80 FR 29012 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 97 (May 20, 2015)

Page Range		29012-29013
FR Document		2015-12236

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.

Federal Register, Volume 80 Issue 97 (Wednesday, May 20, 2015)

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29012-29013]
From the Federal Register Online  [www.thefederalregister.org]
[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 
[email protected]. 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 [email protected].

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

29012 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

The Agency finds that reviewing such applicants (respondents) request is the estimated number of hours that a
information is critical to achieving a approximately 2,366 formal meetings respondent would spend preparing the
productive meeting. with CDER annually and approximately information package in accordance with
The collection of information 175 respondents request approximately the guidance, is estimated to be
described in the guidance reflects the 264 formal meetings with CBER approximately 18 hours. Based on
current and past practice of sponsors annually regarding the development and FDA’s experience, the Agency expects it
and applicants to submit meeting review of a PDUFA product. The hours will take respondents this amount of
requests as amendments to INDs, NDAs, per response, which is the estimated time to gather and copy brief statements
and BLAs and to submit background number of hours that a respondent about the product, a description of the
information prior to a scheduled would spend preparing the information details for the anticipated meeting, and
meeting. Agency regulations currently to be submitted with a meeting request data and information that generally
permit such requests and recommend in accordance with the guidance, is would already have been compiled for
the submission of an information estimated to be approximately 10 hours. submission to the Agency.
package before an end-of-phase 2 Based on FDA’s experience, the Agency As stated earlier, the guidance
meeting (§§ 312.47(b)(1)(ii) and expects it will take respondents this provides information on how the
(b)(1)(iv)) and a pre-NDA meeting amount of time to gather and copy brief Agency will interpret and apply section
(§ 312.47(b)(2)). statements about the product and a
Description of Respondents: A 119(a) of the FDAMA, specific PDUFA
description of the purpose and details of goals for the management of meetings
sponsor or applicant for a drug or the meeting.
biological product who requests a associated with the review of human
formal meeting with the Agency IV. Information Package drug applications for PDUFA products,
regarding the development and review and provisions of existing regulations
of a PDUFA product. Based on data collected from the describing certain meetings (§§ 312.47
Burden Estimate: Provided in this review divisions and offices within and 312.82). The information collection
document is an estimate of the annual CDER and CBER, FDA estimates that provisions in § 312.47 concerning end-
reporting burden for the submission of approximately 959 respondents of-phase 2 meetings and pre-NDA
meeting requests and information submitted approximately 1,901 meetings have been approved by OMB
packages under the guidance. information packages to CDER annually control number 0910–0014. However,
and approximately 142 respondents the guidance provides additional
III. Request for a Formal Meeting submitted approximately 193 recommendations for submitting
Based on data collected from the information packages to CBER annually information to FDA in support of a
review divisions and offices within prior to a formal meeting regarding the meeting request. As a result, FDA is
CDER and CBER, FDA estimates that development and review of a PDUFA submitting for OMB approval these
approximately 1,099 sponsors and product. The hours per response, which additional estimates.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Meeting requests and information packages responses per burden per Total hours
respondents responses
respondent response

Meeting Requests:
CDER ............................................................................ 1,099 2.15 2,366 10 23,660
CBER ............................................................................ 175 1.51 264 10 2,640
Total ....................................................................... ........................ ........................ ........................ ........................ 26,300
Information Packages:
CDER ............................................................................ 959 1.99 1,901 18 34,218
CBER ............................................................................ 142 1.36 193 18 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. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Leslie Kux, HUMAN SERVICES Administration (FDA) is announcing
Associate Commissioner for Policy. that a proposed collection of
Food and Drug Administration information has been submitted to the
[FR Doc. 2015–12170 Filed 5–19–15; 8:45 am]
Office of Management and Budget
BILLING CODE 4164–01–P
[Docket No. FDA–2008–N–0397] (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Agency Information Collection
Activities; Submission for Office of DATES: Fax written comments on the
mstockstill on DSK4VPTVN1PROD with NOTICES

Management and Budget Review; collection of information by June 19,
Comment Request; State Enforcement 2015.
Notifications ADDRESSES: To ensure that comments on
AGENCY: Food and Drug Administration, the information collection are received,
HHS. OMB recommends that written
comments be faxed to the Office of
ACTION: Notice.
Information and Regulatory Affairs,

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Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices 29013

OMB, Attn: FDA Desk Officer, FAX: has submitted the following proposed notification under § 100.2(d) enables us
202–395–7285, or emailed to oira_ collection of information to OMB for to identify the food against which a
submission@omb.eop.gov. All review and clearance. State intends to take action and to
comments should be identified with the advise that State whether Federal
State Enforcement Notifications—21
OMB control number 0910–0275. Also enforcement action against the food has
CFR 100.2(d)
include the FDA docket number found been taken or is in process. With certain
in brackets in the heading of this OMB Control Number 0910–0275— narrow exceptions, Federal enforcement
document. Extension action precludes State action under the
Section 310(b) of the Federal Food, FD&C Act.
FOR FURTHER INFORMATION CONTACT: FDA
Drug, and Cosmetic Act (the FD&C Act) In the Federal Register of March 13,
PRA Staff, Office of Operations, Food
(21 U.S.C. 337(b)) authorizes a State to 2015 (80 FR 13392), FDA published a
and Drug Administration, 8455
enforce certain sections of the FD&C Act 60-day notice requesting public
Colesville Rd.; COLE–14526, Silver
in their own name and within their own comment on the proposed collection of
Spring, MD 20993–0002 PRAStaff@
jurisdiction. However, before doing so, information. No comments were
fda.hhs.gov.
a State must provide notice to FDA received.
SUPPLEMENTARY INFORMATION: In according to 21 CFR 100.2. The We estimate the burden of this
compliance with 44 U.S.C. 3507, FDA information required in a letter of collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondents 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 provisions set forth in sections (Catalogue of Federal Domestic Assistance
§ 100.2(d) is minimal because 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program Nos. 93.853, Clinical Research
enforcement notifications are seldom as amended. The grant applications and Related to Neurological Disorders; 93.854,
used by States. During the last 3 years, the discussions could disclose Biological Basis Research in the
Neurosciences, National Institutes of Health,
we have not received any new confidential trade secrets or commercial HHS)
enforcement notifications; therefore, we property such as patentable material,
estimate that one or fewer notifications and personal information concerning Dated: May 14, 2015.
will be submitted annually. Although individuals associated with the grant Carolyn Baum,
we have not received any new applications, the disclosure of which Program Analyst, Office of Federal Advisory
enforcement notifications in the last 3 would constitute a clearly unwarranted Committee Policy.
years, we believe these information invasion of personal privacy. [FR Doc. 2015–12125 Filed 5–19–15; 8:45 am]
collection provisions should be Name of Committee: National Institute of BILLING CODE 4140–01–P
extended to provide for the potential Neurological Disorders and Stroke, Initial
future need of a State government to Review Group, Neurological Sciences and
submit enforcement notifications Disorders B. DEPARTMENT OF HEALTH AND
informing us when it intends to take Date: June 25–26, 2015. HUMAN SERVICES
enforcement action under the FD&C Act Time: 8:00 a.m. to 6:00 p.m.
against a particular food located in the Agenda: To review and evaluate grant National Institutes of Health
applications.
State. Place: Wyndam Grand Chicago Riverfront Center for Scientific Review; Notice of
Dated: May 15, 2015. Hotel, 71 E. Wacker Drive, Chicago, IL 60601. Closed Meetings
Leslie Kux, Contact Person: Birgit Neuhuber, Ph.D.,
Scientific Review Officer, Scientific Review Pursuant to section 10(d) of the
Associate Commissioner for Policy.
Branch, Division of Extramural Research,
[FR Doc. 2015–12236 Filed 5–19–15; 8:45 am] NINDS/NIH/DHHS/Neuroscience Center,
Federal Advisory Committee Act, as
BILLING CODE 4164–01–P 6001 Executive Boulevard, Suite 3208, MSC amended (5 U.S.C. App.), notice is
9529, Bethesda, MD 20892–9529, 301–496– hereby given of the following meetings.
3562, neuhuber@ninds.nih.gov. The meetings will be closed to the
DEPARTMENT OF HEALTH AND Name of Committee: Neurological Sciences public in accordance with the
HUMAN SERVICES Training Initial Review Group, NST–2 provisions set forth in sections
Subcommittee. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Institutes of Health Date: June 29–30, 2015.
Time: 8:00 a.m. to 4:00 p.m.
as amended. The grant applications and
National Institute of Neurological Agenda: To review and evaluate grant the discussions could disclose
Disorders and Stroke; Notice of Closed applications. confidential trade secrets or commercial
Place: The Fairmont Washington, DC, 2401 property such as patentable material,
mstockstill on DSK4VPTVN1PROD with NOTICES

Meetings
M Street NW., Washington, DC 20037. and personal information concerning
Pursuant to section 10(d) of the Contact Person: Elizabeth A. Webber, individuals associated with the grant
Federal Advisory Committee Act, as Ph.D., Scientific Review Officer, Scientific applications, the disclosure of which
Review Branch, Division of Extramural would constitute a clearly unwarranted
amended (5 U.S.C. App.), notice is Research, NINDS/NIH/DHHS/Neuroscience
hereby given of the following meetings. Center, 6001 Executive Boulevard, Suite
invasion of personal privacy.
The meetings will be closed to the 3208, MSC 9529, Bethesda, MD 20892–9529, Name of Committee: Oncology 2—
public in accordance with the 301–496–1917, webbere@mail.nih.gov. Translational Clinical Integrated Review

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Document Created: 2018-02-21 10:30:01
Document Modified: 2018-02-21 10:30:01

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
Action		Notice.
Dates		Fax written comments on the collection of information by June 19, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002 [email protected]
FR Citation		80 FR 29012

80 FR 29012 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 97 (May 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration