11028 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 

Dated: March 6, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–1144 Filed 3–9–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Immune Globulins for Primary Immune 

Deficiency Diseases: Antibody 

Specificity, Potency and Testing; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: Immune Globulins for Primary 

Immune Deficiency Diseases: Antibody 

Specificity, Potency and Testing. The 

purpose of the public workshop is to 

discuss approaches to identify the most 

relevant antibody specificities in 

Immune Globulins for the prevention of 

infections in patients with primary 

immune deficiency diseases (PIDD), and 

current and potential potency tests for 

Immune Globulins. The public 

workshop will also include a discussion 

about the declining measles antibody 

levels in U.S. licensed Immune 

Globulins and the potential clinical 

impact on patients with PIDD. The 

public workshop sponsors are FDA, the 

Immune Deficiency Foundation, and the 

Plasma Protein Therapeutics 

Association. 

Date and Time: The public workshop 

will be held on April 25, 2007, from 8 

a.m. to 5 p.m., and April 26, 2007, from 

8:30 a.m. to 11:30 a.m. 

Location: The public workshop will 

be held at the Lister Hill Center 

Auditorium, Building 38A, National 

Institutes of Health, 8800 Rockville 

Pike, Bethesda, MD 20894. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov. 

Registration: Mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

contact person by April 6, 2007. There 

is no registration fee for the public 

workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 7:30 

a.m. 

If you need special accommodations 

due to a disability, please contact 

Rhonda Dawson at least 7 days in 

advance of the workshop. 

SUPPLEMENTARY INFORMATION: The 

public workshop will feature 

presentations by national and 

international experts from government, 

academic institutions, and industry. The 

first day of the workshop will include 

discussions on: (1) Epidemiology of 

serious infections in PIDD patients; (2) 

review of European and U.S. PIDD 

registry data; (3) surveillance questions 

to address the type, rate, and severity of 

infections in PIDD patients; (4) rationale 

for current potency tests for Immune 

Globulins; (5) antibody levels in current 

Immune Globulins, including those 

levels to emerging pathogens; and (6) 

the development of additional or other 

useful potency tests. The second day of 

the workshop will focus on the potential 

clinical impact on PIDD patients of 

declining measles antibody levels in 

U.S. licensed Immune Globulins. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

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

minutes/workshop-min.htm. 

Dated: March 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4313 Filed 3–9–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Healthcare Integrity 

and Protection Data Bank for Final 

Adverse Information on Health Care 

Providers, Suppliers, and Practitioners 

(OMB No. 0915–0239)—Extension 

Section 221 (a) of the Health 

Insurance Portability and 

Accountability Act (HIPAA) of 1996 

specifically directs the Secretary to 

establish a national health care fraud 

and abuse data collection program for 

the reporting and disclosure of certain 

final adverse actions taken against 

health care providers, suppliers, and 

practitioners. A final rule was published 

October 26, 1999, in the Federal 

Register to implement the statutory 

requirements of section 1128E of the 

Social Security Act (The Act) as added 

by section 221 (a) of HIPAA. The Act 

requires the Secretary to implement the 

national health care fraud and abuse 

data collection program. This data bank 

is known as the Healthcare Integrity and 

Protection Data Bank (HIPDB). It 

contains the following types of 

information: (1) Civil judgments against 

a health care provider, supplier, or 

practitioner in Federal or State court 

related to the delivery of a health care 

item or service; (2) Federal or State 

criminal convictions against a health 

care provider, supplier, or practitioner 

related to the delivery of a health care 

item or service; (3) actions by Federal or 

State agencies responsible for the 

licensing and certification of health care 

providers, suppliers, or practitioners; (4) 

exclusion of a health care provider, 

practitioner or supplier from 

participation in Federal or State health 

care programs; and (5) any other 

adjudicated actions or decisions that the 

Secretary shall establish by regulations. 

Access to this data bank is limited to 


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