[Federal Register Volume 78, Number 8 (Friday, January 11, 2013)]
[Notices]
[Page 2380]
[FR Doc No: 2013-00367]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-30-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Application

    Take notice that on December 19, 2012, Transcontinental Gas Pipe
Line Company, LLC (Transco), Post Office Box 1396, Houston, Texas
77251, filed in the above referenced docket an application pursuant to
section 7(c) of the Natural Gas Act (NGA) for authorization to
construct, install, own, operate and maintain its Virginia Southside
Expansion Project (Project), an incremental expansion of Transco's
existing pipeline system in its southern market area. Specifically, the
Project involves the construction and operation of 91 miles of new
pipeline facilities along Transco's existing South Virginia Lateral A
and approximately 7 miles of Greenfield pipeline facilities; a new
compressor station with two 10,915 horsepower (ISO) gas turbine-driven
compressor; and the construction or modification of associated above
ground and underground facilities. Further, the Project will provide
270,000 dekatherms per day (Dth/d) of incremental firm transportation
service to Virginia Power Services Energy Corp., Inc. and Piedmont
Natural Gas Company, Inc. Transco estimates that the proposed project
will cost approximately $275 million, net of the Grant Transco expects
to receive from the Virginia Tobacco Indemnification and Community
Revitalization Commission. Finally, Transco proposes to place the
Project facilities into service on September 1, 2015, all as more fully
set forth in the application which is on file with the Commission and
open to public inspection. The filing is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Bela
Patel, Regulatory Analyst, Transcontinental Gas Pipe Line Company, LLC,
P.O. Box 1396, Houston, Texas 77251, telephone no.<PHONE_NUMBER>, and
email<EMAIL_ADDRESS>    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: January 25, 2013.

    Dated: January 4, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-00367 Filed 1-10-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Proposed Rules]
[Page 9965-9967]
[DOCID:fr25fe08-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0197; Directorate Identifier 2008-CE-005-AD]
RIN 2120-AA64

Airworthiness Directives; Dornier Luftfahrt GmbH Models 228-100,
228-101, 228-200, 228-201, 228-202, and 228-212 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the

products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    The manufacturer reported findings of missing primer on the
internal of the elevator and rudder of aircraft S/N 8200. The
aircraft S/N 8200 was with RUAG for maintenance purposes.
Investigation performed by RUAG showed that the paint removal
procedure for the rudder and elevator was changed from a paint
stripping with brush and scraper to a procedure where the parts were
submerged in a tank filled with hot liquid stripper. The stripper is
called TURCO 5669 from Henkel Surface Technologies. The stripping
process is described in the Technical Process Bulletin No. 238799
dated 09/01/1999. This paint stripping process change was not
communicated to and not approved by the TC-Holder.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by March 26, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0197;
Directorate Identifier 2008-CE-005-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Luftfahrt-Bundesamt (LBA), which is the airworthiness authority
for Germany, has issued German AD D-2007-350, dated December 19, 2007
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    The manufacturer reported findings of missing primer on the
internal of the elevator and rudder of aircraft S/N 8200. The
aircraft S/N 8200 was with RUAG for maintenance purposes.
Investigation performed by RUAG showed that the paint removal
procedure for the rudder and elevator was changed from a paint
stripping with brush and scraper to a procedure where the parts were
submerged in a tank filled with hot liquid stripper. The stripper is
called TURCO 5669 from Henkel Surface Technologies. The stripping
process is described in the Technical Process Bulletin No. 238799
dated 09/01/1999. This paint stripping process change was not
communicated to and not approved by the TC-Holder.

    The MCAI requires you to do a visual inspection of the inner
structure of the rudder and elevator for signs of corrosion, debonded
primer (yellow-green), and any other deviation of surface protection;
report corrosion beyond the acceptable level or areas with debonded
primer to the manufacturer; and, if necessary, repair the affected
parts following the applicable FAA-approved manufacturer repair
instruction. You may obtain further information by examining the MCAI
in the AD docket.

Relevant Service Information

    RUAG Aerospace Defence Technology has issued Dornier 228 Service
Bulletin No. SB-228-270, dated October 30, 2007. The actions described
in this service information are intended to correct the unsafe
condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 8 products of U.S. registry. We also estimate that
it would take about 3 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $1,920, or $240 per product.
    We have no way of determining the number of products that may need
any necessary follow-on actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.

    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Dornier Luftfahrt GmbH: Docket No. FAA-2008-0197; Directorate
Identifier 2008-CE-005-AD.

Comments Due Date

    (a) We must receive comments by March 26, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Models 228-100, 228-101, 228-200, 228-
201, 228-202, and 228-212 airplanes, serial numbers 8009, 8065,
8112, 8179, 8185, 8191, 8241, and 8244, certificated in any
category.

Subject

    (d) Air Transport Association of America (ATA) Code 51:
Structures.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

``The manufacturer reported findings of missing primer on the
internal of the elevator and rudder of aircraft S/N 8200. The
aircraft S/N 8200 was with RUAG for maintenance purposes.
Investigation performed by RUAG showed that the paint removal
procedure for the rudder and elevator was changed from a paint
stripping with brush and scraper to a procedure where the parts were
submerged in a tank filled with hot liquid stripper. The stripper is
called TURCO 5669 from Henkel Surface Technologies. The stripping
process is described in the Technical Process Bulletin No. 238799
dated 09/01/1999. This paint stripping process change was not
communicated to and not approved by the TC-Holder.''

    The MCAI requires you to do a visual inspection of the inner
structure on rudder and elevator for signs of corrosion, de-bonded
primer (yellow-green), and any other deviation of surface
protection; report corrosion beyond the acceptable level or areas
with de-bonded primer to the manufacturer; and, if necessary, repair
the affected parts following the applicable FAA-approved
manufacturer repair instruction.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within 2 months after the effective date of this AD, do a
detailed visual inspection on the inner structure of the rudder and
elevator for signs of corrosion, de-bonded primer (yellow-green),
and any other deviation of surface protection following RUAG
Aerospace Defence Technology Dornier 228 Service Bulletin No. SB-
228-270, dated October 30, 2007.
    (2) If you find corrosion or areas with debonded primer as a
result of the inspection required by paragraph (f)(1) of this AD,
before further flight, do the following:
    (i) Report the inspection results to RUAG Aerospace Services
GmbH, Dornier 228 Customer Support, P.O. Box 1253, 82231 Wessling,
Federal Republic of Germany, telephone: +49 (0)8153-30-2280; fax:
+49 (0) 8153-30-3030 and request FAA-approved repair instructions
following RUAG Aerospace Defence Technology Dornier 228 Service
Bulletin No. SB-228-270, dated October 30, 2007.
    (ii) Repair corrosion following FAA-approved repair instructions
obtained from RUAG Aerospace Services GmbH.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: The MCAI includes provisions for reporting corrosion
``beyond the acceptable level.'' However, the service information
does not include a definition of ``acceptable level.'' Therefore, to
ensure the AD is clear for U.S. operators and is enforceable, this
AD does not include the qualifier ``beyond the acceptable level.''

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI German AD D-2007-350, dated December 19, 2007;
and RUAG Aerospace Defence Technology Dornier 228 Service Bulletin
No. SB-228-270, dated October 30, 2007, for related information.

    Issued in Kansas City, Missouri, on February 13, 2008.
David R. Showers,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-3407 Filed 2-22-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12310-12311]
[FR Doc No: 2012-4781]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1978-N-0441] (formerly 78N-0324); DESI 10392]

Drugs for Human Use; Drug Efficacy Study Implementation;
Prescription Drugs That Contained Hydroxyzine Hydrochloride or
Hydroxyzine Pamoate; Final Resolution of Docket

ACTION: Notice; withdrawal of a hearing request.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that all
outstanding hearing requests pertaining to Docket FDA-1978-N-0441
(formerly 78N-0324) have been withdrawn. Therefore, shipment in
interstate commerce of any of the products identified in that docket,
or any identical, related, or similar (IRS) product that is not the
subject of an approved new drug application (NDA) or abbreviated new
drug application (ANDA) (other than an over-the-counter (OTC) product
that complies with an applicable OTC monograph), is unlawful as of the
effective date of this notice.

DATES: Effective Date: This notice is effective February 29, 2012.

ADDRESSES: All communications in response to this notice should be
identified with the docket number found in brackets in the heading of
this document, and directed to Pamela Lee, Office of Unapproved Drugs
and Labeling Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5173,
Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Pamela Lee, Office of Unapproved Drugs
and Labeling Compliance, Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5173, Silver Spring, MD 20993-0002, 301-
796-3297, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    When initially enacted in 1938, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) required that ``new drugs'' be approved for
safety by FDA before they could legally be sold in interstate
commerce.\1\ To this end, the FD&C Act made it the sponsor's
responsibility, before marketing a new drug, to submit an NDA to FDA to
prove that its drug was safe. Between 1938 and 1962, if a drug obtained
approval, FDA considered drugs that were IRS \2\ to the approved drug
to be ``covered'' by that approval, and allowed those IRS drugs to be
marketed without independent approval.
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    \1\ A ``new drug'' is defined by the FD&C Act as a drug that
``is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in the labeling thereof,
except that such a drug not so recognized shall not be deemed to be
a `new drug' if at any time prior to the enactment of this Act it
was subject to the Food and Drugs Act of June 30, 1906, as amended,
and if at such time its labeling contained the same representations
concerning the conditions of its use * * *.'' (21 U.S.C. 321(p)).
    \2\ Section 310.6(b)(1) ((21 CFR 310.6(b)(1)) provides: ``An
identical, related, or similar drug includes other brands,
potencies, dosage forms, salts, and esters of the same drug moiety
as well as of any drug moiety related in chemical structure or known
pharmacological properties.''
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    In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe, to
obtain FDA approval. This amendment also caused FDA to conduct a
retrospective evaluation of the effectiveness of the drug products that
FDA had approved as safe between 1938 and 1962. FDA contracted with the
National Academy of Sciences/National Research Council (NAS/NRC) to
make an initial evaluation of the effectiveness of over 3,400 products
that had been approved only for safety between 1938 and 1962. The NAS/
NRC reports for these drug products were submitted to FDA in the late
1960s and early 1970s. The Agency reviewed and re-evaluated the reports
and published its findings in Federal Register notices. FDA's
administrative implementation of the NAS/NRC reports was called the
Drug Efficacy Study Implementation (DESI). DESI covered the
approximately 3,400 products specifically reviewed by the NAS/NRC, as
well as the even larger number of IRS products that entered the market
without FDA approval.
    All drugs covered by the DESI review are ``new drugs'' under the
FD&C Act. If FDA's final DESI determination classifies a drug product
as lacking substantial evidence of effectiveness for one or more
indications, that drug product and those IRS to it may no longer be
marketed for the indications and are subject to enforcement action as
unapproved new drugs. If FDA's final DESI determination classifies the
drug product as effective for one or more of its labeled indications,
the drug can be marketed for those indications, provided it is the
subject of an application approved for safety and effectiveness.
Sponsors of drug products that have been found to be effective for one
or more indications through the DESI process may rely on FDA's
effectiveness determinations, but typically must update their labeling
to conform to the indication(s) found to be effective by FDA and
include any additional safety information required by FDA. Those drug
products with NDAs approved before 1962 for safety therefore require
approved supplements to their original applications if one or more
indications are found to be effective under DESI; IRS drug products
require an approved NDA or ANDA, as appropriate. Furthermore, labeling
for drug products classified as effective may contain only those
indications for which the review found the product effective, unless
the firm marketing the product has received an approval for the
additional indication(s).

II. Docket No. FDA-1978-N-0441 (formerly 78N-0324); DESI 10392

    Under Docket No. FDA-1978-N-0441 (formerly 78N-0324), FDA evaluated
the evidence of effectiveness for various indications for Atarax
Tablets (NDA 10-392), Atarax Syrup (NDA 10-485), Vistaril Injection
(NDA 11-111), Vistaril Capsules (NDA 11-459), and Vistaril Oral
Suspension (NDA 11-795), products owned by Pfizer, Inc. (Pfizer),

and B. Roerig & Co., then a division of Pfizer, that contained
hydroxyzine hydrochloride and hydroxyzine pamoate (44 FR 6780, February
2, 1979) (the February 1979 Federal Register notice). Although some
indications for these products were found to be supported by adequate
and well-controlled clinical studies, other indications were determined
to be lacking substantial evidence of effectiveness (Id.). The February
1979 Federal Register notice offered an opportunity for hearing with
respect to the indications found to be lacking substantial evidence of
effectiveness, as well as with respect to any issues relating to the
legal status of the drug products subject to it.
    In response to the February 1979 Federal Register notice, Pfizer
requested a hearing. No other companies requested a hearing. On
November 22, 2010, FDA sent a letter to Pfizer to determine whether
Pfizer remained interested in pursuing its hearing request. On December
22, 2010, Pfizer responded by withdrawing its hearing request. There
are no longer outstanding hearing requests pertaining to Docket No.
FDA-1978-N-0441 (formerly 78N-0324). Therefore, shipment in interstate
commerce of any product identified in this docket, or any IRS product,
that is not the subject of an approved NDA or ANDA is unlawful as of
the effective date of this notice. This notice is not applicable to OTC
products that comply with an OTC monograph (21 CFR 310.6(f)). Any
person who wishes to determine whether a specific product is covered by
this notice should write to the Center for Drug Evaluation and Research
(see ADDRESSES).

III. Discontinued Products

    Some firms may have previously discontinued the manufacturing or
distribution of products covered by this notice without removing them
from the listing of their products under section 510(j) of the FD&C Act
(21 U.S.C. 360(j)). Other firms may discontinue manufacturing or
marketing listed products in response to this notice. Firms that wish
to notify the Agency of product discontinuation should send a letter,
signed by the firm's chief executive officer, fully identifying the
discontinued product(s), including National Drug Code (NDC) number(s),
and stating that the product(s) have been discontinued. The letter
should be sent to Pamela Lee (see ADDRESSES).
    Firms should also update the listing of their products under
section 510(j) of the FD&C Act to reflect discontinuation of unapproved
products. FDA plans to rely on its existing records, including drug
listing records or other available information, when it targets
violations for enforcement action. Firms should be aware that after the
effective date of this notice, FDA intends to take enforcement action
without further notice against any firm that manufactures or ships in
interstate commerce any unapproved product covered by this notice.

IV. Reformulated Products

    FDA cautions firms against reformulating products into OTC products
or different unapproved new drugs that are marketed under the same name
or substantially the same name (including a new name that contains the
old name). Reformulated products marketed under a name previously
identified with a different active ingredient or combination of active
ingredients have the potential to confuse health care practitioners and
harm patients.
    This notice is issued under the FD&C Act (sections 502 and 505 (21
U.S.C. 352 and 355)), and under authority delegated to the Deputy
Commissioner for Policy under section 1410.10 of the FDA Staff Manual
Guide.

    Dated: February 17, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-4781 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P