14538 Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 

The establishment will not be 

considered active and the establishment 

registration and device listing 

information will not appear on the FDA 

Web site until the required information 

is submitted to and processed by FDA. 

15. Amend § 807.35 by revising 

paragraphs (a) and (b) to read as follows: 

§ 807.35 Notification of registrant. 

(a) FDA will assign each device 

establishment a permanent registration 

number after verifying the initial 

establishment registration information 

that has been submitted. The owner or 

operator of the establishment will also 

be assigned an identifying number. Both 

numbers will be sent to the official 

correspondent by e-mail, or by postal 

mail if the owner or operator has been 

granted a waiver from the requirement 

to file registration and listing 

information electronically. 

(b) Owners or operators of device 

establishments who also manufacture or 

process biological products (including 

devices licensed under section 351 of 

the Public Health Service Act) or drug 

products at the same establishment 

must also register and list those 

products under part 607 or part 207 of 

this chapter, as appropriate. Registration 

and listing for human blood and blood 

products, devices licensed under 

section 351 of the Public Health Service 

Act, and licensed biological products 

used in the manufacture of a device 

licensed under section 351 of the Public 

Health Service Act, are subject to part 

607 of this chapter; registration and 

listing for all other drug products 

(including other biological products that 

are also regulated as drug products) are 

subject to part 207 of this chapter. 

* * * * * 

16. Revise § 807.37 to read as follows: 

§ 807.37 Public availability of 

establishment registration and device 

listing information. 

Establishment registration and device 

listing information is available for 

public inspection in accordance with 

section 510(f) of the act and will be 

posted on the FDA Web site. Requests 

for information by persons who do not 

have access to the Internet should be 

directed to the Office of Compliance, 

Center for Devices and Radiological 

Health (HFZ–308), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Building 66, rm. 3521, Silver 

spring, MD 20993–0002. In addition, 

there will be available for inspection at 

each of the Food and Drug 

Administration district offices the same 

information for firms within the 

geographical area of such district 

offices. Upon request, verification of a 

registration number or location of a 

registered establishment will be 

provided. 

17. The heading of subpart C is 

revised to read as set forth below: 

Subpart C—Procedures for Foreign 

Device Establishments 

18. Amend § 807.40 by revising 

paragraphs (a) and (c) and by adding 

paragraph (d) to read as follows: 

§ 807.40 Establishment registration and 

device listing for foreign establishments 

importing or offering for import devices into 

the United States. 

(a) Any establishment within any 

foreign country engaged in the 

manufacture, preparation, propagation, 

compounding, or processing of a device 

that is imported or offered for import 

into the United States shall register such 

establishment and list such devices 

using the FDA electronic device 

registration and listing system in 

conformance with the procedures in this 

section, § 807.41, and subpart B of this 

part. The official correspondent for the 

foreign establishment shall facilitate 

communication between the foreign 

establishment’s management and 

representatives of the Food and Drug 

Administration for matters relating to 

the registration of device establishments 

and the listing of device products. 

* * * * * 

(c) No device may be imported or 

offered for import into the United States 

unless it is the subject of a device listing 

as required under subpart B of this part 

and is manufactured, prepared, 

propagated, compounded, or processed 

at a registered foreign establishment; 

however, this restriction does not apply 

to devices imported or offered for 

import under the investigational use 

provisions of part 812 of this chapter. 

(d) The establishment registration and 

device listing information shall be in the 

English language. 

19. Add § 807.41 to subpart C to read 

as follows: 

§ 807.41 Identification of importers and 

persons who import or offer for import. 

(a) Upon initial registration, annually, 

and at the time of any changes, each 

foreign establishment required to 

register and list as provided in 

§ 807.40(a) must, using the FDA 

electronic device registration and listing 

system, submit the name, address, 

telephone and fax numbers, e-mail 

address, and registration number, if any 

has been assigned, of any importer 

(defined in § 807.3(x)) of the 

establishment’s devices that is known to 

the foreign establishment. The foreign 

establishment must also specify which 

of the establishment’s listed products 

each importer receives from the foreign 

establishment. 

(b) Upon initial registration, annually, 

and at the time of any changes, each 

foreign establishment required to 

register and list as provided in 

§ 807.40(a) must, using the FDA 

electronic device registration and listing 

system, submit the name, address, 

telephone and fax numbers, e-mail 

address, and registration number, if any 

has been assigned, of each person who 

imports or offers for import the 

establishment’s devices into the United 

States. The term ‘‘person who imports or 

offers for import,’’ which is defined in 

§ 807.3(y), includes agents, brokers, or 

other parties used by the foreign 

establishment to facilitate the import of 

its device into the United States. 

(c) For each individual or 

organization identified by the foreign 

establishment under paragraphs (a) and 

(b) of this section, the foreign 

establishment must submit to FDA 

electronically the current FDA 

premarket submission number (e.g., 

PMA, 510(k), HDE, NDA) and any other 

identifying information that is known to 

the establishment for each device being 

imported or offered for import by the 

named individuals or organizations. 

Dated: March 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–6662 Filed 3–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–333] 

Schedules of Controlled Substances: 

Placement of Carisoprodol Into 

Schedule IV; Announcement of 

Hearing 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice of hearing on proposed 

rulemaking. 

SUMMARY: This is notice that the Drug 

Enforcement Administration (DEA) will 

hold a hearing with respect to the 

proposed placement of carisoprodol in 

schedule IV of the Controlled 

Substances Act (21 U.S.C. 801, et seq.). 

The control of carisoprodol was initially 

proposed in a Notice of Proposed 

Rulemaking published in the Federal 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 14539 

Register on November 17, 2009 [74 FR 

59108]. 

DATES: Interested persons desiring to 

participate in this hearing must provide 

written notice of desired participation 

as set out below, on or before April 26, 

2010. 

The hearing will commence on May 4, 

2010 at 10 a.m. at 600 Army Navy Drive, 

Arlington, VA 22202. 

ADDRESSES: To ensure proper handling 

of notification, please reference ‘‘Docket 

No. DEA–333’’ on all correspondence. 

Written notification sent via regular or 

express mail should be sent to Hearing 

Clerk, Office of the Administrative Law 

Judge, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152. 

FOR FURTHER INFORMATION CONTACT: 

Hearing Clerk, Office of the 

Administrative Law Judge, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone (202) 307–8188. 

SUPPLEMENTARY INFORMATION: 

Background 

On November 17, 2009, the Drug 

Enforcement Administration (DEA) 

published a Notice of Proposed 

Rulemaking (NPRM) in the Federal 

Register (74 FR 59108) to place the 

substance carisoprodol into schedule IV 

of the Controlled Substances Act (CSA) 

(21 U.S.C. 801, et seq.). The NPRM 

stated that, if this scheduling action 

were finalized, carisoprodol would be 

subject to the regulatory controls and 

criminal sanctions of schedule IV, as are 

applicable to the manufacture, 

distribution, dispensing, importation, 

and exportation of carisoprodol and 

products containing carisoprodol. 

The NPRM invited interested parties 

to submit comments, objections, and 

requests for hearing on or before 

December 17, 2009. The DEA received 

18 comments in response to the NPRM. 

Seventeen commenters strongly 

supported the control of carisoprodol. 

These commenters included health care 

providers, an organization representing 

pharmaceutical manufacturers and 

distributors, State regulatory agencies 

and State Departments of Health 

officials, law enforcement entities and 

one pain management association. 

According to these commenters, 

carisoprodol products are being 

diverted, abused, misused, and sold on 

the street and from Internet sites 

without legitimate prescriptions. 

Commenters indicated carisoprodol is 

being abused with other controlled 

drugs such as opioids. There are 

incidences of pain patients addicted to 

carisoprodol. 

While 17 comments were supportive 

of control, one commenter requested a 

hearing on the issue. This commenter 

stated that it believes ‘‘that the NPRM 

and the associated documentation do 

not provide substantial evidence to 

support the proposed scheduling of 

carisoprodol.’’ Additionally, the 

petitioner stated that ‘‘the proposal gives 

inadequate weight to the negative 

impact on patient care of scheduling 

carisoprodol.’’ In requesting a hearing, 

the commenter stated its intention to 

present factual information concerning 

the relative potential for abuse of 

carisoprodol, and expert opinion 

concerning the significance and 

reliability of data cited in the NPRM and 

associated materials. 

All comments received in response to 

the NPRM are part of the administrative 

record and will be considered by DEA 

in determining whether to finalize the 

rule placing carisoprodol into schedule 

IV. 

Hearing Notification 

In response to this request, DEA is 

convening a hearing on the NPRM. 

Accordingly, notice is hereby given that 

a hearing in connection with this 

proposed scheduling action will 

commence on May 4, 2010, at 10 a.m. 

at the Drug Enforcement 

Administration, 600 Army Navy Drive, 

Arlington, VA 22202 and will continue 

until all interested persons, as that term 

is defined in 21 CFR 1300.01(b)(19), 

desiring to participate, who have given 

notice of such desire as prescribed 

below, have been heard. The hearing 

will be conducted pursuant to the 

provisions of 5 U.S.C. 556 and 557, and 

21 CFR 1308.41–1308.45, and 1316.41– 

1316.68. 

Every interested person desiring to 

participate in the hearing shall file a 

written notice of intention to 

participate, in duplicate, with the 

Hearing Clerk, Office of the 

Administrative Law Judge, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, VA 

22152, on or before April 26, 2010. Each 

notice of intention to participate must 

be in the form prescribed in 21 CFR 

1316.48. The commenter who requested 

the hearing is hereby directed to file 

with the Administrative Law Judge a 

notice of its continued intention to 

participate in the hearing and to state 

with particularity its interest in the 

proceeding. 

Dated: March 21, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–6763 Filed 3–25–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–134235–08] 

RIN 1545–BI28 

Furnishing Identifying Number of Tax 

Return Preparer 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This document contains 

proposed regulations under section 

6109 of the Internal Revenue Code 

(Code) that provide guidance to tax 

return preparers on furnishing an 

identifying number on tax returns and 

claims for refund of tax that they 

prepare. These proposed regulations 

provide guidance on the identifying 

number of a tax return preparer for tax 

returns and claims for refund filed 

before and after the proposed effective 

date. The proposed regulations describe 

how the IRS will define the identifying 

number of tax return preparers. 

Additional provisions of the proposed 

regulations provide that tax return 

preparers must apply for and regularly 

renew their preparer identifying number 

as the IRS may prescribe in forms, 

instructions, or other guidance. This 

document also invites comments from 

the public regarding these proposed 

regulations. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by April 26, 2010. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–134235–08), Room 

5205, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may be hand-delivered Monday through 

Friday between the hours of 8 a.m. and 

4 p.m. to CC:PA:LPD:PR (REG–134235– 

08), Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC 20224, or sent 

electronically via the Federal 

eRulemaking Portal at http:// 

www.regulations.gov (IRS–REG– 

134235–08). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

Stuart Murray at (202) 622–4940 (not a 

toll-free number); concerning 

submissions of comments and requests 

for a hearing, Richard Hurst at 

richard.a.hurst@irscounsel.treas.gov. 

SUPPLEMENTARY INFORMATION: 


emcdonald on DSK2BSOYB1PROD with PROPOSALS