<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="Document">
<META name="creation-date" content="16/12/2008 10:09:40 ">
<TITLE>Document</TITLE>

76364
Federal Register/Vol. 73, No. 242 /Tuesday, December 16, 2008 /Notices
that require FDA to reevaluate safety
and/or effectiveness data. The goal of
this guidance is to create greater
consistency in how such applications
are handled by sponsors and by FDA’s
Center for Veterinary Medicine (CVM).
DATES:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 17, 2009.
ADDRESSES:
Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-
addressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION
section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8105, e-
mail<EMAIL_ADDRESS>SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry
#
191
entitled ‘‘Changes to Approved
NADAs—New NADAs vs. Category II
Supplemental NADAs’’. In the past,
applications for changes to approved
new animal drugs may have been
handled inconsistently by sponsors and
the agency. Inconsistency in handling
such applications has been confusing
for sponsors and for CVM, particularly
when reviewing and referencing the
history of specific new animal drug
applications (NADAs). This guidance is
intended to improve consistency in the
way applications for changes are
handled. We believe that consistent
handling of these types of applications
also will help maintain clarity in the
administrative record, which is an
important part of protecting the public
health.
When proposing a change to an
approved new animal drug that may
affect the safety and/or effectiveness of
the drug, such changes generally must
be submitted to FDA either as a new
NADA or a supplemental application to
the original NADA. Category II
supplemental NADAs are the type of
supplement that is used to propose
changes that may require a reevaluation
of certain safety or effectiveness data in
the parent application. Specific changes
meeting the requirements for a Category
II supplemental NADA are described in
21 CFR 514.106(b)(2). This guidance
provides examples and makes specific
recommendations about when a change
to an approved NADA that requires FDA
to review safety and/or effectiveness
data should be submitted as a new
NADA and when such a change should
be submitted as a Category II
supplemental NADA. In addition, the
guidance addresses how to handle
submissions relating to certain types of
proposed changes at the investigational
stage.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information have been approved
under OMB Control No. 0910–0032.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES
) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
http://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
http://www.fda.gov/cvm or http://
www.regulations.gov.
Dated: Decmeber 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29691 Filed 12–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0610]
Draft Guidance for Industry on
Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Postmarketing
Adverse Event Reporting for Medical
Products and Dietary Supplements
During an Influenza Pandemic.’’ The
draft guidance discusses FDA’s
intended approach to enforcement of
adverse event reporting requirements for
drugs, biologics, medical devices, and
dietary supplements during the Federal
Government Response Stages of an
influenza pandemic. The agency makes
recommendations to industry for
focusing limited resources on reports
related to influenza-related products
and other specific types of reports
indicated in the draft guidance.
DATES:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 17, 2009.
ADDRESSES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
E:\FR\FM\16DEN1.SGM
16DEN1

76365
Federal Register/Vol. 73, No. 242 /Tuesday, December 16, 2008 /Notices
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002; or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. The draft
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send one self-addressed
adhesive label to assist that office in
processing your requests. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION
section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding pandemic influenza:
Carmen Maher, Office of
Counterterrorism and Emerging
Threats (HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4067.
Regarding human drug products:
Solomon Iyasu, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4447,
Silver Spring, MD 20993–0002,
301–796–2370.
Regarding human biological products:
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448, 301–827–6210.
Regarding medical device products:
Deborah Moore, Center for Devices
and Radiological Health (HFZ–533),
Food and Drug Administration,
1350 Piccard Dr., Rockville, MD
20850, 240–276–3442.
Regarding dietary supplements: John
Sheehan, Center for Food Safety
and Applied Nutrition (HFS–315),
Food and Drug Administration,
5100 Paint Branch Pkwy., College
Park, MD 20740, 301–436–1488.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic.’’ FDA anticipates
that during an influenza pandemic,
industry and FDA workforces may be
reduced while reporting of adverse
events related to widespread use of
influenza-related products may
increase, although the extent of these
possible changes is unknown. This draft
guidance discusses FDA’s intended
approach to enforcement of adverse
event reporting requirements for drugs,
biologics, medical devices, and dietary
supplements in the event of an
influenza pandemic. The draft guidance
provides recommendations to permit
industry to focus their limited resources
on reports related to influenza-related
products and other specific types of
reports. The draft guidance indicates
FDA’s intention not to object if, during
Federal Government Response Stage 5,
certain required adverse event reports
are not provided within the timeframes
required by statute and regulation, as
long as any delayed reports are then
provided during Federal Government
Response Stage 6.
This draft guidance does not address
monitoring and reporting of adverse
events that might be imposed as a
condition of authorization for products
authorized for emergency use under
section 564 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360bbb-3). This draft guidance also does
not address monitoring and reporting of
adverse events as required by
regulations establishing the conditions
for investigational use of drugs,
biologics, and devices. (See 21 CFR
parts 312 and 812.)
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on postmarketing adverse event
reporting for medical products and
dietary supplements during pandemic
influenza. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES
) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
http://www.regulations.gov.
III. Paperwork Reduction Act of 1995
The draft guidance explains FDA’s
approach to enforcement of adverse
event reporting requirements for drugs,
biologics, medical devices, and dietary
supplements during the Federal
Government Response Stages of an
influenza pandemic, including an intent
not to object to changes in the timing of
submission of certain reports during
some stages of the pandemic response.
The draft guidance refers to reporting
requirements found in 21 CFR 310.305,
314.80, 314.98, 600.80, 606.170, 640.73,
1271.350, and part 803. These
regulations contain collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520) and
are approved under OMB control
numbers 0910–0116, 0910–0291, 0910–
0230, 0910–0308, and 0910–0543.
The draft guidance also refers to
adverse event reports required under
sections 760 and 761 of the act (21
U.S.C. 379aa and 379aa-1), which are
addressed in two draft guidances for
industry. FDA’s October 15, 2007,
notices of availability for those draft
guidances, entitled ‘‘Postmarketing
Adverse Event Reporting for
Nonprescription Human Drug Products
Marketed Without an Approved
Application’’ (72 FR 58316) and
‘‘Questions and Answers Regarding
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act’’ (72 FR 58313), describe
related proposed collections of
information. As required by the PRA,
FDA published analyses of the
information collection provisions of the
October 2007 draft guidances and will
submit the collection of information
analyses to OMB for approval prior to
issuing final guidances.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/cder/guidance/
index.htm or http://www.fda.gov/cber/
guidelines.htm or http://www.fda.gov/
cdrh/guidance.html or http://
www.cfsan.fda.gov/
~
dms/
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\16DEN1.SGM
16DEN1

76366
Federal Register/Vol. 73, No. 242 /Tuesday, December 16, 2008 /Notices
guidance.html or http://
www.regulations.gov.
Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29742 Filed 12–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0365] (formerly
Docket No. 2007D–0117)
Guidance for Industry on Orally
Disintegrating Tablets; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Orally Disintegrating Tablets.’’
The guidance provides pharmaceutical
manufacturers of new and generic
products with an agency perspective on
the definition of an orally disintegrating
tablet (ODT) and also provides
recommendations to applicants who
would like to designate proposed
products as ODTs.
DATES:
Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES:
Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION
section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Frank O. Holcombe, Jr., Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7500


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11775-11776]
[FR Doc No: 2011-4789]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-UST-2010-0625, FRL-9275-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Underground Storage Tanks:
Technical and Financial Requirements and State Program Approval
Procedures (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before April 4, 2011.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-UST-
2010-0625, to (1) EPA online using http://www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Underground Storage
Tank (UST) Docket, Mail Code 28221T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Hal White, Office of Underground
Storage Tanks, Mail Code 5403P, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703)
603-7177; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On August 10, 2010 (75 FR 48325), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-UST-2010-0625, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the UST Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the UST Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, CBI, or other information whose public disclosure
is restricted by statute. For further

information about the electronic docket, go to http://www.regulations.gov.
    Title: Underground Storage Tanks: Technical and Financial
Requirements and State Program Approval Procedures (Renewal).
    ICR numbers: EPA ICR No. 1360.12, OMB Control No. 2050-0068.
    ICR Status: This ICR is scheduled to expire on March 31, 2011.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: Subtitle I of the Resource Conservation and Recovery Act
(RCRA), as amended, requires that EPA develop standards for UST
systems, as may be necessary, to protect human health and the
environment, and procedures for approving state programs in lieu of the
federal program. EPA promulgated technical and financial requirements
for owners and operators of USTs at 40 CFR part 280, and state program
approval procedures at 40 CFR part 281. This ICR is a comprehensive
presentation of all information collection requirements contained at 40
CFR parts 280 and 281.
    The data collected for new and existing UST system operations and
financial requirements are used by owners and operators and/or EPA or
the implementing agency to monitor results of testing, inspections, and
operation of UST systems, as well as to demonstrate compliance with
regulations. EPA believes strongly that if the minimum requirements
specified under the regulations are not met, neither the facilities nor
EPA can ensure that UST systems are being managed in a manner
protective of human health and the environment.
    EPA uses state program applications to determine whether to approve
a state program. Before granting approval, EPA must determine that
programs will be no less stringent than the federal program and contain
adequate enforcement mechanisms.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 14
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: UST facilities and states.
    Estimated Number of Respondents: 211,040.
    Frequency of Response: Once, on occasion, monthly, and annually.
    Estimated Total Annual Hour Burden: 6,751,058.
    Estimated Total Annual Cost: $479,490,266 ($199,841,753 in labor
costs; $60,337,980 in annualized capital/startup costs; and
$219,310,531 in operation and maintenance costs).
    Changes in the Estimates: There is an increase of 781,841 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This is due to updated respondent universe and
burden estimates.

    Dated: February 25, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-4789 Filed 3-2-11; 8:45 am]
BILLING CODE 6560-50-P