Office of Medical Products and Tobacco; Center for Drug Evaluation and Research; Statement of Organization, Functions, and Delegations of Authority, 24822 [2016-09761]

Download as PDF 24822 Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Total operating and maintenance costs Request for CLIA Categorization ............. 60 15 900 1 900 $46,800 1 There are no capital costs associated with this collection of information. The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour (52 × 900), totaling $46,800. This includes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. The burden hours are based on FDA familiarity with the types of documentation typically included in a sponsor’s categorization requests, and costs for basic office supplies (e.g., paper). Dated: April 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–09769 Filed 4–26–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Office of Medical Products and Tobacco; Center for Drug Evaluation and Research; Statement of Organization, Functions, and Delegations of Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Medical Policy has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services on December 15, 2016, and effective on April 17, 2016. FOR FURTHER INFORMATION CONTACT: Melanie Keller, Office of Management, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, Food and Drug asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:29 Apr 26, 2016 Jkt 238001 Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 301– 796–3291. Dated: April 19, 2016. Sylvia M. Burwell, Secretary of Health and Human Services. I. Summary This organization will expand current activities in the Office of Medical Policy and foster efficient oversight of clinical trials conducted through policy initiatives that build quality upfront and science-based inspectional approaches. This will provide an oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to improve science and efficiency trials. The Food and Drug Administration, Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Medical Policy has been restructured as follows: DKKNF. ORGANIZATION. The Office of Medical Policy is headed by the Director, Office of Medical Policy and includes the following organizational units: Office of Medical Policy Office of Prescription Drug Promotion Division of Advertising and Promotion Review I Division of Advertising and Promotion Review II [FR Doc. 2016–09761 Filed 4–26–16; 8:45 am] II. Delegations of Authority Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization. III. Electronic Access This reorganization is reflected in FDA’s Staff Manual Guides (SMG). Persons interested in seeing the complete Staff Manual Guide can find it on FDA’s Web site at: https:// www.fda.gov/AboutFDA/ ReportsManualsForms/ StaffManualGuides/default.htm. Authority: 44 U.S.C. 3101. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than June 27, 2016. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N39, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the SUMMARY: E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Page 24822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Office of Medical Products and Tobacco; Center for Drug 
Evaluation and Research; Statement of Organization, Functions, and 
Delegations of Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA), Office of Medical 
Products and Tobacco, Center for Drug Evaluation and Research, Office 
of Medical Policy has modified its structure. This new organizational 
structure was approved by the Secretary of Health and Human Services on 
December 15, 2016, and effective on April 17, 2016.

FOR FURTHER INFORMATION CONTACT: Melanie Keller, Office of Management, 
Center for Drug Evaluation and Research, Office of Medical Products and 
Tobacco, Food and Drug Administration, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, 301-796-3291.

I. Summary

    This organization will expand current activities in the Office of 
Medical Policy and foster efficient oversight of clinical trials 
conducted through policy initiatives that build quality upfront and 
science-based inspectional approaches. This will provide an oversight 
and direction for new and ongoing policy initiatives in broad-based 
medical and clinical policy areas, including initiatives to improve 
science and efficiency trials.
    The Food and Drug Administration, Office of Medical Products and 
Tobacco, Center for Drug Evaluation and Research, Office of Medical 
Policy has been restructured as follows:
    DKKNF. ORGANIZATION. The Office of Medical Policy is headed by the 
Director, Office of Medical Policy and includes the following 
organizational units:

Office of Medical Policy
Office of Prescription Drug Promotion
Division of Advertising and Promotion Review I
Division of Advertising and Promotion Review II

II. Delegations of Authority

    Pending further delegation, directives, or orders by the 
Commissioner of Food and Drugs, all delegations and redelegations of 
authority made to officials and employees of affected organizational 
components will continue in them or their successors pending further 
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    This reorganization is reflected in FDA's Staff Manual Guides 
(SMG). Persons interested in seeing the complete Staff Manual Guide can 
find it on FDA's Web site at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

    Authority:  44 U.S.C. 3101.

    Dated: April 19, 2016.
Sylvia M. Burwell,
Secretary of Health and Human Services.
[FR Doc. 2016-09761 Filed 4-26-16; 8:45 am]
 BILLING CODE P
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