Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 29012-29013 [2015-12236]

Download as PDF 29012 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices The Agency finds that reviewing such information is critical to achieving a productive meeting. The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests as amendments to INDs, NDAs, and BLAs and to submit background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an end-of-phase 2 meeting (§§ 312.47(b)(1)(ii) and (b)(1)(iv)) and a pre-NDA meeting (§ 312.47(b)(2)). Description of Respondents: A sponsor or applicant for a drug or biological product who requests a formal meeting with the Agency regarding the development and review of a PDUFA product. Burden Estimate: Provided in this document is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance. III. Request for a Formal Meeting Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 1,099 sponsors and applicants (respondents) request approximately 2,366 formal meetings with CDER annually and approximately 175 respondents request approximately 264 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 10 hours. Based on FDA’s experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting. IV. Information Package Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 959 respondents submitted approximately 1,901 information packages to CDER annually and approximately 142 respondents submitted approximately 193 information packages to CBER annually prior to a formal meeting regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the guidance, is estimated to be approximately 18 hours. Based on FDA’s experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the Agency. As stated earlier, the guidance provides information on how the Agency will interpret and apply section 119(a) of the FDAMA, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82). The information collection provisions in § 312.47 concerning endof-phase 2 meetings and pre-NDA meetings have been approved by OMB control number 0910–0014. However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting for OMB approval these additional estimates. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Meeting requests and information packages Meeting Requests: CDER ............................................................................ CBER ............................................................................ Number of responses per respondent Average burden per response Total annual responses Total hours 1,099 175 2.15 1.51 2,366 264 10 10 23,660 2,640 Total ....................................................................... Information Packages: CDER ............................................................................ CBER ............................................................................ ........................ ........................ ........................ ........................ 26,300 959 142 1.99 1.36 1,901 193 18 18 34,218 3,474 Total ....................................................................... ........................ ........................ ........................ ........................ 37,692 Grand Total .................................................... ........................ ........................ ........................ ........................ 63,992 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 14, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12170 Filed 5–19–15; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0397] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 PO 00000 Notice. Frm 00084 Fmt 4703 Sfmt 4703 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. SUMMARY: Fax written comments on the collection of information by June 19, 2015. DATES: 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, ADDRESSES: E:\FR\FM\20MYN1.SGM 20MYN1 29013 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices 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 0910–0275. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE–14526, Silver Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA SUPPLEMENTARY INFORMATION: has submitted the following proposed collection of information to OMB for review and clearance. State Enforcement Notifications—21 CFR 100.2(d) OMB Control Number 0910–0275— Extension Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain sections of the FD&C Act in their own name and within their own jurisdiction. However, before doing so, a State must provide notice to FDA according to 21 CFR 100.2. The information required in a letter of notification under § 100.2(d) enables us to identify the food against which a State intends to take action and to advise that State whether Federal enforcement action against the food has been taken or is in process. With certain narrow exceptions, Federal enforcement action precludes State action under the FD&C Act. In the Federal Register of March 13, 2015 (80 FR 13392), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondents Total annual responses Average burden per response Total hours 100.2(d) ................................................................................ 1 1 1 10 10 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated reporting burden for § 100.2(d) is minimal because enforcement notifications are seldom used by States. During the last 3 years, we have not received any new enforcement notifications; therefore, we estimate that one or fewer notifications will be submitted annually. Although we have not received any new enforcement notifications in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing us when it intends to take enforcement action under the FD&C Act against a particular food located in the State. Dated: May 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12236 Filed 5–19–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. 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: National Institute of Neurological Disorders and Stroke, Initial Review Group, Neurological Sciences and Disorders B. Date: June 25–26, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Wyndam Grand Chicago Riverfront Hotel, 71 E. Wacker Drive, Chicago, IL 60601. Contact Person: Birgit Neuhuber, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496– 3562, neuhuber@ninds.nih.gov. Name of Committee: Neurological Sciences Training Initial Review Group, NST–2 Subcommittee. Date: June 29–30, 2015. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037. Contact Person: Elizabeth A. Webber, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496–1917, webbere@mail.nih.gov. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: May 14, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–12125 Filed 5–19–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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. 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: Oncology 2— Translational Clinical Integrated Review E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29012-29013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0397]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; State Enforcement 
Notifications

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 June 
19, 2015.

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,

[[Page 29013]]

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 0910-0275. 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, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002 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.

State Enforcement Notifications--21 CFR 100.2(d)

OMB Control Number 0910-0275--Extension

    Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain 
sections of the FD&C Act in their own name and within their own 
jurisdiction. However, before doing so, a State must provide notice to 
FDA according to 21 CFR 100.2. The information required in a letter of 
notification under Sec.  100.2(d) enables us to identify the food 
against which a State intends to take action and to advise that State 
whether Federal enforcement action against the food has been taken or 
is in process. With certain narrow exceptions, Federal enforcement 
action precludes State action under the FD&C Act.
    In the Federal Register of March 13, 2015 (80 FR 13392), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents      respondents       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d)...........................................................               1                1                1               10               10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated reporting burden for Sec.  100.2(d) is minimal 
because enforcement notifications are seldom used by States. During the 
last 3 years, we have not received any new enforcement notifications; 
therefore, we estimate that one or fewer notifications will be 
submitted annually. Although we have not received any new enforcement 
notifications in the last 3 years, we believe these information 
collection provisions should be extended to provide for the potential 
future need of a State government to submit enforcement notifications 
informing us when it intends to take enforcement action under the FD&C 
Act against a particular food located in the State.

    Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12236 Filed 5-19-15; 8:45 am]
BILLING CODE 4164-01-P
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