15642 Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 

Title: Revision of the Requirements 

for Constituent Materials. 

Description: The proposed rule would 

permit the Director of CBER or the 

Director of CDER, as appropriate, to 

approve a manufacturer’s request for 

exceptions or alternatives to the 

regulation for constituent materials. 

This proposed rule provides 

manufacturers of biological products 

with flexibility, as appropriate, to 

employ advances in science and 

technology as they become available, 

without diminishing public health 

protections. Manufacturers seeking 

approval of an exception or alternative 

must submit a request in writing. The 

request must be clearly identified with 

a brief statement describing the basis for 

the request and supporting data. The 

request may be submitted as part of the 

original biologics license application, as 

an amendment to the original, pending 

application or as a prior approval 

supplement to an approved application. 

The information to be collected will 

assist FDA in identifying and reviewing 

requests for an exception or alternative 

to the requirements for constituent 

materials. 

Description of Respondents: 

Manufacturers of biological products. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

610.15 3 1 3 1 3 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FDA experience, we 

estimate that we will receive a total of 

approximately 3 requests annually for 

an exception or alternative under 

§ 610.15. The hours per response are 

based on FDA experience with similar 

information collection requirements. 

In compliance with the PRA (44 

U.S.C. 3507(d)), the agency has 

submitted the information collection 

provisions of this proposed rule to OMB 

for review. Interested persons are 

requested to send comments regarding 

information collection to OMB (see 

DATES and ADDRESSES). 

VI. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 610 

Biologics, Labeling, Reporting and 

Recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, it is proposed that 21 CFR 

part 610 be amended as follows: 

PART 610—GENERAL BIOLOGICAL 

PRODUCTS STANDARDS 

1. The authority citation for 21 CFR 

part 610 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360c, 360d, 360h, 360i, 371, 

372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 

264. 

2. Amend § 610.15 by adding new 

paragraph (d) to read as follows: 

§ 610.15 Constituent materials. 

* * * * * 

(d) The Director of the Center for 

Biologics Evaluation and Research or 

the Director of the Center for Drug 

Evaluation and Research may approve 

an exception or alternative to any 

requirement in this section. Requests for 

such exceptions or alternatives must be 

in writing. 

Dated: March 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–7073 Filed 3–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–335P] 

RIN 1117–AB28 

Schedules of Controlled Substances: 

Exempted Prescription Product; River 

Edge Pharmaceutical, Servira 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This Notice of Proposed 

Rulemaking proposes the amendment of 

the list of Exempted Prescription 

Products cited in the Code of Federal 

Regulations. This action is in response 

to DEA’s review of new applications for 

exemption. DEA has received one new 

application for exemption for River 

Edge Pharmaceutical’s Servira®. Having 

reviewed this application and relevant 

information, DEA finds that this 

preparation has no significant potential 

for abuse. Therefore, DEA hereby 

proposes that this product be added to 

the list of Exempted Prescription 

Products and exempted from the 

application of certain provisions of the 

Controlled Substances Act (CSA). 

DATES: Written comments must be 

postmarked and electronic comments 

must be submitted on or before April 29, 

2010. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after Midnight Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–335’’ on all written and 

electronic correspondence. Written 

comments sent via regular or express 

mail should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, VA 22152. Comments may 

be sent to DEA by sending an electronic 

message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the 

http://www.regulations.gov Web site. 

DEA will accept attachments to 

electronic comments in Microsoft word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file formats other than those specifically 

listed here. 

Please note that DEA is requesting 

that electronic comments be submitted 

before midnight Eastern time on the day 

the comment period closes because 

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Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 15643 

http://www.regulations.gov terminates 

the public’s ability to submit comments 

at midnight Eastern time on the day the 

comment period closes. Commenters in 

time zones other than Eastern time may 

want to consider this so that their 

electronic comments are received. All 

comments sent via regular or express 

mail will be considered timely if 

postmarked on the day the comment 

period closes. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, Ph.D., 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: 

Posting of Public Comments: Please 

note that all comments received are 

considered part of the public record and 

made available for public inspection 

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

Such information includes personal 

identifying information (such as your 

name, address, etc.) voluntarily 

submitted by the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted on http:// 

www.regulations.gov. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the Drug Enforcement 

Administration’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION CONTACT

paragraph. 

Background 

The Controlled Substances Act as 

amended by the Dangerous Drug 

Diversion Control Act of 1984 

authorizes the Attorney General in 

accordance with 21 U.S.C. 811(g)(3)(A) 

to exempt from specific provisions of 

the Act, a preparation or mixture if that 

preparation or mixture: (1) Contains a 

nonnarcotic controlled substance; (2) is 

approved for prescription use; and (3) 

contains one or more active ingredients 

that are not listed in any schedule and 

whose presence vitiates the potential for 

abuse of the nonnarcotic controlled 

substance. Such exemptions apply only 

to a specific prescription product and 

are only granted following suitable 

application to the Drug Enforcement 

Administration per 21 CFR 1308.31. 

Exemption of Nonnarcotic Prescription 

Products 

21 CFR 1308.31 provides an 

application procedure whereby any 

person may apply for exemption for 

nonnarcotic prescription products 

which meet certain criteria. 21 CFR 

1308.31(a) further states that any person 

seeking to have any compound, mixture, 

or preparation containing any 

nonnarcotic controlled substance listed 

in 21 CFR 1308.12(e), or in 21 CFR 

1308.13(b) or (c), or in 21 CFR 1308.14, 

or in 21 CFR 1308.15, exempted from 

application of all or any part of the CSA 

pursuant to 21 U.S.C. 811(g)(3)(A) may 

apply to the Administrator of DEA for 

such exemption. 

21 CFR 1308.31(b) specifies that an 

application for an exemption shall 

contain the following information: 

(1) The complete quantitative 

composition of the dosage form. 

(2) Description of the unit dosage 

form together with complete labeling. 

(3) A summary of the pharmacology of 

the product including animal 

investigations and clinical evaluations 

and studies, with emphasis on the 

psychic and/or physiological 

dependence liability (this must be done 

for each of the active ingredients 

separately and for the combination 

product). 

(4) Details of synergisms and 

antagonisms among ingredients. 

(5) Deterrent effects of the 

noncontrolled ingredients. 

(6) Complete copies of all literature in 

support of claims. 

(7) Reported instances of abuse. 

(8) Reported and anticipated adverse 

effects. 

(9) Number of dosage units produced 

for the past 2 years. 

Within a reasonable period of time 

after the receipt of an application for an 

exemption under this section, 21 CFR 

1308.31(c) states that the Administrator 

shall notify the applicant of the 

acceptance or non-acceptance of the 

application, and if not accepted, the 

reason therefor. The regulation states 

that the Administrator need not accept 

an application for filing if any of the 

requirements prescribed in 21 CFR 

1308.31(b) is lacking or is not set forth 

so as to be readily understood. The 

regulation states that if accepted for 

filing, the Administrator shall publish 

in the Federal Register a general notice 

of proposed rulemaking in granting or 

denying the application. Such notice 

shall include a reference to the legal 

authority under which the rule is 

proposed, a statement of the proposed 

rule granting or denying an exemption, 

and, in the discretion of the 

Administrator, a summary of the 

subjects and issues involved. 

The regulation further specifies that 

the Administrator shall permit any 

interested person to file written 

comments on or objections to the 

proposal and shall designate in the 

notice of proposed rulemaking the time 

during which such filings may be made. 

After consideration of the application 

and any comments on or objections to 

the proposed rulemaking, the 

Administrator shall issue and publish in 

the Federal Register a final order on the 

application, which shall set forth the 

findings of fact and conclusions of law 

upon which the order is based. This 

order shall specify the date on which it 

shall take effect, which shall not be less 

than 30 days from the date of 

publication in the Federal Register 

unless the Administrator finds that 

conditions of public health or safety 

necessitate an earlier effective date, in 

which event the Administrator shall 

specify in the order his findings as to 

such conditions. 

21 CFR 1308.31(d) further states that 

the Administrator may revoke any 

exemption granted pursuant to 21 

U.S.C. 811(g)(3)(A) by following the 

procedures set forth in 21 CFR 

1308.31(c). 

Redelegation of Authority 

The Administrator has redelegated 

this authority to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, pursuant to 28 CFR 

0.104, Appendix to Subpart R. The 

current Table of Exempted Prescription 

Products lists those products that have 

been granted exempt status prior to this 

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15644 Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 

update. That table can be viewed online 

at: http://www.deadiversion.usdoj.gov/ 

schedules/exempt/exempt_list.htm. 

Product Exemptions Subject to This 

Proposed Rulemaking 

DEA received one application for 

exemption pursuant to the provisions of 

21 CFR 1308.32 for: 

River Edge Pharmaceutical’s Servira®

(NDC Code 68032–256) tablets 

containing 48.6 mg phenobarbital in 

combination with hyoscyamine sulfate, 

atropine sulfate and scopolamine 

hydrobromide. 

The Deputy Assistant Administrator, 

Office of Diversion Control, having 

reviewed this application and relevant 

information, finds that this preparation 

contains a nonnarcotic controlled 

substance listed in 21 CFR 1308.14, also 

contains an active ingredient not listed 

in any controlled substance schedule, 

and has no significant potential for 

abuse. 

The product Servira® contains the 

drug phenobarbital. Phenobarbital is a 

schedule IV controlled substance listed 

in 21 CFR 1308.14. The product also 

contains the anticholinergic ingredients 

hyoscyamine sulfate, atropine sulfate 

and scopolamine hydrobromide. These 

ingredients are not controlled 

substances. In the quantities included in 

the product, these ingredients have 

deterrent effects upon the product’s 

potential for abuse. 

Therefore, the Deputy Assistant 

Administrator hereby proposes that the 

following product is to be exempted 

from the application of sections 302 

through 305, 307 through 309, and 1002 

through 1004 of the Act (21 U.S.C. 822– 

825, 827–829, and 952–954) and 

§§ 1301.13, 1301.22, and 1301.71 

through 1301.77 of this chapter. If this 

rule is finalized as proposed, the table 

that is available online will be updated 

to include the exempted prescription 

product included in this rulemaking. 

Any interested person may file 

written comments or objections to this 

proposal. After consideration of the 

application and any comments or 

objections to the proposed rulemaking, 

the Deputy Assistant Administrator 

shall issue and publish in the Federal 

Register the final order of the 

application. The Deputy Assistant 

Administrator may revoke any 

exemption granted pursuant to 21 

U.S.C. 811(g)(3)(A) by following the 

procedures set forth in 21 CFR 

1308.31(c). 

Regulatory Certifications 

Regulatory Flexibility Act 

The Deputy Assistant Administrator 

hereby certifies that this rulemaking has 

been drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and by approving it certifies 

that this regulation will not have a 

significant economic impact upon a 

substantial number of small entities. 

This regulation will not have a 

significant impact upon firms who 

distribute these products. In fact, the 

approval of Exempted Prescription 

status for these products reduces the 

regulatory requirements for distribution 

of these materials. 

Executive Order 12866 

The Deputy Assistant Administrator 

further certifies that this rulemaking has 

been drafted in accordance with the 

principles of Executive Order 12866 

Section 1(b). It has been determined that 

this is not a significant regulatory 

action. Therefore, this action has not 

been reviewed by the Office of 

Management and Budget. 

Executive Order 12988 

The Deputy Assistant Administrator 

further certifies that this regulation 

meets the applicable standards set forth 

in Sections 3(a) and 3(b)(2) of Executive 

Order 12988. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of State law; nor 

does it impose enforcement 

responsibilities on any State; nor does it 

diminish the power of any State to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 

1995 

This rule will not result in the 

expenditure by State, local and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by Section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

Under the authority vested in the 

Attorney General by section 202(d) of 

the Act (21 U.S.C. 811(g)(3)(B)) and 

delegated to the Administrator of the 

Drug Enforcement Administration by 

regulations of the Department of Justice 

(28 CFR Part 0.100), and redelegated to 

the Deputy Assistant Administrator, 

Office of Diversion Control, Drug 

Enforcement Administration, the 

Deputy Assistant Administrator hereby 

proposes to amend the Table of 

Exempted Prescription Products cited in 

§ 1308.32 by adding the following: 

Company Trade name NDC code Form Controlled substance (mg or 

mg/ml) 

River’s Edge Pharmaceutical ....... Servira ........................................ 68032–256 TB ........... Phenobarbital .............................. 48.6 

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Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 15645 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

Dated: March 12, 2010. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2010–6035 Filed 3–29–10; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2010–0147; FRL–9130–4] 

Approval and Promulgation of Air 

Quality Implementation Plans; Texas; 

Revisions to the Emission Credit 

Banking and Trading Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

severable portions of two revisions to 

the Texas State Implementation Plan 

(SIP) submitted by the State of Texas on 

October 24, 2006, and August 16, 2007. 

These revisions amend existing sections 

and create a new section in Title 30 of 

the Texas Administrative Code (TAC), 

Chapter 101—General Air Quality 

Rules, Subchapter H—Emissions 

Banking and Trading, Division 1— 

Emission Credit Banking and Trading, 

referred to elsewhere in this notice as 

the Emission Reduction Credit (ERC) 

Program. The October 24, 2006, 

submittal creates a new section for 

international emission reduction 

provisions and amends existing sections 

to further clarify procedures for using 

emission protocols and to update the 

approved list of emission credit uses. 

The August 16, 2007, submittal amends 

two sections of the ERC program to 

update cross-references to recently 

recodified 30 TAC Chapter 117 

provisions. EPA has determined that 

these SIP revisions comply with the 

Clean Air Act and EPA regulations, are 

consistent with EPA policies, and will 

improve air quality. This action is being 

taken under section 110 and parts C and 

D of the Federal Clean Air Act (the Act 

or CAA). 

DATES: Comments must be received on 

or before April 29, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R06– 

OAR–2010–0147, by one of the 

following methods: 

(1) http://www.regulations.gov: 

Follow the on-line instructions for 

submitting comments. 

(2) E-mail: Mr. Jeff Robinson at 

robinson.jeffrey@epa.gov. Please also cc 

the person listed in the FOR FURTHER

INFORMATION CONTACT paragraph below. 

(3) U.S. EPA Region 6 ‘‘Contact Us’’ 

Web site: http://epa.gov/region6/ 

r6coment.htm. Please click on ‘‘6PD’’ 

(Multimedia) and select ‘‘Air’’ before 

submitting comments. 

(4) Fax: Mr. Jeff Robinson, Chief, Air 

Permits Section (6PD–R), at fax number 

214–665–6762. 

(5) Mail: Mr. Jeff Robinson, Chief, Air 

Permits Section (6PD–R), Environmental 

Protection Agency, 1445 Ross Avenue, 

Suite 1200, Dallas, Texas 75202–2733. 

(6) Hand or Courier Delivery: Mr. Jeff 

Robinson, Chief, Air Permits Section 

(6PD–R), Environmental Protection 

Agency, 1445 Ross Avenue, Suite 1200, 

Dallas, Texas 75202–2733. Such 

deliveries are accepted only between the 

hours of 8:30 a.m. and 4:30 p.m. 

weekdays except for legal holidays. 

Special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R06–OAR–2010– 

0147. 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 

the disclosure of which is restricted by 

statute. Do not submit information 

through http://www.regulations.gov or 

e-mail, if you believe that it is CBI or 

otherwise protected from disclosure. 

The http://www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means that 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 along with any disk or CD– 

ROM submitted. 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 and any form of encryption 

and should 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 docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information the disclosure of which is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available either 

electronically in http:// 

www.regulations.gov or in hard copy at 

the Air Permits Section (6PD–R), 

Environmental Protection Agency, 1445 

Ross Avenue, Suite 700, Dallas, Texas 

75202–2733. The file will be made 

available by appointment for public 

inspection in the Region 6 FOIA Review 

Room between the hours of 8:30 a.m. 

and 4:30 p.m. weekdays except for legal 

holidays. Contact the person listed in 

the FOR FURTHER INFORMATION CONTACT

paragraph below to make an 

appointment. If possible, please make 

the appointment at least two working 

days in advance of your visit. A 15 cent 

per page fee will be charged for making 

photocopies of documents. On the day 

of the visit, please check in at the EPA 

Region 6 reception area on the seventh 

floor at 1445 Ross Avenue, Suite 700, 

Dallas, Texas. 

The State submittal related to this SIP 

revision, and which is part of the EPA 

docket, is also available for public 

inspection at the State Air Agency listed 

below during official business hours by 

appointment: 

Texas Commission on Environmental 

Quality, Office of Air Quality, 12124 

Park 35 Circle, Austin, Texas 78753. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions concerning today’s 

proposed rule, please contact Ms. Adina 

Wiley (6PD–R), Air Permits Section, 

Environmental Protection Agency, 

Region 6, 1445 Ross Avenue (6PD–R), 

Suite 1200, Dallas, TX 75202–2733. The 

telephone number is (214) 665–2115. 

Ms. Wiley can also be reached via 

electronic mail at wiley.adina@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document wherever, 

any reference to ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is 

used, we mean EPA. 

Table of Contents 

I. What Action Is EPA Taking? 

II. What Did Texas Submit? 

III. What Is EPA’s Evaluation of These SIP 

Revisions? 

IV. Final Action 

V. Statutory and Executive Order Reviews 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS