81 FR 51205 - Delegation of Authorities

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 81, Issue 149 (August 3, 2016)

Page Range		51205-51205
FR Document		2016-18417

Federal Register, Volume 81 Issue 149 (Wednesday, August 3, 2016)

[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Page 51205]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Delegation of Authorities

    Notice is hereby given that I have delegated to the Commissioner of 
Food and Drugs (the Commissioner) those authorities vested in the 
Secretary of the Department of Health and Human Services under sections 
1002; 1003; 1004; 1005(f); and 1006(b) and (d) of the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), which relate to 
the functions of the Food and Drug Administration.
    This authority may be re-delegated. This delegation will be 
exercised in accordance with the Department of Health and Human 
Services' applicable policies, procedures, guidelines, and regulations.
    I ratify and affirm any actions taken by the Commissioner or the 
Commissioner's subordinates that involved the exercise of the authority 
delegated herein prior to the effective date of this delegation. This 
delegation was effective on November 17, 2015.

    Dated: July 27, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016-18417 Filed 8-2-16; 8:45 am]
 BILLING CODE P

Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices 51205

imposed by this regulation. The written and maintaining the records required comment on the proposed collection of
agreement generally also includes under the third-party disclosure section information. No comments were
contractual agreements that are a usual of this collection. received.
and customary business practice. The In the Federal Register of April 20, FDA estimates the burden of this
recordkeeping requirements of 2016 (81 FR 23309), FDA published a collection of information as follows:
§ 801.150(a)(2) consist of making copies 60-day notice requesting public

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Average
Number of
Number of Total annual burden per
21 CFR section records per Total hours
recordkeepers records recordkeeping
recordkeeper (hours)

Record retention, 801.150(a)(2) .......................................... 90 20 1,800 .5 900

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of Average
Number of disclosures Total annual burden per
Activity/21 CFR section Total hours
respondents per disclosures disclosure
respondent (hours)

Agreement and labeling requirements, 801.150(e) ............. 90 20 1,800 4 7,200

Dated: July 28, 2016. DEPARTMENT OF HEALTH AND and Transplantation Research; 93.856,
Leslie Kux, HUMAN SERVICES Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Associate Commissioner for Policy.
[FR Doc. 2016–18299 Filed 8–2–16; 8:45 am] National Institutes of Health Dated: July 28, 2016.
BILLING CODE 4164–01–P Melanie J. Gray,
National Institute of Allergy and
Program Analyst, Office of Federal Advisory
Infectious Diseases; Notice of Closed
Committee Policy.
Meeting
DEPARTMENT OF HEALTH AND [FR Doc. 2016–18391 Filed 8–2–16; 8:45 am]
HUMAN SERVICES Pursuant to section 10(d) of the BILLING CODE 4140–01–P
Federal Advisory Committee Act, as
Office of the Secretary amended (5 U.S.C. App.), notice is
hereby given of the following meeting. DEPARTMENT OF HEALTH AND
Delegation of Authorities The meeting will be closed to the HUMAN SERVICES
Notice is hereby given that I have public in accordance with the
provisions set forth in sections Substance Abuse and Mental Health
delegated to the Commissioner of Food
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Services Administration
and Drugs (the Commissioner) those
authorities vested in the Secretary of the as amended. The grant applications and [Docket No. SAMHSA–2016–0002]
Department of Health and Human the discussions could disclose
Services under sections 1002; 1003; confidential trade secrets or commercial Request for Comment on Report
1004; 1005(f); and 1006(b) and (d) of the property such as patentable material, Entitled: Advancing the Care of
Food and Drug Administration and personal information concerning Pregnant and Parenting Women With
Amendments Act of 2007 (Pub. L. 110– individuals associated with the grant Opioid Use Disorder and Their Infants:
85), which relate to the functions of the applications, the disclosure of which A Foundation for Clinical Guidance
Food and Drug Administration. would constitute a clearly unwarranted
invasion of personal privacy. AGENCY: Substance Abuse and Mental
This authority may be re-delegated. Health Services Administration
This delegation will be exercised in Name of Committee: National Institute of (SAMHSA), Department of Health and
accordance with the Department of Allergy and Infectious Diseases Special
Emphasis Panel; NIAID SBIR Phase II Human Services (HHS).
Health and Human Services’ applicable Clinical Trial Implementation (U44). ACTION: Request for comment.
policies, procedures, guidelines, and Date: August 30, 2016.
regulations. Time: 1:00 p.m. to 3:00 p.m. SUMMARY: SAMHSA, Center for
I ratify and affirm any actions taken Agenda: To review and evaluate grant Substance Abuse Treatment (CSAT), in
by the Commissioner or the applications. HHS announces the opening of a docket
Commissioner’s subordinates that Place: National Institutes of Health, 3F100, to obtain public comment on a report
5601 Fishers Lane, Rockville, MD 20892, entitled: Advancing the Care of Pregnant
involved the exercise of the authority (Telephone Conference Call). and Parenting Women with Opioid Use
asabaliauskas on DSK3SPTVN1PROD with NOTICES

delegated herein prior to the effective Contact Person: Lynn Rust, Ph.D.,
date of this delegation. This delegation Scientific Review Officer, Scientific Review Disorder and their Infants: A
was effective on November 17, 2015. Program, Division of Extramural Activities, Foundation for Clinical Guidance.
Room 3G42A, National Institutes of Health/ This report describes the formal
Dated: July 27, 2016. process agreed on and followed under
NIAID, 5601 Fishers Lane, MSC 9823,
Sylvia M. Burwell, Bethesda, MD 20892–9823, (240) 669–5069, the guidance of the federal steering
Secretary. lrust@niaid.nih.gov. committee (FSC). It explains the RAND
[FR Doc. 2016–18417 Filed 8–2–16; 8:45 am] (Catalogue of Federal Domestic Assistance Corporation (RAND)/University of
BILLING CODE P Program Nos. 93.855, Allergy, Immunology, California Los Angeles (UCLA)

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Document Created: 2016-08-02 23:43:49
Document Modified: 2016-08-02 23:43:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 51205

81 FR 51205 - Delegation of Authorities

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 81, Issue 149 (August 3, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary