Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Notices 57883 

related to future user fee legislation. 

Send suggestions or recommendations 

to the Division of Dockets Management 

(see ADDRESSES). 

FDA will place an additional copy of 

any material it receives on the docket 

for this document (2005N–0364). 

Suggestions, recommendations, and 

materials may be seen at the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday (see 

ADDRESSES). 

V. Transcripts 

Following the meeting, transcripts 

will be available for review at the 

Division of Dockets Management (see 

ADDRESSES). 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19864 Filed 9–29–05; 3:11 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0342] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

AFP-L3% Immunological Test 

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: AFP-L3% Immunological 

Test Systems.’’ This guidance document 

describes a means by which AFP-L3% 

(alpha-fetoprotein L3 subfraction 

percent) immunological test 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 AFP-L3% immunological test 

systems into class II (special controls). 

This guidance document is immediately 

in effect as the special control for AFPL3% immunological test 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: 

AFP-L3% Immunological Test 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: 

Maria Chan, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0493 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying AFP-L3% immunological 

test 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 

document announces the guidance 

document that will serve as the special 

control for AFP-L3% immunological 

test 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 (21 U.S.C. 

360c(a)(1)). 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 as a final guidance 

document. 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 AFP-L3% immunological 

test 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: AFP-L3% 

Immunological Test 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 

document number (1570) 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 

57884 Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Notices 

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: September 9, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–19853 Filed 10–3–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0347] 

Establishing a Docket for the 

Biological Products for Treatment of 

Rare Plasma Protein Disorders Public 

Workshop; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opening of a docket to receive 

information and comments on the June 

13 and 14, 2005, public workshop 

entitled ‘‘Biological Products for 

Treatment of Rare Plasma Protein 

Disorders’’ (the workshop). We are 

opening the docket to gather additional 

information from interested persons on 

the challenges in the development of 

products to treat rare plasma protein 

disorders and on current and future 

opportunities to facilitate development 

of such products. Interested persons 

may also submit comments on the 

workshop presentations and 

discussions, which we are also making 

available. 

DATES: Submit written or electronic 

comments on the workshop, related 

regulatory and scientific issues, and 

comments on information submitted to 

the docket by other interested persons 

by April 4, 2006. 

ADDRESSES: Submit written comments 

and information regarding the workshop 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852–1448. 

Submit electronic comments or 

information to http://www.fda.gov/ 

dockets/ecomments. See the 

SUPPLEMENTARY INFORMATION section for 

electronic and other access to the slide 

presentations from the workshop. 

FOR FURTHER INFORMATION CONTACT: 

Paula S. McKeever, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 6, 2005 

(70 FR 24079), we published a notice to 

announce a public workshop entitled 

‘‘Biological Products for Treatment of 

Rare Plasma Protein Disorders.’’ On 

June 13 and 14, 2005, we, in 

cosponsorship with the Office of Public 

Health and Science in the Department of 

Health and Human Services, held the 

workshop to facilitate the development 

of biological products used to treat 

patients with rare plasma protein 

disorders and to discuss related 

scientific and regulatory challenges. The 

following topics were discussed at the 

workshop: 

• Patients’ and physicians’

perspective on the need for products to 

treat rare plasma protein disorders; 

• The availability of registries and 

databases to identify patients for clinical 

trials; 

• Differences between international 

and FDA regulatory approaches to the 

licensure of products for treating rare 

plasma protein diseases; 

• Case studies describing the 

application of current FDA regulatory 

pathways to product development; 

• Issues of product reimbursement; 

and 

• Incentives for product 

development, such as the availability of 

small business and research grants, and 

orphan drug provisions. 

The meeting concluded with 

proposals for advancing product 

development, and suggestions for future 

discussions on this topic. At the end of 

the workshop, we invited written 

comments to provide an opportunity for 

additional information and discussion 

of the issues. 

We encourage interested persons to 

continue to provide information to this 

docket regarding: 

• How to facilitate development of 

products used to treat rare plasma 

protein disorders, 

• Comments on the workshop, and 

• Comments on information 

submitted to the docket by other 

interested persons. 

Information and comments submitted 

to the docket will assist us in 

determining the need for, and feasibility 

of, establishing new regulatory 

pathways and incentives for developing 

products to treat rare plasma protein 

disorders, among other issues. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the workshop and 

any additional information on the 

development of biological products for 

treatment of rare plasma protein 

disorders. 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. A copy of this notice, the 

slide presentations from the workshop, 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the slide presentations at 

http://www.fda.gov/cber/ 

summaries.htm#biother. 

Dated: September 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19852 Filed 10–3–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act