77756 Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 69 FR 63154–63156, 

dated October 29, 2004, is amended to 

reflect the Order of Succession for the 

Centers for Disease Control and 

Prevention. 

Section C–C, Order of Succession: 

Delete in its entirety Section C–C, 

Order of Succession, and insert the 

following: 

During the absence or disability of the 

Director, Center for Disease Control and 

Prevention (CDC), or in the event of a 

vacancy in that office, the first official 

listed below who is available shall act 

as Director, except that during a 

planned period of absence, the Director 

may specify a different order of 

succession: 

1. Chief Operating Officer, CDC. 

2. Chief of Science, CDC. 

3. Chief of Public Health 

Improvement. 

4. Director, Coordinating Center for 

Infectious Diseases.*

* official organizational structure 

pending approval.

Dated: December 13, 2004. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC).

[FR Doc. 04–28377 Filed 12–27–04; 8:45 am] 

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0531]

Guidance for Industry and FDA Staff 

on Class II Special Controls Guidance 

Document: Assisted Reproduction 

Laser Systems; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Assisted Reproduction Laser 

Systems.’’ This guidance document 

describes a means by which assisted 

reproduction laser systems may comply 

with the requirement of special controls 

for class II devices. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a final rule to classify the 

assisted reproduction laser systems into 

class II (special controls). This guidance 

document is immediately in effect as the 

special control for assisted reproduction 

laser systems, but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs).

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Assisted Reproduction Laser Systems’’

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 

guidance.

Submit written comments concerning 

this 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:

Michael T. Bailey, Center for Devices 

and Radiological Health (HFZ–470), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–1180, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance describes a means by 

which assisted reproduction laser 

systems may comply with the 

requirement of special controls for class 

II devices. An assisted reproduction 

laser system images, targets, and 

controls the power and pulse duration 

of a laser beam used to ablate a small 

tangential hole in, or to thin, the zona 

pellucida of an embryo for assisted 

hatching or other assisted reproduction 

procedures. This guidance describes 

FDA’s recommendations regarding 

performance characteristics, safety 

testing, and appropriate labeling.

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

codifying the classification of assisted 

reproduction laser systems into class II 

(special controls) under section 513(f)(2) 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(2)). This 

guidance document will serve as the 

special control for assisted reproduction 

laser systems. Section 513(f)(2) of the 

act provides that any person who 

submits a premarket notification under 

section 510(k) of the act (21 U.S.C. 

360(k)) for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register

announcing such classification.

Because of the timeframes established 

by section 513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance. Therefore, FDA is 

issuing this guidance document as a 

level 1 guidance document that is 

immediately in effect. FDA will 

consider any comments that are 

received in response to this notice to 

determine whether to amend the 

guidance document.

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the agency’s current 

thinking on assisted reproduction laser 

systems. 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 ‘‘Class II Special Controls 

Guidance Document: Assisted 

Reproduction Laser Systems’’ by fax, 

call the CDRH Facts-On-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 

Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Notices 77757

document number (1539) followed by 

the pound sign (#). Follow the 

remaining voice prompts to complete 

your request.

Persons interested in obtaining a copy 

of the 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 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 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, OMB control number 

0910–0120) and the quality system 

regulation (21 CFR part 820, OMB 

control number 0910–0073). The 

labeling provisions addressed in the 

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 

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: December 16, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–28254 Filed 12–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0071]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

External Penile Rigidity Devices; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: External Penile Rigidity 

Devices.’’ This guidance document 

describes a means by which external 

penile rigidity 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 final rule to classify this 

device type into class II (special 

controls) and to exempt it from 

premarket notification requirements.

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

External Penile Rigidity 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 

guidance.

Submit written comments concerning 

this 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:

Janine Morris, Center for Devices and 

Radiological Health (HFZ–470), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2194.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 17, 

2004 (69 FR 12701), FDA announced the 

availability of a draft of this guidance 

document and invited interested 

persons to comment on it by June 15, 

2004. FDA received no comments on the 

proposed guidance and classification 

rule. The guidance document provides a 

means by which external penile rigidity 

devices may comply with the 

requirement of special controls for class 

II devices. Following the effective date 

of the final classification rule, 

manufacturers will need to address the 

issues covered in this special control 

guidance. However, the manufacturer 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness.

Also in the Federal Register of March 

17, 2004 (69 FR 12598), FDA proposed 

to classify external penile rigidity 

devices into class II with this guidance 

document as the special control. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

to classify external penile rigidity 

devices into class II (special controls) 

and exempt the devices from premarket 

notification requirements.

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on external penile 

rigidity 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 approach satisfies the 

requirements of the applicable statute 

and regulations.

III. Electronic Access

To receive ‘‘Class II Special Controls 

Guidance Document: External Penile 

Rigidity Devices’’ by fax, call the CDRH 

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the 

system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number (1231) followed by 

the pound sign (#). Follow the