Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 56529 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket No. FAA–2008–0757/Airspace 

Docket No. 08–ASW–13.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

Availability of NPRM’s 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s Web page at http:// 

www.faa.gov or the Superintendent of 

Document’s Web page at http:// 

www.access.gpo.gov/nara. 

Additionally, any person may obtain 

a copy of this notice by submitting a 

request to the Federal Aviation 

Administration (FAA), Office of Air 

Traffic Airspace Management, ATA– 

400, 800 Independence Avenue, SW., 

Washington, DC 20591, or by calling 

(202) 267–8783. Communications must 

identify both docket numbers for this 

notice. Persons interested in being 

placed on a mailing list for future 

NPRM’s should contact the FAA’s 

Office of Rulemaking (202) 267–9677, to 

request a copy of Advisory Circular No. 

11–2A, Notice of Proposed Rulemaking 

Distribution System, which describes 

the application procedure. 

The Proposal 

This action proposes to amend Title 

14, Code of Federal Regulations (14 

CFR), Part 71 by amending the Class E 

airspace area for IFR operations at Big 

Spring McMahon-Wrinkle Airport, Big 

Spring, TX. Changes to the VOR/DME 

RWY 17 SIAP have made this action 

necessary. The area would be depicted 

on appropriate aeronautical charts. 

Class E airspace areas are published 

in Paragraph 6000 of FAA Order 

7400.9R, dated August 15, 2007, and 

effective September 15, 2007, which is 

incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document would be 

published subsequently in the Order. 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore, (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 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. 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 would 

amend controlled airspace at Big Spring 

McMahon-Wrinkle Airport, Big Spring, 

TX. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (Air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; 

AIRWAYS; ROUTES; AND REPORTING 

POINTS 

1. The authority citation for 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 71.1 of Federal Aviation 

Administration Order 7400.9R, Airspace 

Designations and Reporting Points, 

dated August 15, 2007, and effective 

September 15, 2007, is amended as 

follows: 

Paragraph 6005 Class E Airspace areas 

extending upward from 700′ or more above 

the surface of the earth. 

* * * * * 

ASW TX E5 Big Spring, TX [Amended] 

Big Spring McMahon-Wrinkle Airport, TX 

(Lat. 32°12′45′′ N., long. 101°31′18′′ W.) 

Big Spring VORTAC 

(Lat. 32°23′08′′ N., long. 101°29′01′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.9-mile 

radius of Big Spring McMahon-Wrinkle 

Airport and within 8 miles east and 4 miles 

west of the 190° radial of the Big Spring 

VORTAC extending from the 6.9-mile radius 

to 21.9 miles south of the airport and within 

3.9 miles each side of the 191° radial of the 

Big Spring VORTAC extending from the 6.9- 

mile radius to 10.3 miles north of the airport. 

* * * * * 

Issued in Fort Worth, TX, on August 28, 

2008. 

Roger M. Trevino, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. E8–22448 Filed 9–26–08; 8:45 am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 314 

[Docket No. FDA–2008–N–0341] 

Applications for Food and Drug 

Administration Approval to Market a 

New Drug; Postmarketing Reports; 

Reporting Information About 

Authorized Generic Drugs; Companion 

Document to Direct Final Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing this 

companion proposed rule to the direct 

final rule, published elsewhere in this 

issue of the Federal Register, which is 

intended to amend our regulations to 

require that the holder of a new drug 

application (NDA) submit certain 

information in an annual report 

regarding authorized generic drugs. 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: Submit written or electronic 

comments on the proposed rule by 

December 15, 2008. If FDA receives any 

significant adverse comments, the 

agency will publish a document 

withdrawing the direct final rule within 

30 days after the comment period ends. 

FDA will then proceed to respond to 

comments under this proposed rule 

using the usual notice and comment 

procedures. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

October 29, 2008 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 


hsrobinson on PROD1PC76 with PROPOSALS
56530 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N– 

0341, by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), 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. 6223, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As described more fully in the direct 

final rule, FDAAA requires that FDA 

take the following actions: (1) 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; (2) update the list 

quarterly; and (3) notify relevant Federal 

agencies that the list has been published 

and will be updated quarterly. For 

purposes of publishing the list, section 

505(t)(3) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 355(t)) 

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.’’ 

We are proposing to amend § 314.3 

(21 CFR 314.3) of our regulations by 

adding a definition of ‘‘authorized 

generic drug.’’ 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 are proposing to 

amend § 314.81 (21 CFR 314.81) by 

adding paragraph (b)(2)(ii)(b), which 

would require that annual reports 

specifically and clearly include the 

information we are required to report. In 

addition, we propose to require 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. When information 

is included in an annual report about an 

authorized generic drug, we would 

require that a copy of that portion of the 

annual report be sent to a central office 

in the agency that will compile the list 

and update it quarterly. This proposed 

rule assumes that the copy of the 

relevant portion of the annual report 

may currently be submitted in any 

number of formats (e.g., a paper copy, a 

PDF document on a computer disc). 

Current capabilities do not permit direct 

electronic submission through a Webbased system. However, FDA is 

committed to adapting its business 

practices to evolving technology, 

including using the significant 

advancements in Web-based, electronic 

systems. We anticipate that, in future 

rulemakings, Web-based submission of 

annual reports will eventually be 

required. In anticipation of that future 

change, this proposed rule provides that 

once an electronic submission format is 

adopted for annual reports, the 

submission to the agency of the 

information required under this 

regulation will also be required in that 

electronic format. We anticipate that 

when such a change is implemented, 

future guidance will address any 

technical questions related to such 

submissions. 

II. Additional Information 

This proposed rule is a companion to 

the direct final rule published elsewhere 

in this issue of the Federal Register. 

This companion proposed rule and the 

direct final rule are identical in 

substance. This companion proposed 

rule will provide the procedural 

framework to proceed with standard 

notice-and-comment rulemaking in the 

event the direct final rule receives 

significant adverse comment and is 

withdrawn. The comment period for the 

companion proposed rule runs 

concurrently with the comment period 

of the direct final rule. Any comments 

received under the companion proposed 

rule will be treated as comments 

regarding the direct final rule and vice 

versa. 

A significant adverse comment is one 

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 change. A 

comment recommending a rule change 

in addition to this rule will not be 

considered a significant adverse 

comment unless the comment states 

why this rule would be ineffective 

without the additional change. 

If no significant adverse comment is 

received in response to the direct final 

rule, no further action will be taken 

related to the companion proposed rule. 

Instead, we will publish a confirmation 

notice within 30 days after the comment 

period ends. We intend the direct final 

rule to become effective 30 days after 

publication of the confirmation notice. 

If we receive significant adverse 

comments, we will withdraw the direct 

final rule. We will proceed to respond 

to all the comments received regarding 

the direct final rule, treating those 

comments as comments to this proposed 

rule. The agency will address the 

comments in the subsequent final rule. 

We will not provide additional 

opportunity for comment. If we receive 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 56531 

a significant adverse comment which 

applies to part of the rule and that part 

may be severed from the remainder of 

the rule, we may adopt as final those 

parts of the rule that are not the subject 

of significant adverse comment. 

For additional background 

information, see the corresponding 

direct final rule published elsewhere in 

this issue of the Federal Register. All 

persons who may wish to comment 

should review the complete rationale for 

this amendment set out in the preamble 

of the direct final rule. 

III. Environmental Impact 

We have carefully considered, under 

21 CFR part 25, the potential 

environmental effects of this action. We 

have concluded that this action will not 

have a significant impact on the human 

environment and that an environmental 

impact statement is not required. 

IV. Analysis of Impacts 

FDA has examined the impacts of the 

proposed 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 proposed rule is not a 

significant regulatory action as defined 

by 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 proposed rule 

imposes only minimal regulatory 

obligations, the agency certifies that the 

proposed 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 proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

The only costs of this proposed rule 

are associated with the Paperwork 

Reduction Act burden, described in 

section V 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). 

V. The Paperwork Reduction Act of 

1995 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). A description of 

these provisions is given 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. 

FDA invites comments on the 

following: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 office. We are 

taking this action as part of our 

implementation of FDAAA, which 

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 plan to publish this list on the 

Internet and to notify relevant Federal 

agencies that the list has been published 

and will be updated. 

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. 


hsrobinson on PROD1PC76 with PROPOSALS
56532 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 

1 During fiscal year 2006, the Center for Drug 

Evaluation and Research received 2,569 annual 

reports under § 314.81(b)(2) from 374 sponsors.) 

2See the Federal Register of January 4, 2008 (73 

FR 865). 

During the past several years, FDA 

has reviewed a small sample of 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),1 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),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 proposed rule have been 

submitted to OMB for review. Interested 

persons are requested to fax comments 

regarding information collection by 

October 29, 2008, to the Office of 

Information and Regulatory Affairs, 

OMB. To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

VI. Legal Authority 

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA), provides 

authority for FDA to issue this proposed 

rule. Section 505(t) of the act (21 U.S.C. 

355(t); FDAAA section 920) 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 proposed rule would 

amend FDA’s existing regulations 

regarding annual reports in order to 

ensure that the information necessary 

for the agency to fulfill its obligation 

under section 505(t) is clearly reported. 

VII. Federalism 

FDA has analyzed this proposed 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. 

VIII. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

This comment period runs concurrently 

with the comment period for the direct 

final rule; any comments received will 

be considered as comments regarding 

the direct final rule. Submit a single 

copy of electronic comments or two 

paper copies of any mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

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, it is proposed that 

21 CFR part 314 be 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 adding the following 

definition for authorized generic drug in 

alphabetical order: 

§ 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 trade mark that differs 

from that of the listed drug. 

* * * * * 

3. Section 314.81 is amended by 

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

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 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 56533 

1Three of the commenters that supported the rule 

also said, in somewhat different ways, that the 

proposed rule should go further—for example, by 

also transferring marijuana and/or its derivatives 

out of schedule I or by granting a pending 

application by a person seeking to become 

registered to manufacture marijuana. 

2This commenter suggested that all forms of THC 

should either be in schedule I or schedule III, but 

that FDA-approved formulations containing THC 

should not be listed separately from illicit forms of 

the drug. 

3For a discussion of the formal rescheduling 

procedures under the CSA, see Gettman v. DEA, 

290 F.3d at 430, 432 (D.C. Cir. 2002). 

submitted on or after February 11, 2009, 

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 Pharmaceutical Science, 10903 

New Hampshire Ave., Bldg. 51, rm. 

4183, Silver Spring, MD 20993–0002 

and marked ‘‘Authorized Generic 

Submission’’ or, if FDA has required 

that annual reports be submitted in an 

electronic format, the information 

required by this section must also be 

submitted in the electronic format. 

* * * * * 

Dated: September 16, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22829 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–308W] 

Technical Amendment to Listing in 

Schedule III of Approved Drug 

Products Containing 

Tetrahydrocannabinols; Withdrawal of 

Proposed Rule 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice 

ACTION: Withdrawal of proposed rule. 

SUMMARY: DEA is withdrawing a 

proposed rule that was published in the 

Federal Register on September 24, 2007 

(72 FR 54226) and is terminating the 

rulemaking. The proposed rule would 

have revised the DEA regulations with 

respect to the listing in schedule III of 

a synthetic isomer of 

tetrahydrocannabinols (THC) contained 

in a specific formulation of a drug 

product approved by the U.S. Food and 

Drug Administration (FDA). 

Specifically, the proposed rule would 

have revised the DEA regulation so that 

it would also include generic drug 

products approved by the FDA under 

section 505(j) of the Food, Drug, and 

Cosmetic Act (FDCA) (21 U.S.C. 355) 

that cite the drug product currently 

listed in schedule III as the reference 

listed drug. In view of the comments 

DEA received in response to the 

proposed rule, DEA has decided—in 

lieu of finalizing the proposed rule—to 

proceed with the process set out in 21 

U.S.C. 811 for transferring each such 

generic drug individually to schedule 

III. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD., Chief, 

Drug and Chemical Evaluation Section, 

Office of Diversion Control, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, VA 

22152; Telephone: (202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Under the Controlled Substances Act 

(CSA), the schedules of controlled 

substances are published on an updated 

basis in the DEA regulations. 21 U.S.C. 

812(a), (c) and n.1. Currently, one of the 

substances listed in schedule III is the 

following: ‘‘Dronabinol (synthetic) in 

sesame oil and encapsulated in a soft 

gelatin capsule in a U.S. Food and Drug 

Administration [FDA] approved 

product.’’ 21 CFR 1308.13(g)(1). This 

describes the drug product marketed 

under the brand name Marinol. As 

explained in the Notice of Proposed 

Rulemaking (NPRM) (72 FR 54226), it is 

possible that generic versions of Marinol 

could be approved by the FDA yet not 

fit within the same schedule III listing 

as Marinol. The proposed rule was 

intended to correct this situation so that 

certain generic versions of Marinol that 

might be approved by the FDA in the 

future would be in the same schedule as 

Marinol. 

During the comment period, DEA 

received comments from nine entities 

(firms, organizations, and one 

individual). Six of the nine commenters 

expressed support for the proposed 

rule,1 two opposed it, and one stated 

both that it was ‘‘a good idea’’ and ‘‘not 

a good idea.’’ 2 One of the commenters 

that opposed the rule asserted that the 

rule was not in conformity with the 

CSA. Specifically, this commenter 

asserted that, to achieve the intended 

result of the rule (transferring to 

schedule III any future FDA-approved 

generic versions of Marinol that do not 

fit within the current wording of 21 CFR 

1308.13(g)(1)), DEA must engage in 

formal rescheduling action, following 

the procedures set forth in 21 U.S.C. 

811. Under these procedures, DEA 

requests from the Department of Health 

and Human Services (HHS) a scientific 

and medical evaluation and scheduling 

recommendation, with DEA and HHS 

being required to consider the eight 

factors set forth in 21 U.S.C. 811(b).3 In 

addition, both of the commenters that 

objected to the proposed rule asserted 

that the unique formulation of Marinol 

(that which meets the current wording 

of 21 CFR 1308.13(g)(1)) prevents the 

drug from having the ‘‘high potential for 

abuse’’ commensurate with controlled 

substances in schedules I and II. 

Further, these commenters asserted, 

generic versions of Marinol that might 

be approved by the FDA in the future 

cannot be assumed to have the same 

potential for abuse as Marinol if they 

were to differ from Marinol in their 

formulations or routes of 

administration. Based on these 

considerations, one of the objecting 

commenters asked that DEA withdraw 

the proposed rule or, in the alternative, 

grant an administrative hearing to 

address the issues raised in its 

objections. 

In the NPRM (in the preamble to the 

proposed rule), DEA addressed the 

foregoing legal and factual issues raised 

by the objecting commenters. Having 

considered the comments, DEA 

continues to believe that the proposed 

rule is legally permissible within the 

structure of the CSA, for the reasons set 

forth in the NPRM. In addition, having 

obtained the input and concurrence of 

the FDA during the development of the 

proposed rule, DEA believes that the 

proposed rule accurately reflects the 

relevant legal considerations under the 

FDCA and further that it is grounded in 

sound scientific considerations. It 

should also be noted that two of the 

commenters that supported the rule 

agreed with DEA regarding the core 

legal and factual issues raised by those 

commenters that objected to the rule. 

Nonetheless, DEA must consider what 

would likely be the practical realities of 

going forward with the proposed rule at 

this time. 

First, if DEA were to grant the 

objecting commenter’s request for a 

hearing, the administrative proceedings 

within the agency would likely take at 

least two years to complete, taking into 

account the time to conduct the hearing 

presided over by an administrative law 

judge (ALJ), the issuance by the ALJ of 

a recommended decision, and the 


hsrobinson on PROD1PC76 with PROPOSALS