Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 46607 

not being pursued for this technology): 

‘‘Deletion of Lysogeny Genes and Toxin 

Genes from Bacteriophage Used in the 

Epidemiologic Control of Bacterial 

Illness.’’ 

HHS Reference No. E–179–1996— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Therapeutics Use of Phage Expressing 

Toxin-Binding and/or Cytokine-Binding 

Proteins and Elimination of Genes 

Associate with Lysogeny.’’ 

HHS Reference No. E–196–1997— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Antibacterial Therapy with 

Bacteriophage Genotypically Modified 

to Delay Inactivation by the Host 

Defense System.’’ 

HHS Reference Nos. E–089–1998 and 

E–257–2003—Research Materials (patent 

protection is not being pursued for this 

technology): ‘‘Two Enterocin-Producing 

Strains of Bacteria and Their Enterocins, 

Both of Which Are Lethal to 

Vancomycin-Resistant Enterococcus 

faecium.’’ 

HHS Reference No. E–012–1999— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Long Circulating Phage Vectors.’’ 

Licensing Status: Technologies are 

available for licensing, either 

individually or as a package. 

Licensing Contact: Bruce Goldstein, 

J.D., M.S.; 301–435–5470; 

goldsteb@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI Laboratory of Molecular 

Biology is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact John D. Hewes, PhD at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Dated: September 1, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–21787 Filed 9–9–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0392] 

Medical Devices: Neurological 

Devices; Electroconvulsive Therapy 

Device; Establishing a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opening of a public docket to receive 

information and comments regarding 

the current classification process related 

to electroconvulsive therapy devices 

(ECT). The current classification process 

for this device pertains to the ‘‘Order for 

Certain Class III Devices; Submission of 

Safety and Effectiveness,’’ published in 

the Federal Register of April 9, 2009 (74 

FR 16214). Under the Order, FDA 

required manufacturers of certain Class 

III devices, including ECT, to submit a 

summary of, and citation to, any 

information known or otherwise 

available to them respecting such 

devices, including adverse safety or 

effectiveness information which has not 

been submitted under the Federal Food, 

Drug, and Cosmetic Act (the act). For 

each device subject to the Order, FDA 

is reviewing the submitted information 

to determine whether FDA should 

maintain the device as class III and 

require the submission of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP), or whether FDA should 

reclassify the device into class II or class 

I. FDA is now inviting interested 

persons to submit comments that relate 

to the safety and effectiveness of ECT. 

DATES: Submit written or electronic 

comments and information by January 

8, 2010. 

ADDRESSES: Submit written comments 

and information to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments and 

information to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Victor Krauthamer, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., W066–1106, Silver Spring, MD 

20993, 301–796–2474. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 9, 

2009 (74 FR 16214), FDA published an 

‘‘Order for Certain Class III Devices; 

Submission of Safety and Effectiveness 

Information’’ (‘‘515(i) Order’’). Under 

this Order, as mandated by section 

515(i) of the act (21 U.S.C. 360e(i)), FDA 

required manufacturers of certain class 

III devices that were in commercial 

distribution before May 28, 1976, and 

devices found to be substantially 

equivalent to them that were marketed 

on or after that date, including ECT, to 

submit to FDA by August 7, 2009, a 

summary of, and citation to, any 

information known, or otherwise 

available to them respecting those 

devices including, adverse safety or 

effectiveness data that had not been 

submitted under section 519 of the act 

(21 U.S.C. 360i). In addition, 

manufacturers were encouraged by FDA 

to submit a summary of the information 

previously sent to FDA under section 

519 of the act. Currently, the agency is 

in the process of reviewing the 

information that has been submitted by 

the manufacturers subject to the 515(i) 

Order. 

Based upon the review of this 

submitted information, FDA is 

considering whether to issue a proposed 

rule requiring the device to remain in 

class III, followed by the issuance of a 

regulation requiring submission of a 

PMA or PDP, or to revise the 

classification of the devices into class II, 

requiring the designation of special 

controls, or into class I, requiring only 

general controls. In determining 

whether to revise the classification of a 

device, or to require a device to remain 

in class III, FDA will apply the criteria 

set forth in section 513(a) of the act. If 

FDA decides to reclassify the device, 

FDA must determine that general 

controls alone (class I) or general 

controls plus special controls (class II) 

would provide reasonable assurance of 

the safety and effectiveness of the 

device. FDA’s proposed classification of 

ECT devices will be subject to notice 

and comment rulemaking to allow for 

additional public comment. 

FDA has received a significant 

number of inquiries from members of 

the public and the health care 

community in response to this order to 

ECT manufacturers. In recognition of 

this significant public interest, FDA is 

opening this docket to permit 

individuals other than manufacturers to 

submit information related to the safety 

and effectiveness of ECT. If individuals 

wish to report an adverse event 

associated with the use of an ECT 

device, please use the MedWatch 

Online Voluntary Reporting Form 

available at https:// 

www.accessdata.fda.gov/scripts/ 

medwatch/medwatch-online.htm. FDA 

will review information submitted 

through the MedWatch program prior to 

making any changes to the classification 

of ECT devices. 

II. 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 


erowe on DSK5CLS3C1PROD with NOTICES
46608 Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 

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: August 24, 2009. 

Catherine M. Cook, 

Associate Director for Regulations and Policy. 

[FR Doc. E9–21807 Filed 9–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; GO Grants-2. 

Date: September 15, 2009. 

Time: 2 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Bethesda, 

MD 20892 (Telephone Conference Call). 

Contact Person: Marita R. Hopmann, PhD, 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, 6100 Building, Room 

5B01, Bethesda, MD 20892, (301) 435–6911, 

hopmannm@mail.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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–21771 Filed 9–9–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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: National Institute of 

Child Health and Human Development Initial 

Review Group; Developmental Biology 

Subcommittee. 

Date: October 5–6, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Washington, 1515 

Rhode Island Ave, NW., Washington, DC 

20005. 

Contact Person: Norman Chang, PhD, 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health And 

Human Development, NIH, 6100 Executive 

Blvd., Room 5b01, Bethesda, MD 20892, 

(301) 496–1485, changn@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–21776 Filed 9–9–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; 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: National Human 

Genome Research Institute Initial Review 

Group; Genome Research Review Committee. 

Date: November 5–6, 2009. 

Time: 8:30 a.m. to 5 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: Ken D. Nakamura, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Human Genome Research 

Institute, National Institutes of Health, 

Bethesda, MD 20892, 301 402–0838. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: September 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–21773 Filed 9–9–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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, 


erowe on DSK5CLS3C1PROD with NOTICES