Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64313

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

grjohnson@acf.hhs.gov.

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov.

Dated: October 28, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–24600 Filed 11–3–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Provision of Services in 

Interstate Child Support Enforcement: 

Standard Forms. 

OMB No.: 0970–0085. 

Description: Pub. L. 104–193, the 

Personal Responsibility and Work 

Opportunity Reconciliation Act of 1996, 

amended 42 U.S.C. 666 to require State 

Child Support Enforcement (CSE) 

agencies to enact the Uniform Interstate 

Family Support Act (UIFSA) into State 

law by January 1, 1998. Section 311(b) 

of UIFSA requires the States to use 

standard interstate forms, as mandated 

by Federal law. 45 CFR 303.7 also 

requires CSE programs to transmit child 

support case information on standard 

interstate forms when referring cases to 

other States for processing. During the 

OMB clearance process, we are taking 

the opportunity to make revisions that 

have been requested by the States. 

Respondents: State agencies 

administering the Child Support 

Enforcement program under title IV–D 

of the Social Security Act. 

Annual Burden Estimates:

Instrument Number of

respondents 

Number of

responses per

respondent 

Average burden 

hours per

response 

Total burden

hours 

Transmittal 1 .................................................................................... 54 19,278 .25 260,253 

Transmittal 2 .................................................................................... 54 14,458 .08 62,459 

Transmittal 3 .................................................................................... 54 964 .08 4,164 

Uniform Petition ............................................................................... 54 9,639 .08 41,640 

General Testimony .......................................................................... 54 11,567 .33 206,124 

Affidavit Paternity ............................................................................. 54 4,819 .17 44,238 

Locate Data Sheet ........................................................................... 54 375 .08 1,620 

Notice of Controlling Order .............................................................. 54 964 .08 4,164 

Registration Statement .................................................................... 54 8,675 .08 37,476 

Estimated Total Annual Burden 

Hours: 662,138. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

grjohnson@acf.hhs.gov.

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address:

Katherine_T._/Astrich@omb.eop.gov.

Dated: October 27, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–24601 Filed 11–3–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000N–1409]

Medical Devices; Reclassification of 

the Iontophoresis Device

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of intent.

SUMMARY: The Food and Drug 

Administration (FDA) announces an 

opportunity to submit information and 

comments concerning FDA’s intent to 

initiate a proceeding to reclassify those 

iontophoresis devices currently in class 

III (premarket approval) into class II 

(special controls). An iontophoresis 

device is a device that is intended to use 

a direct current to introduce ions of 

soluble salts or other drugs into the 

body and induce sweating for diagnostic 

or other uses. Elsewhere in this issue of 

the Federal Register, FDA is 

withdrawing the proposed rule the 

agency issued in the Federal Register of 

August 22, 2000 (65 FR 50949) (the 

August 2000 proposed rule).

DATES: Submit written or electronic 

comments by February 2, 2005.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices 

and Radiological Health (HFZ–215), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 

23, 1983 (48 FR 53032), FDA issued a 

final rule classifying the iontophoresis 

device into class II (performance 

standards before the Safe Medical 

Devices Act of 1990 and now special 

controls) and class III (premarket 

approval), depending on its intended 

use. An iontophoresis device is a device

64314 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

that is intended to use a direct current 

to introduce ions of soluble salts or 

other drugs into the body and induce 

sweating for diagnostic or other uses. If 

the iontophoresis device is intended for 

use in the diagnosis of cystic fibrosis or 

another intended use and the labeling of 

the drug intended for use with the 

device bears adequate directions for the 

device’s use with that drug, the device 

is categorized as class II. An 

iontophoresis device that is intended to 

introduce ions of soluble salts or other 

drugs into the body for other purposes 

is categorized as class III.

In the Federal Register of August 22, 

2000, FDA proposed to amend the 

physical medicine devices regulations 

to remove the class III (premarket 

approval) iontophoresis device 

identification. FDA proposed this action 

because it believed that there were no 

preamendments iontophoresis devices 

marketed for uses other than those 

described in the class II identification. 

FDA expected that manufacturers of 

those devices currently in class III 

would be able to relabel their devices to 

meet the class II identification.

In response to the August 2000 

proposed rule, FDA received seven 

comments. Several comments disagreed 

with FDA’s assertion that no class III 

preamendments iontophoresis devices 

existed. Two comments were confused 

as to whether the requirement that a 

drug used with an iontophoresis device 

bear adequate directions for use with 

that specific device applies to the 

diagnosis of cystic fibrosis or applies 

only to other uses. Two comments 

asserted that the assumption that there 

are differences in iontophoresis devices 

that would warrant linking a particular 

device to a particular drug is in error, 

and suggested that FDA should consider 

reclassification of iontophoresis devices 

into either class I or class II as drug 

delivery systems comparable to syringes 

and pumps. In contrast, another 

comment rejected what it perceived as 

the implication that all iontophoresis 

drug delivery systems were the same 

and that any iontophoresis device could 

be relabeled to reference any drug 

approved for iontophoretic 

administration, whether or not the drug 

had actually been tested for use with 

that particular device.

FDA is issuing this document to 

provide interested persons with an 

opportunity to submit any new 

information concerning the safety and 

effectiveness of the iontophoresis 

device. After FDA reviews any 

information that the agency receives in 

response to this document, FDA will 

decide whether the agency should go 

forward with the reclassification of 

those iontophoresis devices currently in 

class III and whether a panel meeting is 

necessary before taking any action.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except individuals 

may submit one paper copy. Comments 

are to be identified with the docket 

number found in brackets in the 

heading of this document. Any received 

information may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: October 25, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–24591 Filed 11–3–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0087]

Draft Guidance for Industry on Listed 

Drugs, 30-Month Stays, and Approval 

of Abbreviated New Drug Applications 

and 505(b)(2) Applications Under 

Hatch-Waxman, as Amended by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act 

of 2003—Questions and Answers; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Listed Drugs, 30-

Month Stays, and Approval of ANDAs 

and 505(b)(2) Applications Under 

Hatch-Waxman, as Amended by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003—Questions and Answers.’’ This 

draft guidance follows the enactment of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Public Law 108–173) (MMA) on 

December 8, 2003. In part, this guidance 

satisfies FDA’s obligation under that law 

to clarify the definition of ‘‘listed drug’’

for persons who wish to submit a 

change (i.e., an amendment or 

supplement) to an abbreviated new drug 

application (ANDA). The guidance 

explains when a change to an 

application should reference a drug 

different from the drug listed in the 

original ANDA, requiring the change to 

be made through an entirely new 

application.

In addition to the definition of ‘‘listed 

drug,’’ the draft guidance clarifies 

certain other provisions of the MMA 

that significantly change the law that 

existed before the MMA’s enactment. 

These include changes regarding 30-

month stays and approval of ANDAs 

and new drug applications submitted 

under section 505(b)(2) of the Federal 

Food, Drug, and Cosmetic Act (505(b)(2) 

applications). The draft guidance also 

explains the effective dates that apply to 

the MMA’s provisions.

DATES: Submit written or electronic 

comments on the draft guidance by 

February 2, 2005. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Martin Shimer, Center for Drug 

Evaluation and Research (HFD–615), 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855 301–

827–5710.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Listed Drugs, 30-Month Stays, and 

Approval of ANDAs and 505(b)(2) 

Applications Under Hatch-Waxman, as 

Amended by the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003—Questions and Answers.’’

On December 8, 2003, the MMA was 

signed into law. Among other things, 

Title XI of that law, ‘‘Access to 

Affordable Pharmaceuticals,’’ states that 

guidance will be issued to define the 

term ‘‘listed drug’’ with respect to 

amendments and supplements to 

ANDAs. This guidance is necessary 

because the MMA specifies that, ‘‘An