Document ID: FDA-2008-N-0341-0006
Agency: fda
Document Type: Rule
Title: Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
Posted Date: 2009-07-28T04:00Z

[Federal Register: July 28, 2009 (Volume 74, Number 143)]
[Rules and Regulations]               
[Page 37163-37168]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy09-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. FDA-2008-N-0341]
RIN 0910-AG19

 
Applications for Food and Drug Administration Approval To Market 
a New Drug; Postmarketing Reports; Reporting Information About 
Authorized Generic Drugs

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending its 
regulations to require that the holder of a new drug application (NDA) 
submit certain information regarding authorized generic drugs in an 
annual report. We are taking this action as part of our implementation 
of the Food and Drug Administration Amendments Act of 2007 (FDAAA). 
FDAAA requires that FDA publish a list of all authorized generic drugs 
included in an annual report since 1999, and that the agency update the 
list quarterly.

DATES:  This final rule is effective January 25, 2010.

ADDRESSES:  For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Michelle D.D. Bernstein, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6362, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 29, 2008 (73 FR 56487), FDA 
published a direct final rule to amend Sec.  314.3 (21 CFR 314.3) to 
add a definition of ``authorized generic drug'' and Sec.  314.81 (21 
CFR 314.81) to require that an NDA holder specifically report that it 
has marketed an authorized generic drug during the applicable time 
period. We explained that we issued this rule as a direct final rule 
because we believed it was noncontroversial and that there was little 
likelihood of receiving significant

[[Page 37164]]

adverse comments. We concurrently published in the Federal Register of 
September 29, 2008 (73 FR 56529) a companion proposed rule, identical 
in substance to the direct final rule, that provided a procedural 
framework from which to proceed with standard notice-and-comment 
rulemaking in the event we were required to withdraw the direct final 
rule because of significant adverse comments. A significant adverse 
comment is defined as a comment that explains why the rule would be 
inappropriate, including challenges to the rule's underlying premise or 
approach, or would be ineffective or unacceptable without a change. Any 
comments received under the companion proposed rule were treated as 
comments regarding the direct final rule and vice versa. A full 
description of FDA's policy on direct final rule procedures may be 
found in a guidance document published in the Federal Register of 
November 21, 1997 (62 FR 62466).
    We received four comments on the proposed rule, which included 
several comments that were arguably significant adverse comments. 
Therefore, in the Federal Register of February 10, 2009 (74 FR 6541), 
we withdrew the direct final rule. This final rule summarizes and 
responds to the comments received on the direct final rule and proposed 
rule. See section III of this document for a discussion of the comments 
and FDA's responses.
    On September 27, 2007, the President signed into law FDAAA (Public 
Law 110-85, 121 Stat. 823). Section 920 of FDAAA adds new section 
505(t) to the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
355(t)). Section 505(t) of the act requires that FDA take the following 
actions:
     Publish on its Internet site a complete list of all 
authorized generic drugs included in an annual report submitted to the 
agency after January 1, 1999, consisting of the drug trade name, the 
brand company manufacturer, and the date the authorized generic drug 
entered the market;
     Update the list quarterly; and
     Notify relevant Federal agencies, including the Centers 
for Medicare and Medicaid Services and the Federal Trade Commission, 
that the list has been published and will be updated quarterly.
    For purposes of publishing the list, section 505(t)(3) of the act 
defines the term ``authorized generic drug'' as a ``listed drug (as 
that term is used in [section 505(j) of the act]) that has been 
approved under [section 505(c) of the act] and is marketed, sold, or 
distributed directly or indirectly to retail class of trade under a 
different labeling, packaging (other than repackaging as the listed 
drug in blister packs, unit doses, or similar packaging for use in 
institutions), product code, labeler code, trade name, or trade mark 
than the listed drug.'' On June 27, 2008, based on information 
available to FDA at that time, the agency initially published the list 
of authorized generic drugs on FDA's Web site at http://www.fda.gov/
cder/ogd/AG_Listing.htm.

A. The Proposed Rule

    Currently, there is no requirement that an NDA holder specifically 
report that it is marketing an ``authorized generic drug.'' NDA holders 
are required to include information about distribution or certain 
changes to manufacturing or labeling in annual reports, which may 
indicate that an authorized generic is being marketed. However, annual 
reports may not include all the information necessary for FDA to 
publish the list required by FDAAA. For example, sponsors rarely 
include the date the authorized generic entered the market.
    As stated in the proposed rule, to allow FDA to accurately report a 
complete list of all authorized generic drugs included in annual 
reports and to update the list in a timely fashion, we proposed to add 
a requirement that annual reports specifically and clearly include the 
information we are required to report. In addition, we proposed that 
the NDA holder report the date the authorized generic drug ceased being 
distributed to ensure that the list is as accurate and up-to-date as 
possible. The first annual report submitted after implementation of 
this regulation must provide information regarding any authorized 
generic drug that was marketed during the time period covered by an 
annual report submitted after January 1, 1999.

B. Changes to the Proposed Rule

    We received a number of comments on the proposed rule regarding 
submission of the required information. Some of the comments requested 
clarification about electronic submission of the information and urged 
speedy adoption of an electronic means for submission of the 
information. One comment opposed the provision requiring separate 
submission of the information by mail in either hard copy or electronic 
format in addition to submission as part of the annual report. We 
address all of the comments in section III of this document.
    After considering the comments, we have concluded that it is 
appropriate to make a revision to the proposed rule to permit e-mail 
submission of the required information in addition to regular mail, 
including courier delivery. The final rule revises proposed Sec.  
314.81(b)(2)(ii)(b) to allow NDA holders to send the required 
information to the Authorized Generics electronic mailbox at 
AuthorizedGenerics@fda.hhs.gov with ``Authorized Generic Submission'' 
indicated in the subject line.
    We also revised the last line of that section to clarify when 
separate submission of the authorized generics information is required 
by this rule. When information is included in an annual report about an 
authorized generic drug, the final rule requires that a copy of that 
portion of the annual report be sent to a central office in the agency 
that will compile the list of authorized generic drugs and update it 
quarterly. At such time as FDA requires electronic submission of annual 
reports through a system that allows for the extraction of relevant 
information from annual reports, separate submission of the information 
will no longer be required.
    Finally, on our own initiative, we have also revised Sec.  
314.81(b)(2)(ii)(b) to provide a new mailing address (street address) 
for submissions made by regular mail.

II. Description of the Final Rule

    We are amending our regulations in Sec.  314.3 (21 CFR 314.3) to 
add a definition for the term ``authorized generic drug.'' The 
definition provides that an authorized generic drug is a listed drug 
(as defined in Sec.  314.3 (21 CFR 314.3)) that has been approved under 
section 505(c) of the act and is marketed, sold, or distributed 
directly or indirectly to retail class of trade with either labeling, 
packaging (other than repackaging as the listed drug in blister packs, 
unit doses, or similar packaging for use in institutions), product 
code, labeler code, trade name, or trade mark that differs from that of 
the listed drug.
    We are also amending our regulations in Sec.  314.81 (21 CFR 
314.81) to require that an NDA holder specifically report that it has 
marketed an authorized generic drug during the applicable time period. 
Section 314.81(b)(2) requires that an NDA holder submit an annual 
report within 60 days of the anniversary date of approval of an NDA for 
every NDA it holds. We are amending Sec.  314.81 by redesignating 
paragraph (b)(2)(ii) regarding distribution data as paragraph 
(b)(2)(ii)(a), and adding a new paragraph (b)(2)(ii)(b) regarding 
marketing of authorized generic drugs. Under this new paragraph, if an 
authorized generic drug was marketed under an NDA, or

[[Page 37165]]

ceased to be marketed, during the reporting year, the annual report 
must list the date the authorized generic drug entered the market, or 
the date the authorized generic drug ceased being distributed, and the 
corresponding trade or brand name. Each dosage form and/or strength is 
a different authorized generic drug and should be listed separately. 
The first annual report submitted after implementation of this 
regulation must include the required marketing information for any 
authorized generic drug that was marketed during the time period 
covered by an annual report submitted after January 1, 1999.
    If information is included in the annual report with respect to any 
authorized generic drug, a copy of the portion of the annual report 
with that information must be sent to the Food and Drug Administration, 
Center for Drug Evaluation and Research, Office of New Drug Quality 
Assessment, Bldg. 21, rm. 2562, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, and marked ``Authorized Generic Submission''; or 
to the Authorized Generics electronic mailbox at 
AuthorizedGenerics@fda.hhs.gov with ``Authorized Generic Submission'' 
indicated in the subject line. This final rule assumes that the copy of 
the relevant portion of the annual report may currently be submitted in 
one of several different formats (e.g., a paper copy, a PDF document on 
a computer disc, or an e-mail containing the required information). 
Although annual reports may currently be submitted in electronic format 
to the relevant division responsible for reviewing a particular NDA, 
current capabilities do not permit us to create a centralized 
authorized generics database by extracting information from the 
relevant portion of the annual reports submitted in that format. 
However, FDA is committed to adapting its business practices to 
evolving technology, including using the significant advancements in 
Web-based, electronic systems. In anticipation of the future changes, 
this final rule provides that once an electronic submission format is 
mandated for annual reports and new requirements for electronic 
submission to the agency of annual reporting information are 
established, the authorized generics information will then be required 
to be submitted as part of the annual report submission in accordance 
with the new requirements. Separate submission of the information will 
no longer be required when FDA has a method of extracting the relevant 
information from annual reports.

III. Comments on the Proposed Rule and FDA's Responses

    We received four comments in response to the proposed rule. 
Comments were received from individual consumers and industry 
organizations. A summary of the comments received and our responses 
follow.

A. General Comments

    (Comment 1) Two comments generally supported the proposed rule. One 
of these comments urged FDA to require submission of additional 
information, such as the brand name associated with the authorized 
generic drug and whether a prescription is required, for inclusion on 
the list of authorized generic drugs.
    (Response) FDA appreciates the supportive comments. Regarding the 
submission of additional information suggested by the commenter, note 
that this final rule requires, as we proposed, that annual reports list 
the date each authorized generic drug entered the market, the date each 
authorized generic drug ceased being distributed, and the corresponding 
trade or brand name. We do not believe it is necessary to also require 
prescription status to be reported to FDA and included on the list 
because such information is easily obtained from product labeling or 
other publicly available sources if the trade name is known. The 
information required to be reported under new Sec.  314.81(b)(2)(ii)(b) 
of the regulations tracks the requirements of section 505(t) of the act 
and adequately informs the public of the marketing of an authorized 
generic drug. Thus, we decline to adopt the suggestion to require 
submission of prescription status information.
    (Comment 2) One comment requested that we clarify the contents of 
the required submission, particularly with regard to distribution data 
that is required to be submitted under current Sec.  314.81(b)(2)(ii) 
with the annual report.
    (Response) As stated in section II of this document, the 
information we are requiring be submitted separately for authorized 
generic drugs is the date each authorized generic drug entered the 
market, the date each authorized generic drug ceased being distributed, 
and the corresponding trade or brand name. Current Sec.  
314.81(b)(2)(ii) requires that distribution data about a drug product 
marketed under an approved NDA be submitted with the annual report. In 
the codified of this final rule, Sec.  314.81(b)(2)(ii) is renumbered 
as Sec.  314.81(b)(2)(ii)(a), but otherwise remains unchanged. 
Distribution data is not required to be separately submitted under this 
rule for inclusion on the authorized generic drug list.

B. Comments on Electronic Submission

    (Comment 3) One comment requested clarification about electronic 
submission of the required information. Another comment urged speedy 
adoption of an electronic means for submission of the required 
information.
    (Comment 4) One comment opposed the provision requiring separate 
submission of the required information by mail in either hard copy or 
electronic format. The comment stated that this provision is contrary 
to FDA's long-standing record of encouraging and facilitating 
electronic regulatory submissions and to its goal to use information 
technology to facilitate the application and review processes. The 
commenter believes that for annual reports currently submitted in 
electronic format, FDA should not require separate submission of the 
authorized generic information to the Office of Pharmaceutical Science.
    (Response) The purpose of this rule is to facilitate FDA's 
obligation to accurately report a complete list of all authorized 
generic drugs included in annual reports and to update the list in a 
timely fashion. To fulfill our obligation, we need ready access to the 
required information. Therefore, in this final rule, we are requiring 
that the section 505(t) of the act information be separately sent to 
us, as proposed. However, in response to the comments, we have modified 
the language in Sec.  314.81(b)(2)(ii)(b) to provide that the 
authorized generics information may also be submitted to FDA using e-
mail, in lieu of sending the information by regular mail or courier. 
FDA believes this will provide an alternative method of submission that 
may be more convenient for some sponsors. We encourage sponsors that 
currently elect to submit their annual reports in electronic format to 
continue to do so. At such time that electronic submission of annual 
reports is mandated by FDA and FDA develops the capability to readily 
retrieve information it needs to comply with section 505(t) of the act, 
separate submission of the authorized generic information will no 
longer be necessary, and the language in Sec.  314.81(b)(2)(ii)(b) of 
the codified has been clarified to reflect this. Until electronic 
submission of annual reports is required and FDA can readily retrieve 
the authorized generics information from the annual reports database, 
sponsors must submit the authorized generics information separately by 
regular mail or e-mail (regardless of

[[Page 37166]]

what format the sponsor currently uses to submit its annual report).

C. Comment on Effective Date

    (Comment 5) One comment opposed the proposed rule because it does 
not ``prioritize collection of information on currently distributed 
authorized generic drugs.'' The commenter suggested that FDA first 
require sponsors to report information about currently distributed 
authorized generic drugs and, at a later stage, require reporting of 
information on authorized generic drugs marketed after 1999 but 
subsequently discontinued. The same commenter requested that FDA 
provide for an effective date that would allow sponsors time for 
advance planning, revision of operating procedures governing 
preparation of annual reports, and review of historical records.
    (Response) We have adopted an effective date of 6 months after 
publication of this final rule. We believe that 6 months will allow 
time for advance planning, revision of operating procedures, and any 
review of historical records that would be necessary to collect the 
required information on marketing of authorized generic drugs since 
1999 that must be reported under new Sec.  314.81(b)(ii)(b) of the 
regulations. Because we have adopted an effective date that permits 
adequate time for manufacturers/sponsors to collect and report 
information on both currently marketed authorized generic drugs and 
authorized generic drugs marketed since 1999, it is not necessary to 
adopt the two-stage reporting process recommended by the commenter. 
Accordingly, we decline to revise the final rule to adopt such a 
process.

D. Comment on Definition

    (Comment 6) One comment stated that the definition of authorized 
generic drugs adopted in this rule has the effect of requiring the 
reporting of certain products (and capturing these products on the 
published list) that Congress did not intend to be reported as 
authorized generic drugs or included on a list of authorized generic 
drugs. The comment further stated that capturing and listing products 
that Congress does not consider authorized generic drugs complicates 
and slows the efficient and timely use of the information. The 
commenter urged FDA to exercise its enforcement discretion to collect 
information only for products that Congress considers authorized 
generic drugs.
    (Response) The definition of authorized generic drugs we proposed 
is substantially identical to the definition Congress provided in 
section 505(t) of the act. Absent some clear indication that Congress 
did not intend to include in the scope of section 505(t) certain 
products which clearly fall within the plain language of the 
definition, it would be inappropriate for FDA to narrow or otherwise 
alter the statutory definition of authorized generic drug. FDA's 
mandate is to publish a complete list of authorized generic drugs as 
defined in section 505(t) of the act, and to update the list quarterly. 
Accordingly, we decline to adopt the commenter's suggestion to revise 
the definition of authorized generic drugs to collect information about 
a narrower range of products than Congress specified in the act.

IV. Legal Authority

    The act, as amended by FDAAA, provides authority for FDA to issue 
this final rule. Section 505(t) of the act requires that FDA publish a 
complete list of all authorized generic drugs included in an annual 
report submitted to the agency after January 1, 1999, and to update 
that list quarterly. In addition, section 701(a) of the act (21 U.S.C. 
371(a)) provides general authority for FDA to issue regulations for the 
efficient enforcement of the act. This final rule amends FDA's existing 
regulations regarding annual reports to ensure that the information 
necessary for the agency to fulfill its obligation under section 505(t) 
is clearly reported.

V. Environmental Impact

    The agency has determined under 21 CFR part 25 that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule imposes only minimal 
regulatory obligations, the agency certifies that the final rule will 
not have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $130 million, using the most current (2007) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The only costs of this final rule are associated with the Paperwork 
Reduction Act of 1995 (the PRA) burden, described in section VII of 
this document. If we assume an average hourly wage plus benefits of $56 
for the reporting personnel, the annual cost is about $29,000 ($56 per 
hour x 520 hours).

VII. The Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the PRA (44 U.S.C. 3501-3520). The title, description, and respondent 
description of the information collection provisions are shown with an 
estimate of the annual reporting and recordkeeping burden in table 1 of 
this document. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Applications for FDA Approval to Market a New Drug; 
Postmarketing Reports; Reporting Information About Authorized Generic 
Drugs
    Description: This rulemaking requires the holder of an NDA to 
notify the agency if an authorized generic drug is marketed by clearly 
including this information in annual reports in an easily accessible 
place and by sending a copy of the relevant portion of the annual 
reports to a central contact point. We are taking this action as part 
of our implementation of FDAAA, which

[[Page 37167]]

requires that FDA publish a list of all authorized generic drugs 
included in an annual report after January 1, 1999, and that the agency 
update the list quarterly. We initially published this list on June 27, 
2008, on the Internet and notified relevant Federal agencies that the 
list was published, and we will continue to update it.
    Description of Respondents: Current holders of an NDA under which 
an authorized generic drug was marketed during the time period covered 
by an annual report submitted after January 1, 1999.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
       21 CFR             Number of        Annual frequency       Total annual     Hours per
 314.81(b)(2)(ii)(b)     respondents         per response          responses        response      Total hours
----------------------------------------------------------------------------------------------------------------
Authorized generic                   60                   6.7                400  1 hour                     400
 drug information in
 the first annual
 report submitted
 after the
 implementation of
 Sec.
 314.81(b)(2)(ii)(b)
----------------------------------------------------------------------------------------------------------------
Authorized generic                   60                   6.7                400  15 minutes                 100
 drug information
 submitted in each
 subsequent annual
 report
----------------------------------------------------------------------------------------------------------------
The submission of a                  60                   6.7                400  3 minutes                   20
 copy of that
 portion of each
 annual report
 containing
 authorized generic
 drug information
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    During the past several years, FDA has been reviewing annual 
reports it has received under Sec.  314.81(b)(2) to discern whether an 
authorized generic drug is being marketed by the NDA holder. Based on 
information learned from this review and based on the number of annual 
reports the agency currently receives under Sec.  314.81(b)(2), we 
estimate that, after the implementation of Sec.  314.81(b)(2)(ii)(b), 
we will receive approximately 400 annual reports containing the 
information required under Sec.  314.81(b)(2)(ii)(b) for authorized 
generic drugs that were marketed during the time period covered by an 
annual report submitted after January 1, 1999. Based on the number of 
sponsors that currently submit all annual reports, we estimate that 
approximately 60 sponsors will submit these 400 annual reports with 
authorized generics. As indicated in table 1 of this document, we are 
estimating that the same number of annual reports will be submitted 
each subsequent year from the same number of sponsors containing the 
information required under Sec.  314.81(b)(2)(ii)(b), and that the same 
number of copies of that portion of each annual report containing the 
authorized generic drug information will be submitted from the same 
number of sponsors. Concerning the hours per response, based on our 
estimate of 40 hours to prepare each annual report currently submitted 
under Sec.  314.81(b)(2), we estimate that sponsors will need 
approximately 1 hour to prepare the information required under Sec.  
314.81(b)(2)(ii)(b) for each authorized generic drug that was marketed 
during the time period covered by an annual report submitted after 
January 1, 1999; approximately 15 minutes to prepare the information 
required under Sec.  314.81(b)(2)(ii)(b) for each subsequent annual 
report; and approximately 3 minutes to submit to FDA a copy of that 
portion of each annual report containing the authorized generic drug 
information.
    The information collection provisions of this final rule have been 
submitted to the Office of Management and Budget (OMB) for review, as 
required by section 3507(d) of the PRA. Prior to the effective date of 
this final rule, FDA will publish a notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule. 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.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects 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. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
314 is amended as follows:

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
1. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 
356b, 356c, 371, 374, 379e.

0
2. Section 314.3 is amended in paragraph (b) by alphabetically adding 
the definition for ``authorized generic drug'' to read as follows:

Sec.  314.3   Definitions.

* * * * *
    (b) * * *
    Authorized generic drug means a listed drug, as defined in this 
section, that has been approved under section 505(c) of the act and is 
marketed, sold, or distributed directly or indirectly to retail class 
of trade with labeling, packaging (other than repackaging as the listed 
drug in blister packs, unit doses, or similar packaging for use in 
institutions), product code, labeler code, trade name, or trademark 
that differs from that of the listed drug.
* * * * *

0
3. Section 314.81 is amended by redesignating paragraph (b)(2)(ii) as

[[Page 37168]]

paragraph (b)(2)(ii)(a) and by adding new paragraph (b)(2)(ii)(b) as 
follows:

Sec.  314.81   Other postmarketing reports.

* * * * *
    (b) * * *
    (2) * * *
    (ii) * * *
    (b) Authorized generic drugs. If applicable, the date each 
authorized generic drug (as defined in Sec.  314.3) entered the market, 
the date each authorized generic drug ceased being distributed, and the 
corresponding trade or brand name. Each dosage form and/or strength is 
a different authorized generic drug and should be listed separately. 
The first annual report submitted on or after January 25, 2010 must 
include the information listed in this paragraph for any authorized 
generic drug that was marketed during the time period covered by an 
annual report submitted after January 1, 1999. If information is 
included in the annual report with respect to any authorized generic 
drug, a copy of that portion of the annual report must be sent to the 
Food and Drug Administration, Center for Drug Evaluation and Research, 
Office of New Drug Quality Assessment, Bldg. 21, rm. 2562, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, and marked ``Authorized 
Generic Submission'' or, by e-mail, to the Authorized Generics 
electronic mailbox at AuthorizedGenerics@fda.hhs.gov with ``Authorized 
Generic Submission'' indicated in the subject line. However, at such 
time that FDA has required that annual reports be submitted in an 
electronic format, the information required by this paragraph must be 
submitted as part of the annual report, in the electronic format 
specified for submission of annual reports at that time, and not as a 
separate submission under the preceding sentence in this paragraph.
* * * * *

    Dated: April 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17963 Filed 7-27-09; 8:45 am]

BILLING CODE 4160-01-S