[Federal Register Volume 77, Number 157 (Tuesday, August 14, 2012)]
[Notices]
[Pages 48519-48520]
[FR Doc No: 2012-19989]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0390; FRL-9357-7]

Registration Applications for Pesticide Products Containing New
Active Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register
pesticide products containing new active ingredients not included in
any currently registered products pursuant to the provisions of section
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.

DATES: Comments must be received on or before September 13, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0390 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for
hand delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone, email, or mail. Mail correspondence to the Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. As part of the mailing address, include the
contact person's name, division, and mail code.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
If you are commenting in a docket that addresses multiple products,
please indicate to which file symbols your comment applies.
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing active ingredients not included in any previously registered
products pursuant to the provision of section 3(c)(4) of FIFRA. Notice
of receipt of these applications does not imply a decision by the
Agency on the applications.
    1. File Symbol: 6218-IG. Docket Number: EPA-HQ-OPP-2012-0485.
Applicant: Summit Chemical Company, 235 South Kresson Street,
Baltimore, MD 21224-2616. Active Ingredient: Bacillus thuringiensis
subsp. israelensis, Strain SUM-6218 at 100.0%. Product Type: microbial
insecticide. Proposed Use: Manufacturing use. Contact: Denise Greenway,
(703) 308-8263, email address<EMAIL_ADDRESS>    2. File Symbol: 88847-R. Docket Number: EPA-HQ-OPP-2012-0391.
Applicant: Vestaron Corporation, 4717 Campus Drive, Suite 1200,
Kalamazoo, MI 49008. Active Ingredient: GS-U-ACTX-Hv1a-SEQ2 at 30.00%.
Product Type: Insecticide. Proposed Use: Manufacturing use. Contact:
Susanne Cerrelli,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    3. File Symbol: 88847-E. Docket Number: EPA-HQ-OPP-2012-0391.
Applicant: Vestaron Corporation, 4717 Campus Drive, Suite 1200,
Kalamazoo, MI 49008. Active Ingredient: GS-U-ACTX-Hv1a-SEQ2 at 20.00%.
Product Type: Insecticide. Proposed Uses: For use on ornamental plants,
turf, vegetables, fruits, and field crops against a variety of insect
pests. Contact: Susanne Cerrelli,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    4. File Symbol: 89046-E. Docket Number: EPA-HQ-OPP-2012-0507.
Applicant: W.F. Stoneman Company LLC, PO Box 465, McFarlane, WI 53558
(on behalf of AEF Global, 201, Mgr-Bourget, L[eacute]vis Qu[eacute]bec,
G6V 6Z3 Canada). Active Ingredient: Gliocladium roseum strain 321U at
100%. Product Type: Fungicide. Proposed Use: Manufacturing use.
Contact: Kathleen Martin,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    5. File Symbol: 89046-R. Docket Number: EPA-HQ-OPP-2012-0507.
Applicant: W.F. Stoneman Company LLC, PO Box 465, McFarlane, WI 53558
(on behalf of AEF Global, 201, Mgr-Bourget, L[eacute]vis Qu[eacute]bec,
G6V 6Z3 Canada). Active Ingredient: Gliocladium roseum strain 321U at
20%. Product Type: Fungicide. Proposes Uses: As a treatment for green
lumber, to prevent sap staining of sawn wood products and logs.
Contact: Kathleen Martin,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: August 3, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-19989 Filed 8-13-12; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on March 6, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-14336

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  DELTA AIR TRANSPORT N.V. d/b/a SN BRUSSELS AIRLINES

Date Filed:  March 28, 2005, as supplemented February 28, 2006

Relief requested:  Renewal of exemption from 49 USC § 41301 to permit
the applicant to conduct scheduled foreign air transportation of
persons, property, and mail between a point or points behind Belgium,
via Belgium and intermediate points, to a point or point in the United
States, and beyond.  The applicant requests that the authority be
granted for a two-year term.

If renewal, date and citation of last action:  April 11, 2003, in this
Docket.

Applicant representative:  Evelyn D. Sahr,<PHONE_NUMBER>      DOT
analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			       			                        Action date:
March 6, 2006

Effective dates of authority granted:  March 6, 2006, through March 6,
2008.

Basis for approval (bilateral agreement/reciprocity):  United
States-Belgium Air Transport Agreement.

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004

 The applicant states that it currently exercises this authority by
codeshare operations with American Airlines, Inc. (American), whereby SN
Brussels operates to points beyond Brussels in Europe and Africa
carrying the American designator code (AA), and American operates
transatlantic and beyond-gateway intra-U.S. flights carrying the SN
Brussels designator code (SN).  SN Brussels does not currently operate
directly to the U.S. using its own aircraft.


[Federal Register: July 27, 2006 (Volume 71, Number 144)]
[Proposed Rules]
[Page 42622-42623]
[DOCID:fr27jy06-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60, 63, 85, 90, 1048, 1065 and 1068

[EPA-HQ-OAR-2005-0030, FRL-8203-9]
RIN 2060-AM81 and 2060-AN62

Standards of Performance for Stationary Spark Ignition Internal
Combustion Engines and National Emission Standards for Hazardous Air
Pollutants for Reciprocating Internal Combustion Engines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of public comment period.

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SUMMARY: On June 12, 2006 (71 FR 33804), EPA proposed new source
standards of performance for stationary spark ignition internal
combustion engines. EPA also proposed national emission standards for
hazardous air pollutants for stationary reciprocating internal
combustion engines that either are located at area sources of hazardous
air pollutant emissions or that have a site rating of less than or
equal to 500 brake horsepower, and are located at major sources of
hazardous air pollutant emissions. In this notice, we are announcing a
30-day extension of the public comment period.

DATES: Submit comments on or before October 11, 2006.

ADDRESSES: Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2005-0030, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>
     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket and Information Center,
U.S. EPA, Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC
20460. Please include a total of 2 copies. EPA requests a separate copy
also be sent to the contact person identified below (see FOR FURTHER
INFORMATION CONTACT). In addition, please mail a copy of your comments
on the information collection provisions to the Office of Information
and Regulatory Affairs, Office of Management and Budget, Attn: Desk
Officer for EPA, 735 17th St., NW., Washington, DC 20503.
     Hand Delivery: Air and Radiation Docket and Information
Center, U.S. EPA, Room B102, 1301 Constitution Avenue, NW., Washington,
DC. Such deliveries are only accepted during the Docket's normal hours
of operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2005-0030. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. The 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 Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the Air and Radiation Docket is<PHONE_NUMBER>.
    At this time, the EPA/DC's Public Reading Room is closed until
further notice due to flooding. Fax numbers for Docket offices in the
EPA/DC are temporarily unavailable. If you wish to hand deliver
comments during this closure, you may drop them off between the hours
of 8:30 a.m. and 4:30 p.m. eastern standard time (e.s.t.), Monday
through Friday, excluding Federal holidays at the EPA Headquarters
Library, Infoterra Room (room number 3334C) in the EPA West Building
located at 1301 Constitution Ave., NW., Washington, DC. EPA visitors
are required to show photographic identification and sign the EPA
visitor log. After processing through the X-ray and magnetometer
machines, visitors will be given an EPA/DC badge that must be visible
at all times.
    Informational updates will be provided via the EPA Web site at
http://www.epa.gov/epahome/dockets.htm as they are available.

FOR FURTHER INFORMATION CONTACT: Mr. Jaime Pag[aacute]n, Energy
Strategies Group, Sector Policies and Programs Division (D243-01),
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number<PHONE_NUMBER>; facsimile number (919) 541-
5450; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register issued on June 12, 2006 (71
FR 33804), when EPA proposed new source standards of performance for
stationary spark ignition internal combustion engines. EPA also
proposed national emission standards for hazardous air pollutants for
stationary reciprocating internal combustion engines that either are
located at area sources of hazardous air pollutant emissions or that
have a site rating of less than or equal to 500 brake horsepower and
are located at major sources of hazardous air pollutant emissions. On
June 21, 2006, the American Petroleum Institute (API) requested in a
formal letter that EPA extend the comment period of the proposed rule.
The API indicated that an extended comment period was necessary due to
the complexities of the proposed regulation and to be able to develop a
complete set of comments that consider all the support information that
EPA used to develop the proposal. EPA is hereby extending the comment
period, which was set to end on September 11, 2006, to October 11,
2006.

List of Subjects

40 CFR Part 60

    Administrative practice and procedure, Air pollution control,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

40 CFR Part 63

    Administrative practice and procedure, Air pollution control,
Hazardous substances, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

40 CFR Part 85

    Imports, Labeling, Motor vehicle pollution, Reporting and
recordkeeping requirements, Research, Warranties.

40 CFR Part 90

    Administrative practice and procedure, Air pollution control.

40 CFR Part 1048

    Administrative practice and procedure, Air pollution control.

40 CFR Part 1065

    Administrative practice and procedure, Air pollution control,
Reporting and recordkeeping requirements, Research.

    Dated: July 20, 2006.
William L. Wehrum,
Acting Assistant Administrator, Office of Air and Radiation.
 [FR Doc. E6-12053 Filed 7-26-06; 8:45 am]

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302
Federal Register/Vol. 74, No. 2 /Monday, January 5, 2009 /Notices
must contain the name, address,
telephone number, and organizational
affiliation of the presenter.
Written comments should not exceed
five single-spaced typed pages in length
and must be received by January 8,
2009.
The agenda items are subject to
change as priorities dictate.
Contact Person for More Information:
Virginia S. Cain, PhD, Director of
Extramural Research, NCHS/CDC, 3311
Toledo Road, Room 7211, Hyattsville,
Maryland 20782, telephone (301) 458–
4500, fax (301) 458–4020.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: December 24, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–31340 Filed 1–2–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0642]
Draft Guidance for Industry and Food
and Drug Administration Staff; Assay
Migration Studies for In Vitro
Diagnostic Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Assay Migration Studies for In
Vitro Diagnostic Devices.’’ This draft
guidance presents a least burdensome
regulatory approach to gaining FDA
approval of Class III or certain licensed
in vitro diagnostic devices in cases
when a previously approved assay is
migrating (i.e., transitioning) to a New
System for which the assay has not been
previously approved or licensed.
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 April 6, 2009.
ADDRESSES:
Submit written requests for
single copies of the draft guidance
document entitled ‘‘Assay Migration
Studies for In Vitro Diagnostic Devices’’
to the Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850 or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to
CDRH at 240–276–3151. The guidance
may also be obtained by mail by calling
CBER at 1–800–835–4709 or 301–827–
1800. See the
SUPPLEMENTARY
INFORMATION
section for information on
electronic access to the guidance.
Submit written comments concerning
this 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 either
http://www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health (HFZ–440),
Food and Drug Administration,
2098 Gaither Rd., Rockville, MD
20850, 240–276–0711.
For further information concerning
the guidance including statistical
content as it relates to devices
regulated by CBER: Stephen Ripley,
Center for Biologics Evaluation and
Research (HFM–17), Food and Drug
Administration, 1401 Rockville
Pike, suite 200N Rockville, MD
20852, 301–827–6210
For further information concerning
the statistical content in the
guidance: Marina V. Kondratovich,
Center for Devices and Radiological
Health (HFZ–550), Food and Drug
Administration, 1350 Piccard Drive,
Rockville, MD 20850, 240–276–
3126.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance presents a least
burdensome regulatory approach to gain
FDA’s approval of Class III or certain
licensed in vitro diagnostic devices,
when a previously approved assay is
migrating (i.e., transitioning) to a New
System, for which the assay has not
been previously approved or licensed.
The regulatory approach in this
guidance is also applicable to some
510(k) cleared devices, when the device
transitioning to a new system presents
specific concerns, either because of the
nature of the analyte and indications, or
because of the specific technology used
(e.g., nucleic acid amplification tests).
The focus of this guidance is on the
study designs and performance criteria
that should be fulfilled, so that sponsors
can utilize the migration study approach
in support of the change. The FDA
believes that the assay migration study
paradigm proposed in this draft
guidance, provides a least burdensome
scientific and regulatory pathway for
manufacturers to transfer a previously
approved or licensed assay, with full
clinical data from an Old System to a
New System (previously not approved
or licensed). The paradigm is suitable in
cases when sufficient knowledge can be
derived from the documentation of
design controls, risk analyses, and prior
performance studies on an Old System.
II. Significance of Guidance
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 assay migration studies for in vitro
diagnostic devices. 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 statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Assay
Migration Studies for In Vitro
Diagnostic Devices,’’ you may either
send an e-mail request to
<FONT STYLE="font-size<EMAIL_ADDRESS>to receive an
electronic copy of the document or send
a fax request to 240–276–3151 to receive
a hard copy. Please use the document
number 1660 to identify the guidance
you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
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submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
http://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at http://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the CBER Internet site at http://
www.fda.gov/cber/guidelines.htm or on
the Division of Dockets Management
Internet site at http://
www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance documents. 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 in
21 CFR part 807 subpart E have been
approved under OMB Control Number
0910–0120; the collections of
information in 21 CFR part 814 have
been approved under OMB Control
Number 0910–0231; the collections of
information in 21 CFR part 801 and 809
have been approved under OMB Control
Number 0910–0485; the collections of
information in 21 CFR 820 have been
approved under OMB Control Number
0910–0073; and the collections of
information in 21 CFR part 601 have
been approved under OMB Control
Number 0910–0338.
V. 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.
Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–31319 Filed 1–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–D–0437] (formerly
Docket No. 2004D–0549)
Guidance for Industry on Labeling
Over-the-Counter Human Drug
Products—Questions and Answers;
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 ‘‘Labeling OTC Human Drug
Products—Questions and Answers.’’
This guidance is intended to assist
manufacturers, packers, and distributors
of over-the-counter (OTC) drug products
in complying with the agency’s
regulation on standardized content and
format requirements for the labeling of
OTC drug products. This guidance
primarily discusses labeling questions
that have been frequently asked by
manufacturers, packers, and distributors
relating to these requirements. The
labeling examples in this guidance show
various format and content features and
suggest how OTC drug monograph
labeling information finalized before the
new requirements can be converted to
the new format. This guidance finalizes
the draft guidance of the same name
published January 13, 2005 (70 FR
2415).
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:
Gerald M. Rachanow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5496,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Labeling OTC Human Drug Products—
Questions and Answers.’’ This is one of
several guidances the agency has
developed to help manufacturers,
packers, and distributors implement the
final rule establishing standardized
content and format requirements for the
labeling of all OTC drug products. Once
finalized, these guidances supersede all
other statements, feedback, and
correspondence provided by the agency
on these matters since the issuance of
the final rule.
In the Federal Register of March 17,
1999 (64 FR 13254), FDA published a
final rule establishing standardized
content and format requirements for the
labeling of OTC drug products (§201.66
(21 CFR 201.66)). This regulation is
intended to standardize labeling for all
OTC drug products so consumers can
easily read and understand OTC drug
product labeling and use these products
safely and effectively.
The regulation requires manufacturers
to present OTC drug labeling
information in a prescribed order and
format. The standardized format
requires revision of all prior labeling
and covers all OTC drug and drug-
cosmetic products, whether marketed
under a new drug application,
abbreviated new drug application, or
OTC drug monograph (or drug product
not yet the subject of a final OTC drug
monograph).
Following issuance of the final rule,
the agency received a number of
inquiries from manufacturers seeking
guidance on how to present the labeling
information for their OTC drug products
using the standardized content and
format requirements. To address these
inquiries, FDA published a notice in the
Federal Register of January 13, 2005 (70
FR 2415), announcing the availability of
a draft guidance for industry entitled
‘‘Labeling OTC Human Drug Products—
Questions and Answers.’’ That draft
guidance summarized the new Drug
Facts labeling requirements as set forth
in §201.66. The draft guidance
discussed those industry inquiries and
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