50214 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 

2011. A copy of the Committee charter 

can be obtained by contacting the 

Committee’s Executive Secretary. A 

copy of the Committee charter also can 

be obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The Web site address 

for the FACA database is http://fido.gov/ 

facadatabase. 

Dated: September 23, 2009. 

Penelope Slade-Sawyer, 

RADM, USPHS, Deputy Assistant Secretary 

for Health (Disease Prevention and Health 

Promotion), Office of Disease Prevention and 

Health Promotion. 

[FR Doc. E9–23539 Filed 9–29–09; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0434] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Humanitarian Device Exemption 

Holders, Institutional Review Boards, 

Clinical Investigators, and Food and 

Drug Administration Staff: 

Humanitarian Device Exemption 

Regulation: Questions and Answers; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 30, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title Guidance for Humanitarian Device 

Exemption Holders, Institutional 

Review Boards, Clinical Investigators, 

and FDA Staff: Humanitarian Device 

Exemption Regulation: Questions and 

Answers; Availability. Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Humanitarian Device 

Exemption Holders, Institutional 

Review Boards, Clinical Investigators, 

and FDA Staff: Humanitarian Device 

Exemption Regulation: Questions and 

Answers—(OMB Control Number 0910– 

NEW) 

Title III of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law 110–85) 

amended chapter V of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 351 et seq.) by inserting section 

515A, Pediatric Uses of Devices (21 

U.S.C. 360e–1). 

This new provision requires that new 

applications under section 520(m) of the 

act (21 U.S.C. 360j(m)) include both a 

description of any pediatric 

subpopulation that suffer from: (1) A 

disease or condition that the device is 

intended to treat, diagnose, or cure and 

(2) the number of affected pediatric 

patients. 

Title III of FDAAA also amended 

section 520(m) of the act as follows: 

Section 520(m)(6)(A)(ii) of the act 

provides that the Secretary of Health 

and Human Services will assign an 

annual distribution number (ADN) for 

devices indicated for use in a pediatric 

population or in a pediatric 

subpopulation. The ADN shall be based 

on the following information in a 

humanitarian device exemption (HDE) 

application: (1) The number of 

individuals affected by the disease or 

condition that such device is intended 

to treat, diagnose, or cure and of that 

number; (2) the number of individuals 

likely to use the device and (3) the 

number of devices reasonably necessary 

to to treat such individuals. 

Section 520(m)(6)(A)(iii) of the act 

provides that an HDE holder 

immediately notify the agency if the 

number of devices distributed during 

any calendar year exceeds the ADN. 

Section 520(m)(6)(C) of the act 

provides that an HDE holder may 

petition to modify the ADN if additional 

information on the number of 

individuals affected by the disease or 

condition arises. 

In the Federal Register of August 5, 

2008 (73 FR 45460), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. Seven comments were 

received in response to the 60-day 

notice. Of the seven comments received, 

six related to the guidance and the 

information collection requests. We 

received one comment that did not 

address the content of the guidance nor 

the information collection. 

There were a number of comments 

received that clarified the reporting 

requirements for HDE holders and 

institutional review boards (IRBs). In 

response to these comments, FDA 

responded by referring to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

803.50 have been approved under OMB 

control number 0910–0437 and the 

collections of information in part 814 

(21 CFR part 814) have been approved 

under OMB control number 0910–0332. 

FDA received comments that sought 

clarification regarding how an IRB 

distinguishes between the use of a 

humanitarian use device (HUD) and the 

study of an HUD in a clinical 

investigation. FDA responded by 

providing additional background 

information related to the collection of 

safety and effectiveness information 

related to clinical investigation for HDE 

approved indications and referring to 

previously approved collections of 

information found in FDA regulations. 

This collection of information is 

approved under OMB control number 

0910–0078. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Federal Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

515A(a)(2) 5 1 5 100 500 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 50215 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Section of the Federal Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

520(m)(6)(A)(ii) 3 1 3 50 150 

520(m)(6)(A)(iii) 1 1 1 100 100 

520(m)(6)(C) 5 1 5 100 500 

Total 1,250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA based these estimates on the 

number of original HDE applications 

that the Center for Devices and 

Radiological Health (CDRH) received in 

the period between October 1, 2004, and 

September 30, 2007. During that time, 

CDRH received 16 original HDE 

applications or about 5 per year. 

FDA estimates that for each year, 

CDRH will receive five HDE 

applications and that three of these 

applications will be indicated for 

pediatric use. One HDE holder will 

notify the agency that the number of 

devices distributed in the year has 

exceeded the ADN and five HDE holders 

will petition to have the ADN modified 

due to additional information on the 

number of individuals affected by the 

disease of condition. 

The draft guidance refers also to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in part 

814, subparts A, B, and C have been 

approved under OMB control number 

0910–0231; the collection of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in part 814, subpart H have 

been approved under OMB control 

number 0910–0332; and the collection 

of information requirements in 21 CFR 

10.30 have been approved under OMB 

control number 0910–0183. 

Dated: September 23, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23521 Filed 9–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Immortalized Transformed 

Lymphoblastoid Cell Lines From 

Patients with Franc ̧ois-Neetens 

Mouchete ́e Fleck Corneal Dystrophy 

(CFD) 

Description of Invention: Researchers 

at the National Eye Institute, NIH, have 

made available a set of immortalized 

transformed lymphoblastoid cell lines 

created from human T-lymphocytes 

obtained from patients with Franc ̧oisNeetens Mouchete ́e Fleck Corneal 

Dystrophy (CFD). The cells were 

transformed with defective Epstein-Barr 

virus using established methods. 

CFD is a rare, autosomal dominant 

corneal dystrophy characterized by 

numerous small white flecks scattered 

in all layers of the stroma. CFD has been 

associated with mutations in the PIP5K3 

protein, which is important for postGolgi vesicle processing. 

Applications: 

• Useful in the study of proteins 

expressed by lymphocytes, including in 

some cases the protein encoded by the 

mutant gene KCNJ13. 

• Useful as a renewable source of 

DNA for genetic studies related to CFD 

or the PIP5K3 protein. 

Inventors: J. Fielding Hejtmancik and 

Xiaodong Jiao (NEI). 

Relevant Publications: 

1. S Li et al. Mutations in PIP5K3 are 

associated with Franc ̧ois-Neetens 

mouchete ́e fleck corneal dystrophy. Am 

J Hum Genet. 2005 Jul;77(1):54–63. 

2. X Jiao et al. Genetic linkage of 

Francois-Neetens fleck (mouchete ́e) 

corneal dystrophy to chromosome 2q35. 

Hum Genet. 2003 May; 112(5–6):593– 

599. 

Patent Status: HHS Reference No. E– 

270–2009/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a biological material 

license. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Novel Chemoattractant-Based Toxins to 

Improve Vaccine Immune Responses 

for Cancer and Infectious Diseases 

Description of Invention: Cancer is 

one of the leading causes of death in 

United States and it is estimated that 

there will be more than half a million 

deaths caused by cancer in 2009. A 

major drawback of the current 

chemotherapy-based therapeutics is the 

cytotoxic side-effects associated with 

them. Thus there is a dire need to 

develop new therapeutic strategies with 

fewer side-effects. Immunotherapy has 

taken a lead among the new therapeutic 

approaches. Enhancing the innate 

immune response of an individual has 

been a key approach for the treatment 

against different diseases such as cancer 

and infectious diseases. 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES