Request, 10106-10107 [2021-03260]

Download as PDF 10106 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices Dated: February 11, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–03243 Filed 2–17–21; 8:45 am] BILLING CODE 4164–01–P Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2021–03232 Filed 2–17–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention jbell on DSKJLSW7X2PROD with NOTICES 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, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92–463. 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: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)— SIP21–007, Epilepsy Incidence and Etiology: Important Information for Public Health Prevention and Health Promotion in the US Community. Date: May 11, 2021. Time: 11:00 a.m.–6:00 p.m., EDT. Place: Teleconference. Agenda: To review and evaluate grant applications. For Further Information Contact: Jaya Raman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop S107–8, Atlanta, Georgia 30341, Telephone (770) 488–6511, JRaman@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and VerDate Sep<11>2014 17:47 Feb 17, 2021 Jkt 253001 To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ website address at website address at: https:// www.cms.gov/Regulations-andGuidance/Legislation/ PaperworkReductionActof1995/PRAListing.html DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Centers for Medicare & Medicaid Services SUPPLEMENTARY INFORMATION: [Document Identifier: CMS–10733] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. SUMMARY: Comments on the collection(s) of information must be received by the OMB desk officer by March 22, 2021. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. DATES: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 William Parham at (410) 786–4669. Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Data Management Plan Self-Attestation Questionnaire (DMP SAQ); Use: The Privacy Act of 1974 allows for discretionary releases of data maintained in Privacy Act protected systems of records under § 552a(b) (Conditions of Disclosure). The mandate to account for disclosures of data under the Privacy Act is found at § 552a(c)(Accounting of Certain Disclosures). This section states that certain information must be maintained regarding disclosures made by each agency. This information is: Date, Nature, Purpose, and Name/Address of Recipient. Section 552a(e) sets the overall Agency Requirements that each agency must meet in order to maintain records under the Privacy Act. The Data Use Agreement (DUA) form is needed as part of the review of each CMS data request to ensure compliance with the requirements of the Privacy Act for disclosures that contain PII. E:\FR\FM\18FEN1.SGM 18FEN1 10107 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 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 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, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, 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. 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: ACTION: Food and Drug Administration, HHS. TABLE 1—LIST 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. 2021–03254 Filed 2–17–21; 8:45 am] BILLING CODE 4164–01–P 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 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration’s (SAMHSA) VerDate Sep<11>2014 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Date approval expires 0910–0188 0910–0277 0910–0523 0910–0614 12/31/2023 12/31/2023 12/31/2023 12/31/2023 0910–0697 12/31/2023 0910–0776 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 https://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 E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10106-10107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10733]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by March 22, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Data 
Management Plan Self-Attestation Questionnaire (DMP SAQ); Use: The 
Privacy Act of 1974 allows for discretionary releases of data 
maintained in Privacy Act protected systems of records under Sec.  
552a(b) (Conditions of Disclosure). The mandate to account for 
disclosures of data under the Privacy Act is found at Sec.  
552a(c)(Accounting of Certain Disclosures). This section states that 
certain information must be maintained regarding disclosures made by 
each agency. This information is: Date, Nature, Purpose, and Name/
Address of Recipient. Section 552a(e) sets the overall Agency 
Requirements that each agency must meet in order to maintain records 
under the Privacy Act. The Data Use Agreement (DUA) form is needed as 
part of the review of each CMS data request to ensure compliance with 
the requirements of the Privacy Act for disclosures that contain PII.

[[Page 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-for-profits 
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

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