Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 22819 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in Virology. 

Date: May 17–18, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Soheyla Saadi, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3211, 

MSC 7808, Bethesda, MD 20892, 301–435– 

0903, saadisoh@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Viruses. 

Date: May 25–26, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Soheyla Saadi, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3211, 

MSC 7808, Bethesda, MD 20892, 301–435– 

0903, saadisoh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; AARA: 

Psychosocial Risk and Disease Prevention 

Competitive Revisions. 

Date: May 25, 2010. 

Time: 2:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard Marriott Tysons Corner, 

1960–A Chain Bridge Road, McLean, VA 

22102. 

Contact Person: Martha M. Faraday, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3110, 

MSC 7808, Bethesda, MD 20892, 301–435– 

3575, faradaym@csr.nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Surgery, 

Anesthesiology and Trauma Study Section. 

Date: May 26–27, 2010. 

Time: 1 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Weihua Luo, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5114, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1170, luow@csr.nih.gov. 

Name of Committee: Endocrinology, 

Metabolism, Nutrition and Reproductive 

Sciences Integrated Review Group; 

Integrative Physiology of Obesity and 

Diabetes Study Section. 

Date: May 27–28, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Reed A Graves, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6166, 

MSC 7892, Bethesda, MD 20892, (301) 402– 

6297, gravesr@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 26, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10141 Filed 4–29–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; ARRA: 

Psychosocial Risk and Disease Prevention 

Competitive Revisions. 

Date: May 25, 2010 

Time: 2:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard Marriott Tysons Corner, 

1960–A Chain Bridge Road, McLean, VA 

22102. 

Contact Person: Martha M. Faraday, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3110, 

MSC 7808, Bethesda, MD 20892, 301–435– 

3575, faradaym@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 26, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10139 Filed 4–29–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0218] 

Considerations Regarding Food and 

Drug Administration Review and 

Regulation of Articles for the 

Treatment of Rare Diseases; Public 

Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing regarding the Agency’s 

regulation of drugs, biological products, 

and devices (e.g., therapies and 

diagnostics) for the treatment, diagnosis, 

and/or management of rare diseases. 

This public hearing is intended to gain 

from health care providers, academia, 

industry, patients, and other interested 

persons their perspectives on various 

aspects of the development of medical 

products for the diagnosis, treatment, or 

management of rare diseases. The input 

from this public hearing will help 

inform the work of FDA’s committee for 

rare diseases. To help solicit such 

information and views, FDA is seeking 

responses to specific questions. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
22820 Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 

DATES: The public hearing will be held 

on June 29 and 30, 2010, from 9 a.m. to 

5 p.m. However, depending on the level 

of public participation, the meeting may 

be extended or may end early. Submit 

written or electronic requests for oral 

presentations to Paras M. Patel (see FOR

FURTHER INFORMATION CONTACT) by May 

31, 2010. Submit written comments to 

the Division of Dockets Management by 

May 31, 2010. Submit electronic 

comments to http://www.regulations.gov 

by May 31, 2010. Written or electronic 

comments will be accepted after the 

hearing until August 31, 2010. 

ADDRESSES: The public hearing will be 

held at 10903 New Hampshire Ave., 

Bldg. 31, rm. 1503, Silver Spring, MD 

20993. Additional information on 

parking and public transportation may 

be accessed at http://www.fda.gov/ 

AboutFDA/WorkingatFDA/Buildingsand

Facilities/WhiteOakCampus

Information/ucm058421.htm. (FDA has 

verified the Web site addresses 

throughout this document, but FDA is 

not responsible for any subsequent 

changes to the Web sites after this 

document publishes in the Federal 

Register.) 

Submit written comments 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.regulations.gov. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management at http:// 

www.regulations.gov approximately 45 

days after the hearing. 

FOR FURTHER INFORMATION CONTACT: 

Paras M. Patel, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5271, Silver Spring, 

MD 20993–0002, 301–796–8660, FAX: 

301–847–8621, e-mail: 

OPDAR@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The development of therapies and 

diagnostics for people with rare 

diseases, defined as those conditions 

which affect fewer than 200,000 people 

in the United States, presents economic 

and scientific challenges. Prior to the 

1983 passage of (and subsequent 

amendments to) the Orphan Drug Act 

(ODA), the high development cost for 

therapies targeting few patients was 

often a prohibitive economic barrier; 

from 1973–1982 only 12 new drugs for 

rare diseases were approved by FDA. 

Since the ODA’s passage, 357 drugs and 

biological products with Orphan 

Designation have received FDA 

marketing approval. More modest 

advances have been made in medical 

devices for people with rare diseases 

through the humanitarian use device 

(HUD) and humanitarian device 

exemption (HDE) programs. 

Nevertheless for most of the estimated 

7,000 rare diseases that affect an 

estimated 30 million Americans, no 

approved therapies exist. 

To optimize the means by which FDA 

considers articles for people with rare 

diseases, a recent public law 

(Agriculture, Rural Development, Food 

and Drug Administration, and Related 

Agencies Appropriations Act, 2010, 

Public Law 111–80, section 740) calls 

for the establishment of a committee of 

FDA employees to consider the means 

by which the Agency reviews the data 

from non-clinical studies and clinical 

trials, and makes decisions about 

marketing authorization and 

postmarketing surveillance for these 

patient populations. This committee, 

which was established March 11, 2010, 

is seeking public input to benefit from 

a better understanding of the opinions 

and suggestions of external 

stakeholders. 

II. Purpose and Scope of the Hearing 

This hearing is intended to provide 

advocates for patients with rare 

diseases, academics, health care 

providers, the pharmaceutical industry, 

and other interested parties an 

opportunity to relate their experience 

with, concerns about, and suggestions 

for the way FDA regulates the scientific 

evaluation of, marketing authorization 

for, and postmarket surveillance of, 

articles for rare diseases. The scope of 

such presentations may include nonclinical testing, clinical trials, and 

decisions regarding marketing 

authorization and postmarketing 

surveillance of products for the 

diagnosis or treatment of rare diseases. 

FDA invites public comment from 

interested parties on the following 

questions/issues: 

1. Orphan drug marketing 

applications are reviewed under the 

same review process and statutory 

standards regarding demonstration of 

safety, effectiveness, and product 

quality as drugs for patients with nonorphan diseases or conditions. FDA is 

sensitive to the unique needs of patients 

with rare diseases as it makes approval 

decisions regarding the overall riskbenefit profile of therapies for the 

particular patient population for which 

they are being considered. Please 

comment on whether this practice has 

adequately addressed the needs of 

patients with rare diseases. If 

improvements are suggested, please 

provide specific examples/suggestions 

for any recommended changes. 

2. FDA designates a medical device as 

an HUD designed to treat or diagnose a 

rare disease—defined in this instance as 

a disease affecting or manifesting in 

fewer than 4,000 patients per year. 

Please comment on whether this 

practice has adequately addressed the 

needs of patients with rare diseases. 

Please also comment and provide your 

rationale on whether 4,000 patients 

constitutes an appropriate population 

size for an HUD determination. If 

improvements are suggested, please 

provide specific examples/suggestions 

for any recommended changes. 

3. Current regulations for the approval 

of an HUD through the HDE pathway 

require that the application have a 

‘‘description of the device and a 

discussion of the scientific rationale for 

the use of the device for the rare disease 

or condition’’ and ‘‘an explanation of 

why the probable benefit to health from 

the use of the device outweighs the risk 

of injury or illness from its use, taking 

into account the probable risks and 

benefits of currently available devices or 

alternative forms of treatment’’ (21 CFR 

814.102 and 814.104). Please comment 

if you believe that these standards 

remain appropriate for the approval of 

devices for rare diseases under the HDE 

mechanism; please also comment 

whether a more precise definition of 

probable benefit is needed. 

4. Have current processes for rare 

disease stakeholders to communicate 

with FDA regarding rare disease article 

development been useful? How could 

these processes be improved? Please 

provide specific examples/suggestions 

for any recommended changes. 

III. Attendance and/or Participation in 

the Public Hearing 

The public hearing is free and seating 

will be on a first-come, first-served 

basis. Attendees who do not wish to 

make an oral presentation do not need 

to register. 

If you wish to make an oral 

presentation during the hearing, you 

must register by submitting a written or 

electronic request by close of business 

on May 31, 2010, to Paras M. Patel (see 

FOR FURTHER INFORMATION CONTACT). You 

must provide your name, title, business 

affiliation (if applicable), address, 

telephone and fax numbers, e-mail 

address, and type of organization you 

represent (e.g., industry, consumer 

organization). You also should submit a 

brief summary of the presentation, 

including the discussion topic(s) that 

will be addressed and the approximate 

time requested for your presentation. 

We encourage individuals and 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 22821 

organizations with common interests to 

consolidate or coordinate their 

presentations to allow adequate time for 

each request for presentation. Persons 

registered to make an oral presentation 

should check in before the hearing. 

Participants should submit a copy of 

each presentation to Paras M. Patel. We 

will file the hearing schedule, indicating 

the order of presentation and the time 

allotted to each person, with the 

Division of Dockets Management (see 

ADDRESSES). We will mail, e-mail, or fax 

the schedule to each participant before 

the hearing. Participants are encouraged 

to arrive early to ensure the designated 

order of presentation. 

If you need special accommodations 

due to a disability, please contact Paras 

M. Patel at least 14 days in advance. 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The hearing will be 

conducted by a presiding officer, 

accompanied by FDA senior 

management from the Office of the 

Commissioner, the Office of Orphan 

Products Development, as well as 

representatives from the committee 

established by section 740 of the 

Agriculture, Rural Development, Food 

and Drug Administration, and Related 

Agencies Appropriations Act, 2010. 

Under paragraph § 15.30(f), the 

hearing is informal, and the rules of 

evidence do not apply. No participant 

may interrupt the presentation of 

another participant. Only the presiding 

officer and panel members may question 

any person during or at the conclusion 

of each presentation (§ 15.30(e)). 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR 10.203(a)). Under 21 CFR 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. 

The hearing will be transcribed as 

stipulated in paragraph § 15.30(b). 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 45 days after the hearing. 

A transcript will also be available in 

either hardcopy or on a CD–ROM after 

submission of a Freedom of Information 

request. Submit written requests to the 

Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

To the extent that the conditions for 

the hearing, as described in this 

document, conflict with any provisions 

set out in part 15, this notice acts as a 

waiver of those provisions as specified 

in § 15.30(h). 

V. Request for Comments 

Interested persons may submit written 

or electronic comments for 

consideration to the Division of Dockets 

Management (see ADDRESSES). Persons 

who wish to provide additional 

materials for consideration should file 

these materials with the Division of 

Dockets Management. You should 

annotate and organize your comments to 

identify the specific questions identified 

by topic to which they refer. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments 

should 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: April 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10079 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

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 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 75 

FR 14608, dated March 26, 2010) is 

amended to reflect the reorganization of 

the Center for Global Health, Centers for 

Disease Control and Prevention. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: Delete in their entirety the titles 

and functional statements for the Center 

for Global Health (CW), and insert the 

following: 

Center for Global Health (CW). The 

Center for Global Health (CGH): (1) 

Leads the execution of the Center for 

Disease Control and Prevention’s (CDC) 

global health strategy; (2) works in 

partnership to assist Ministries of 

Health to plan, manage effectively, and 

evaluate health programs; (3) achieves 

U.S. Government program and 

international organization goals to 

improve health, including disease 

eradication and elimination targets; (4) 

expands CDC’s global health programs 

that focus on the leading causes of 

mortality, morbidity and disability, 

especially chronic disease and injuries; 

(5) generates and applies new 

knowledge to achieve health goals; and 

(6) strengthens health systems and their 

impact. 

Office of the Director (CWA). (1) 

Provides strategic direction and 

guidance on the execution of CDC’s 

global health strategy including 

decision-making, policy development 

and program planning and evaluation; 

(2) ensures the impact and effectiveness 

of Congressionally-mandated programs; 

(3) improves implementation and 

coordination of CDC global programs; 

(4) harmonizes CDC global health 

priorities with host country priorities to 

improve essential public health 

functions and maximize positive health 

outcomes, country ownership and 

sustainability; (5) supervises all CDC 

country directors and provides 

leadership in the selection of additional 

countries to expand or establish 

collaboration; (6) measures the 

performance of CDC’s global health 

programs in terms of public health 

impact and fiscal accountability; (7) 

facilitates the conduct and maintenance 

of ethical and high quality, evidencebased scientific investigations by 

implementing regulatory requirements, 

monitoring human subjects compliance, 

and clearing scientific products; (8) 

promotes cross-cutting agendas and 

harmonizes CDC’s global laboratory 

science activities to improve diagnostic 

methodologies and respond to threats of 

emerging pathogens; (9) provides 

leadership to promote growth of CDC 

global health programs; (10) analyzes, 

measures, and evaluates the global 

burden and distribution of disease; (11) 

promotes scientific innovation and best 

technical practices in global health 

surveillance, epidemiology, outbreak 

investigation, monitoring and 

evaluation, and informatics; (12) 

provides leadership on issues 

management, budget formulation and 

performance integration, and countryspecific issues through triaging to 

programs; (13) participates in defining, 

developing, shaping and implementing 

U.S. global health policy and actions; 

(14) manages inter-governmental and 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1