12744 Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Notices 

supporting, or life sustaining, if FDA 

finds that such a device should be 

subject to part 803 in order to protect 

the public health (section 

519(a)(1)(B)(i)(III) of the FD&C Act). If 

such class I or class II devices are not 

the subject of an FDA notice or letter, 

the malfunction reports for these 

devices are to be submitted in 

accordance with the criteria established 

by the Secretary (and, by delegation, 

FDA), which criteria shall require the 

reports to be in summary form and 

made on a quarterly basis (section 

519(a)(1)(B)(ii) of the FD&C Act). 

Under section 519(a) of the FD&C Act, 

as amended by FDAAA, there is no 

change to the obligation for an importer 

to submit malfunction reports to the 

manufacturer in accordance with part 

803 for devices that it imports into the 

United States (section 519(a)(1)(B)(iii) of 

the FD&C Act). 

FDA intends to provide notice in the 

Federal Register that lists the types of 

devices that should be subject to part 

803 in order to protect the public health, 

as required by section 519(a)(1)(B)(i)(III) 

of the FD&C Act). In addition, FDA 

intends to, by rulemaking, establish 

malfunction reporting criteria for 

devices subject to section 519(a)(1)(B)(ii) 

of the FD&C Act. In the interim, in the 

interest of public health, FDA is 

publishing this notice under section 

519(a)(1)(B)(i)(III), to clarify that, to the 

extent there is any confusion as to 

current malfunction reporting 

requirements, all device manufacturers 

and importers of class I and those class 

II devices that are not permanently 

implantable, life supporting, or life 

sustaining, must continue to report in 

full compliance with part 803, pending 

further FDA notice under section 

519(a)(1)(B)(i)(III), as to specific devices 

or device types subject to part 803, and 

the establishment of criteria in 

accordance with section 519(a)(1)(B)(ii). 

FDA considers it necessary to subject all 

such devices to part 803 in the interim, 

in order to protect the public health by 

ensuring that there is no gap in 

malfunction reporting for any device. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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: March 2, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5146 Filed 3–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute On Deafness and 

Other Communication Disorders; 

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: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Clinical 

Trials—Communications. 

Date: March 31, 2011. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852. 

(Telephone Conference Call.) 

Contact Person: Christine A. Livingston, 

PhD, Scientific Review Officer, Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892, (301) 496–8683, 

livingsc@mail.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; P50 Grant 

Review. 

Date: April 8, 2011. 

Time: 11 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852. 

(Telephone Conference Call.) 

Contact Person: Christine A. Livingston, 

PhD, Scientific Review Officer, Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892, (301) 496–8683, 

livingsc@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: March 2, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–5228 Filed 3–7–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; 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 Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel, NCCAM Education 

Panel. 

Date: March 24–25, 2011. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Peter Kozel, PhD., 

Scientific Review Officer, NCCAM, 6707 

Democracy Boulevard, Suite 401, Bethesda, 

MD 20892–5475, 301–496–8004, 

kozelp@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: March 2, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–5226 Filed 3–7–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Notices 12745 

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: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Inflammation and Cardiovascular Disease. 

Date: March 24, 2011. 

Time: 9 a.m. to 1:30 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: Giuseppe Pintucci, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7192, 

Bethesda, MD 20892, 301–435–0287, 

Pintuccig@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Hematopoietic Transplantation Data 

Coordinating Center (DCC). 

Date: March 29, 2011. 

Time: 8 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard Crystal City, 2899 

Jefferson Davis Highway, Arlington, VA 

22204. 

Contact Person: Keith A. Mintzer, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7186, 

Bethesda, MD 20892–7924, 301–435–0280, 

mintzerk@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI—Sickle Cell Disease. 

Date: March 30, 2011. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Giuseppe Pintucci, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7192, 

Bethesda, MD 20892, 301–435–0287, 

Pintuccig@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Severe Asthma Research Program. 

Date: March 31, 2011. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Georgetown, 2101 

Wisconsin Avenue, NW., Washington, DC 

20007. 

Contact Person: Keith A. Mintzer, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7186, 

Bethesda, MD 20892–7924, 301–435–0280, 

mintzerk@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: March 2, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–5225 Filed 3–7–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Special Emphasis 

Panel. 

Date: March 31, 2011. 

Time: 10 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817. 

(Telephone Conference Call.) 

Contact Person: Betty Poon, PhD, Scientific 

Review Officer, Scientific Review Program, 

Division of Extramural Activities, NIAID/ 

NIH/DHHS, 6700B Rockledge Drive, MSC 

7616, Bethesda, MD 20892–7616, 301–402– 

6891, poonb@mail.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Infectious Disease 

Conference Grants. 

Date: April 18–22, 2011. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817. 

(Virtual Meeting.) 

Contact Person: Dharmendar Rathore, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892, 301–435–2766, 

rathored@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 2, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–5229 Filed 3–7–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2010–0055] 

Privacy Act of 1974; Department of 

Homeland Security Office of 

Operations Coordination and 

Planning—002 National Operations 

Center Tracker and Senior Watch 

Officer Logs System of Records 

AGENCY: Privacy Office, DHS. 

ACTION: Notice of Privacy Act system of 

records. 

SUMMARY: In accordance with the 

Privacy Act of 1974, the Department of 

Homeland Security proposes to 

establish a new Department of 

Homeland Security system of records 

notice titled, ‘‘Department of Homeland 

Security Office of Operations 

Coordination and Planning—002 

National Operations Center Tracker and 

Senior Watch Officer Logs System of 

Records.’’ This system of records 

consists of a National Operations Center 

and Senior Watch Officer Tracker Logs. 

The Senior Watch Officer Tracker Log is 

a synopsis, in the form of a word 

document, that records all significant 

information received and actions taken 

by the Senior Watch Officer during the 

shift. The National Operations Center 

Tracker Log is the underlying 

cumulative repository of responses to 

all-threats and all-hazards, man-made 

disasters and acts of terrorism, and 

natural disasters, and requests for 

information that require a National 

Operations Center tracking number. The 

National Operations Center tracker 

numbers are used in a wide variety of 

products originated by the Department 

or external sources. They are shared 


srobinson on DSKHWCL6B1PROD with NOTICES