67724 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic 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. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

013. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: October 10, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22267 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0344] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Tinnitus Masker Devices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Class II Special Controls 

Guidance Document: Tinnitus Masker 

Devices.’’ The draft guidance describes 

a means by which tinnitus masker 

devices may comply with the 

requirement of special controls for class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

proposed rule to amend the 

classification regulations for the tinnitus 

masker presently classified into class II 

(special controls: labeling) to designate 

a special control for these devices. The 

draft guidance is neither final, nor is it 

in effect at this time. 

DATES: Submit written or electronic 

comments on this draft guidance by 

February 6, 2006. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Tinnitus Masker Devices’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance. 

Submit written comments concerning 

this 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Teresa Cygnarowicz, Center for Devices 

and Radiological Health (HFZ–460), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2980. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a proposed 

rule to amend the classification 

regulations for tinnitus masker devices 

presently classified into class II (special 

controls: labeling) to designate a special 

control for the devices. The draft 

guidance document describes a means 

by which the device may comply with 

the requirement of special controls for 

class II devices. Following the effective 

date of a final rule based on the 

proposed rule, any firm submitting a 

510(k) premarket notification for the 

device will need to address the issues 

covered in the special control guidance. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance or in some other way 

provides equivalent assurances of safety 

and effectiveness. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on tinnitus masker devices. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such an 

approach satisfies the requirements of 

the applicable statute and regulations. 

III. Electronic Access 

To receive ‘‘Class II Special Controls 

Guidance Document: Tinnitus Masker 

Devices’’ by fax, call the CDRH FactsOn-Demand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt, press 1 to 

order a document. Enter the document 

number (1555) followed by the pound 

sign (#). Follow the remaining voice 

prompts to complete your request. 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. CDRH maintains an 

entry on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

the draft guidance document have been 

approved by OMB in accordance with 

the PRA under the regulations 

governing premarket notification 

submissions (21 CFR part 807, subpart 

E), under OMB control number 0910–

0120. The labeling provisions addressed 

in the draft guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67725 

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. 

Dated: October 7, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22268 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0146] 

Guidance for Industry: Validation of 

Analytical Procedures for Type C 

Medicated Feeds; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final guidance for 

industry (#135) entitled ‘‘Validation of 

Analytical Procedures for Type C 

Medicated Feeds.’’ This guidance 

represents the agency’s current thinking 

on the characteristics that should be 

considered during the validation of nonmicrobiological analytical procedures 

for the analysis of drugs in Type C 

medicated feeds included as part of 

original and supplemental new animal 

drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs) for Type A 

medicated articles submitted to FDA. 

This guidance is the first in a series of 

three guidances that will discuss assay 

methods for Type C medicated feeds. 

DATES: Submit written or electronic 

comments on agency guidance 

documents at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Mary G. Leadbetter, Center for 

Veterinary Medicine (HFV–141), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 301–827–

6964, e-mail: mleadbet@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 28, 

2004 (69 FR 23209), FDA published a 

notice of availability for a draft guidance 

entitled ‘‘Validation of Analytical 

Procedures for Type C Medicated 

Feeds’’ giving interested persons until 

July 12, 2004, to comment on the draft 

guidance. FDA received no comments 

on the draft guidance and no 

substantive changes were made in 

finalizing this guidance document. 

II. Paperwork Reduction Act of 1995 

According to the Paperwork 

Reduction Act of 1995, a collection of 

information must display a valid OMB 

control number. The existing valid OMB 

control numbers for this information 

collection are 0910–0032 and 0910–

0154. This guidance contains no new 

collections of information. 

III. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on the topic. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternate method 

may be used as long as it satisfies the 

requirements of applicable statutes and 

regulations. 

IV. Comments 

As with all FDA’s guidances, the 

public is encouraged to submit written 

or electronic comments with new data 

or other new information pertinent to 

this guidance. FDA periodically will 

review the comments in the docket, and 

where appropriate, will amend the 

guidance. The agency will notify the 

public of any such amendments through 

a notice in the Federal Register. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance at any time. 

Two copies of any comments are to be 

submitted, except that individuals may 

submit one copy. Comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. A copy of the document and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Copies of the guidance document 

entitled ‘‘Validation of Analytical 

Procedures for Type C Medicated 

Feeds’’ may be obtained from the CVM 

Home Page (http://www.fda.gov/cvm) 

and from the Division of Dockets 

Management Web site (http:// 

www.fda.gov/ohrms/dockets/ 

default.htm). 

Dated: October 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22222 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Proposed Collection: Indian Health 

Service Background Investigations of 

Individuals in Positions Involving 

Regular Contact With or Control Over 

Indian Children OPM—306 Request for 

Public Comment: 30-Day Notice 

AGENCY: Indian Health Service, HHS. 

ACTION: Request for Public Comment: 

30-day Proposed Information Collection: 

Indian Health Service Background 

Investigations of Individuals in 

Positions Involving Regular Contact 

With or Control Over Indian Children 

OPM–306. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, for opportunity 

for public comment on proposed 

information collection projects, the 

Indian Health Service (IHS) has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

listed below. This proposed information 

collection project was published in the 

August 3, 2005, Federal Register (70 

51826) and allowed 60 days for public 

comment. No public comment was 

received in response to the notice. The 

purpose of this notice is to allow 30 

days for public comment to be 

submitted to OMB. 

PROPOSED COLLECTION: Title: 

0917–0028, ‘‘Indian Health Service 

Background Investigations of 

Individuals in Positions Involving 

Regular Contact With or Control Over