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