Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Rules and Regulations 37163 

FAA found that the cite for the Class E2 

airspace was omitted. With the 

exception of editorial changes, and the 

changes described above, this rule is the 

same as that proposed in the NPRM. 

The Rule 

This action amends Title 14 Code of 

Federal Regulations (14 CFR) part 71 by 

amending Class E airspace at Ankeny, 

IA, reconfiguring controlled airspace at 

Ankeny Regional Airport, Ankeny, IA, 

for the safety and management of IFR 

operations. This action also updates the 

geographic coordinates of the airport to 

coincide with the FAA’s National 

Aeronautical Charting Office. This rule 

also cites the correct paragraph in which 

the Class E2 airspace is found in FAA 

Order 7400.9S. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the U.S. Code. Subtitle 1, 

Section 106, describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the agency’s 

authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it amends 

controlled airspace at Ankeny Regional 

Airport, Ankeny, IA. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR Part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

Part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR Part 71.1 of the Federal Aviation 

Administration Order 7400.9S, Airspace 

Designations and Reporting Points, 

signed October 3, 2008, and effective 

October 31, 2008, is amended as 

follows: 

Paragraph 6002 Class E airspace designated 

as surface areas. 

* * * * * 

ACE IA E2 Ankeny, IA [Amended] 

Ankeny Regional Airport, IA 

(Lat. 41°41′29′′ N., long. 93°33′59′′ W.) 

Within a 4-mile radius of Ankeny Regional 

Airport, excluding that portion within the 

Des Moines Class C airspace area. 

* * * * * 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface. 

* * * * * 

ACE IA E5 Ankeny, IA [Amended] 

Ankeny Regional Airport, IA 

(Lat. 41°41′29′′ N., long. 93°33′59′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 7.1-mile 

radius of Ankeny Regional Airport, and 

within 2 miles each side of the 045° bearing 

from the airport extending from the 7.1-mile 

radius to 9.3 miles northeast of the airport, 

and within 2 miles each side of the 012° 

bearing from the airport extending from the 

7.1-mile radius to 11.1 miles north of the 

airport, excluding that portion within the Des 

Moines Class C airspace area. 

* * * * * 

Issued in Fort Worth, Texas, on July 16, 

2009. 

Anthony D. Roetzel, 

Manager, Operations Support Group, ATO 

Central Service Center. 

[FR Doc. E9–17863 Filed 7–27–09; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 § 314.3 (21 

CFR 314.3) to add a definition of 

‘‘authorized generic drug’’ and § 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 


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37164 Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Rules and Regulations 

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 noticeand-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 

§ 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 § 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 

§ 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 § 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 § 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 § 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 


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Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Rules and Regulations 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 

§ 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 

§ 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 § 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, 

§ 314.81(b)(2)(ii) is renumbered as 

§ 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 longstanding 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 

§ 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 

§ 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 


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37166 Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Rules and Regulations 

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 § 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 × 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 


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Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Rules and Regulations 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 BURDEN1

21 CFR 314.81(b)(2)(ii)(b) Number of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Authorized generic drug information 

in the first annual report submitted after the implementation of 

§ 314.81(b)(2)(ii)(b) 

60 6.7 400 1 hour 400 

Authorized generic drug information 

submitted in each subsequent 

annual report 

60 6.7 400 15 minutes 100 

The submission of a copy of that 

portion of each annual report 

containing authorized generic 

drug information 

60 6.7 400 3 minutes 20 

1There 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 § 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 § 314.81(b)(2), we 

estimate that, after the implementation 

of § 314.81(b)(2)(ii)(b), we will receive 

approximately 400 annual reports 

containing the information required 

under § 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 § 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 

§ 314.81(b)(2), we estimate that sponsors 

will need approximately 1 hour to 

prepare the information required under 

§ 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 

§ 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. 

■ 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 

■ 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. 

■ 2. Section 314.3 is amended in 

paragraph (b) by alphabetically adding 

the definition for ‘‘authorized generic 

drug’’ to read as follows: 

§ 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. 

* * * * * 

■ 3. Section 314.81 is amended by 

redesignating paragraph (b)(2)(ii) as 


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37168 Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Rules and Regulations 

paragraph (b)(2)(ii)(a) and by adding 

new paragraph (b)(2)(ii)(b) as follows: 

§ 314.81 Other postmarketing reports. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) * * * 

(b) Authorized generic drugs. If 

applicable, the date each authorized 

generic drug (as defined in § 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2009–0303(a); FRL–8936– 

2] 

Approval and Promulgation of 

Implementation Plans; South Carolina; 

Transportation Conformity 

Memorandum of Agreement Update 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve a revision to the South 

Carolina State Implementation Plan 

(SIP) submitted on November 28, 2008, 

through the South Carolina Department 

of Health and Environmental Control 

(SC DHEC). This revision consists of 

transportation conformity criteria and 

procedures related to interagency 

consultation and enforceability of 

certain transportation-related control 

measures and mitigation measures. The 

intended effect of this approval is to 

update the transportation conformity 

criteria and procedures in the South 

Carolina SIP. 

DATES: This direct final rule is effective 

September 28, 2009 without further 

notice, unless EPA receives adverse 

comment by August 27, 2009. If EPA 

receives such comments, it will publish 

a timely withdrawal of the direct final 

rule in the Federal Register and inform 

the public that the rule will not take 

effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2009–0303, by one of the 

following methods: 

a. http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

b. E-mail: Wood.amanetta@epa.gov. 

c. Fax: (404) 562–9019. 

d. Mail: EPA–R04–OAR–2009–0303, 

Air Quality Modeling and 

Transportation Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. 

e. Hand Delivery or Courier: Amanetta 

Wood, Air Quality Modeling and 

Transportation Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. Such 

deliveries are only accepted during the 

Regional Office’s normal hours of 

operation. The Regional Office’s official 

hours of business are Monday through 

Friday, 8:30 to 4:30, excluding Federal 

holidays. 

Instructions: Direct your comments to 

Docket ID No. EPA–R04–OAR–2009– 

0303. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online 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 through http:// 

www.regulations.gov or e-mail, 

information that you consider to be CBI 

or otherwise protected. 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. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the 

electronic docket are listed in the 

http://www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in http:// 

www.regulations.gov or in hard copy at 

the Air Quality Modeling and 

Transportation Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. EPA 


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