Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications, 61223 [2016-21228]

Download as PDF Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices in brackets in the heading of this document. DEPARTMENT OF HEALTH AND HUMAN SERVICES FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration [Docket No. FDA–2009–N–0380] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 6, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0523. Also include the FDA docket number found SUMMARY: Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications—21 CFR Part 3—OMB Control Number 0910–0523— Extension This regulation relates to Agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Pub. L. 101–629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107– 250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of: (1) A drug and a device; (2) a device and a biological product; (3) a biological product and a drug; or (4) a drug, a device, and a biological product. 61223 The second purpose of this regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant’s recommendation as to which Agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biological products, and combination products. The respondents will be businesses or other for-profit organizations. In the Federal Register of January 28, 2016 (81 FR4921), FDA published a 60day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR part Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 3 ........................................................................................... 84 1 84 24 2,016 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These burden estimates are based on the number of applications FDA received over the past fiscal year. Dated: August 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21228 Filed 9–2–16; 8:45 am] mstockstill on DSK3G9T082PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Senior Executive Service Performance Review Board Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In this notice, the Health Resources and Services Administration (HRSA) located within the Department of Health and Human Services (HHS) publishes a list of persons who may be named to serve on the Performance SUMMARY: VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA. FOR FURTHER INFORMATION CONTACT: Dora Ober, Executive Resources, Office of Human Resources, 5600 Fishers Lane, Rm 12N06C, Rockville, Maryland 20857, Telephone (301) 443–0759. SUPPLEMENTARY INFORMATION: Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95–454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons may be named to serve on the HRSA Performance Review Board, which will oversee the evaluation of performance appraisals of E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Page 61223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21228]



[[Page 61223]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Product Jurisdiction: 
Assignment of Agency Component for Review of Premarket Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
6, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0523. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Product Jurisdiction: Assignment of Agency Component for Review of 
Premarket Applications--21 CFR Part 3--OMB Control Number 0910-0523--
Extension

    This regulation relates to Agency management and organization and 
has two purposes. The first is to implement section 503(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by 
the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by 
the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-
250), by specifying how FDA will determine the organizational component 
within FDA assigned to have primary jurisdiction for the premarket 
review and regulation of products that are comprised of any combination 
of: (1) A drug and a device; (2) a device and a biological product; (3) 
a biological product and a drug; or (4) a drug, a device, and a 
biological product.
    The second purpose of this regulation is to enhance the efficiency 
of Agency management and operations by providing procedures for 
classifying and determining which Agency component is designated to 
have primary jurisdiction for any drug, device, or biological product 
where such jurisdiction is unclear or in dispute.
    The regulation establishes a procedure by which an applicant may 
obtain an assignment or designation determination. The regulation 
requires that the request include the identity of the applicant, a 
comprehensive description of the product and its proposed use, and the 
applicant's recommendation as to which Agency component should have 
primary jurisdiction, with an accompanying statement of reasons. The 
information submitted would be used by FDA as the basis for making the 
assignment or designation decision. Most information required by the 
regulation is already required for premarket applications affecting 
drugs, devices, biological products, and combination products. The 
respondents will be businesses or other for-profit organizations.
    In the Federal Register of January 28, 2016 (81 FR4921), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                            21 CFR part                                 Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3..................................................................              84                1               84               24            2,016
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These burden estimates are based on the number of applications FDA 
received over the past fiscal year.

    Dated: August 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21228 Filed 9-2-16; 8:45 am]
BILLING CODE 4164-01-P