Federal Register / Vol. 69, No. 8 / Tuesday, January 13, 2004 / Notices 1989

that describes the type of data FDA 

recommends a manufacturer provide to 

address this issue (this section replaces 

the previous Retrieval Study section). 

When final, this draft guidance 

document will supersede ‘‘Guidance for 

Saline, Silicone Gel, and Alternative 

Breast Implants,’’ dated February 11, 

2003.

II. Significance of Guidance

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices (GGPs) regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on ‘‘Saline, Silicone 

Gel, and Alternative Breast Implants.’’ 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 approach satisfies the 

requirements of the applicable statute 

and regulations.

III. Electronic Access

To receive ‘‘Saline, Silicone Gel, and 

Alternative Breast Implants,’’ you may 

either send a fax request to 301–443–

8818 to receive a paper copy of the 

document, or send an e-mail request to 

GWA@CDRH.FDA.GOV to receive a 

paper copy or an electronic copy. Please 

use the document number (1239) to 

identify the guidance you are 

requesting.

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of the draft guidance may also do so by 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 cleared submissions, 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 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 (44 USC 3501–

3520) (the PRA). The collections of 

information addressed in Sections 3 

through 10 of the guidance document 

have been approved by OMB in 

accordance with the PRA under the 

regulations governing premarket 

approval applications (21 CFR part 814, 

OMB No. 0910–0231). The labeling 

provisions addressed in Section 11 of 

the guidance document have been 

approved under OMB No. 0910–0485.

V. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document on 

or before April 12, 2004. Submit a single 

copy of electronic comments to http://

www.fda.gov/dockets/ecomments. 

Submit two paper copies of any mailed 

comments, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Comments received may be 

seen in the Division of Dockets 

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

Monday through Friday.

Dated: January 7, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–658 Filed 1–12–04; 12:00 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY

Bureau of Citizenship and Immigration 

Services

Agency Information Collection 

Activities: Comment Request

ACTION: 60-Day Notice of Information 

Collection Under Review; National 

Interest Waivers; Supplemental 

Evidence to I–140 and I–485.

The Department of Homeland 

Security, Bureau of Citizenship and 

Immigrations Services (CIS) has 

submitted the following information 

collection request for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995. The 

proposed information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty day until March 15, 2004.

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points:

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility;

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used;

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques of 

other forms of information technology, 

e.g., permitting electronic submission of 

responses.

Overview of This Information 

Collection

(1) Type of Information Collection:

Extension of a currently approved 

collection.

(2) Title of the Form/Collection:

National Interest Waivers; Supplemental 

Evidence to I–140 and I–485.

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: No Agency 

Form Number; File No. OMB–22 Bureau 

or Citizenship and Immigration 

Services.

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individual or 

Households. The information collected 

via the submitted supplemental 

documentation will be used by the 

Bureau of Citizenship and Immigration 

Services to determine eligibility for the 

request national interest waiver and to 

finalize the request for adjustment to 

lawful permanent resident status.

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 8,000 responses at one (1) hour 

per response.

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 8,000 annual burden hours.

If you have additional comments, 

suggestions, or need a copy of the 

proposed information collection 

instrument with instructions, or a 

additional information, please contact 

Richard A. Sloan (202) 514–3291, 

Director, Regulations and Forms 

Services Division, Department of 

Homeland Security, 425 I Street, NW., 

Room 4304, Washington, DC 20536. 

Additionally, comments and/or 

1990 Federal Register / Vol. 69, No. 8 / Tuesday, January 13, 2004 / Notices 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time may also 

be directed to Mr. Richard A. Sloan.

If additional information is required 

contact: Mr. Steve Cooper, PRA 

Clearance Officer, Department of 

Homeland Security, Office of the Chief 

Information Officer, Regional Office 

Building 3, 7th and D Streets, SW., Suite 

4636–26, Washington, DC 20202.

Dated: December 12, 2003.

Richard A. Sloan,

Department Clearance Officer, Department of 

Homeland Security, Bureau of Citizenship 

and Immigration Services.

[FR Doc. 04–283 Filed 1–12–04; 8:45 am]

BILLING CODE 4410–10–M

DEPARTMENT OF HOMELAND 

SECURITY

Bureau of Citizenship and Immigration 

Services

Agency Information Collection 

Activities: Comment Request

ACTION: 60-Day Notice of Information 

Collection Under Review; Application 

for Issuance or Replacement of Northern 

Mariana Card; Form I–777.

The Department of Homeland 

Security (DHS) and the Bureau of 

Citizenship and Immigration Services 

(CIS), has submitted the following 

information collection request for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The proposed information 

collection is published to obtain 

comments from the public and affected 

agencies. Comments are encouraged and 

will be accepted for sixty days until 

March 15, 2004.

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points:

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility;

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used;

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses.

Overview of this information 

collection:

(1) Type of Information Collection:

Extension of a currently approved 

collection.

(2) Title of the Form/Collection:

Application for Issuance or 

Replacement of Northern Mariana Card.

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form I-777. 

Bureau of Citizenship and Immigration 

Services.

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. This information collection 

is used by applicants to apply for a 

Northern Mariana identification card if 

they received United States citizenship 

pursuant to Pub. L. 94–241 (Covenant to 

Establish a Commonwealth of the 

Northern Mariana Island).

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 100 responses at 30 minutes 

(.50 hours) per response.

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 50 annual burden hours.

If you have additional comments, 

suggestions, or need a copy of the 

proposed information collection 

instrument with instructions, or 

additional information, please contact 

Richard A. Sloan (202) 514–3291, 

Director, Regulations and Forms 

Services Division, Department of 

Homeland Security, Room 4034, 425 I 

Street, NW., Washington, DC 20536. 

Additionally, comments and/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time may also 

be directed to Mr. Richard A. Sloan.

If additional information is required 

contact: Mr. Steve Cooper, PRA 

Clearance Officer, Department of 

Homeland Security, Office of the Chief 

Information Officer, Regional Office 

Building 3, 7th and D Streets, SW., Suite 

4636–26, Washington, DC 20202.

Dated: December 12, 2003.

Richard A. Sloan,

Department Clearance Officer, Department of 

Homeland Security, Bureau of Citizenship 

and Immigration Services.

[FR Doc. 04–284 Filed 1–12–04; 8:45 am]

BILLING CODE 4410–10–M

DEPARTMENT OF HOMELAND 

SECURITY

Bureau of Citizenship and Immigration 

Services

Agency Information Collection 

Activities: Extension of Existing 

Collection; Comment Request

ACTION: 60-Day Notice of Information 

Collection Under Review; Generic 

Clearance of Customer Service Surveys.

The Department of Homeland 

Security, Bureau of Citizenship and 

Immigration Services (CIS), has 

submitted the following information 

collection request for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995. The 

proposed information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty days until March 15, 2004.

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points:

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility;

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used;

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses.

Overview of This Information 

Collection

(1) Type of Information Collection:

Extension of a currently approved 

collection.

(2) Title of the Form/Collection:

Generic Clearance of Customer Service 

Surveys.

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: No Agency 

Form Number; (File No. OMB–09). 

Bureau of Citizenship and Immigration 

Services.