Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13621 

unit cost of materials, per unit cost of 

labor, per unit cost of design, test and 

certification, etc. Data from each 

manufacturer will be held confidential 

by the CPA and coded to remove 

corporate identifiers. The goal is to 

assess the cost of change to the industry 

rather than to an individual product 

within a given manufacturers’ broad 

product line. 

Candidate companies will be 

evaluated based on their capability and 

willingness to work cooperatively to 

achieve the stated goals. Candidates 

selected will be required to enter into a 

Letter of Agreement spelling out the 

level of participation expected of each 

partner and the handling of data 

generated from the partnership. This 

announcement does not obligate NIOSH 

to enter into an agreement with any 

respondents. NIOSH reserves the right 

to establish a partnership based on the 

engineering analysis and capabilities 

found by way of this announcement or 

other searches, if determined to be in 

the best interest of the government. 

NIOSH recognizes this opportunity 

will raise many questions for 

prospective partners. In order to give all 

involved the greatest opportunity to 

understand the process and project 

expectations, the NTEA–AMD, our 

collaborative partner and host standards 

setting body, has agreed to provide a 

meeting room for us to hold an 

informational meeting to present a 

broad overview of the effort and answer 

any resulting questions. 

In order to provide us with the best 

opportunity to meet the needs of all 

prospective partners at each of these 

meetings; we request that all interested 

parties contact Jim Green, NIOSH 

Project Officer, by e-mail at 

JGreen@cdc.gov; or telephone (304) 

285–5857, by Thursday, March 17, 

2011. 

CONTACT PERSON FOR MORE INFORMATION: 

Jim Green, NIOSH Project Officer, email: JGreen@cdc.gov; telephone (304) 

285–5857. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 7, 2011. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2011–5732 Filed 3–11–11; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel; Teleconference 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Pilot for Statespecific Cross-Sectional Surveillance of 

Persons with Rare Disorders and 

Longitudinal Assessment of Outcomes, 

Funding Opportunity Announcement 

(FOA) DD11–004, and Pilot 

Longitudinal Data Collection to Inform 

Public Health—Fragile X Syndrome, 

FOA DD11–007, initial review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 11 a.m.–5 p.m., April 

21, 2011 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 

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

the Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters to Be Discussed: The meeting 

will include the initial review, 

discussion, and evaluation of ‘‘Pilot for 

State-specific Cross-Sectional 

Surveillance of Persons with Rare 

Disorders and Longitudinal Assessment 

of Outcomes, FOA DD11–004, and Pilot 

Longitudinal Data Collection to Inform 

Public Health—Fragile X Syndrome, 

FOA DD11–007.’’ 

Contact Person for More Information: 

Donald Blackman, PhD, Scientific 

Review Officer, Extramural Research 

Program Office, National Center for 

Chronic Disease Prevention and Health 

Promotion, CDC, 4770 Buford Highway, 

NE., Mailstop K–92, Atlanta, Georgia 

30341, Telephone: (770) 488–3023, Email: DBY7@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 7, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–5755 Filed 3–11–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Family History 

and Diamond Blackfan Anemia, DD11– 

010, Initial Review 

Correction: This notice was published 

in the Federal Register on January 21, 

2011, Volume 76, Number 14, Page 

3909. The date for the aforementioned 

meeting has been changed to the 

following: 

DATES: April 27, 2011 (Closed). 

Contact Person for More Information: 

Michael Dalmat, Dr.P.H., Scientific 

Review Officer, CDC, National Center 

for Chronic Disease Prevention and 

Health Promotion, Office of the Director, 

Extramural Research Program Office, 

4770 Buford Highway, NE., Mailstop K– 

92, Atlanta, Georgia 30341, Telephone: 

(770) 488–6423, E-mail: 

MED1@CDC.GOV. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 7, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–5759 Filed 3–11–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Opportunity to Partner; Testing of 

Patient Litters and Patient Restraints 

to Proposed Test Standard 

Authority: 29 U.S.C. 669. 

AGENCY: NIOSH, Centers for Disease 

Control and Prevention (CDC), 

mstockstill on DSKH9S0YB1PROD with NOTICES

13622 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of informational meeting 

and opportunity to partner. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH), CDC, HHS, in collaboration 

with the National Truck Equipment 

Association, Ambulance Manufacturers 

Division (NTEA–AMD) has developed a 

series of proposed ambulance 

component test standards. One such 

standard, AMD STANDARD 004— 

Method for Conducting Litter and Litter 

Retention System Dynamic Test— 

Proposed (draft), seeks to improve 

patient and litter retention during crash 

conditions. As a part of the standard 

development process, NIOSH will be 

conducting a series of tests to evaluate 

existing, redesigned, and/or new litters 

to validate the test methods proposed. It 

is anticipated testing will be conducted 

in up to three phases over 

approximately 15 months. NIOSH will 

contract with an independent test 

facility and provide funding for all 

testing, instrumentation, data collection, 

and data analysis. Prospective industry 

partners will provide the test assets: 

Litters and litter retention devices. This 

project has three key goals: (1) To 

validate test and data collection 

methodologies proposed in AMD 004 

(draft) to support standard development; 

(2) to support and facilitate the 

transition of the industry from the 

current litter design parameters to those 

proposed in SAE J2917 Surface Vehicle 

Recommended Practice, Occupant 

Restraint and Equipment Mounting 

Integrity—Frontal Impact System-Level 

Ambulance Patient Compartment, 

published May 2010, and SAE J2956 

Surface Vehicle Recommended Practice, 

Occupant Restraint and Equipment 

Mounting Integrity—Side Impact 

System-Level Ambulance Patient 

Compartment (draft); and, (3) to develop 

the design and production ‘‘cost-ofchange’’ to meet the proposed design 

parameters. 

DATES AND TIMES: March 23, 2011, 1 

p.m.–5 p.m., Eastern Standard Time 

(EST). March 24, 2011, 8 a.m.–12 noon, 

EST, by appointment. NIOSH is 

available to meet with individual 

companies for those interested in 

further discussion. We anticipate 

offering the prospective partners the 

opportunity to meet for 30 minutes, to 

ask specific questions pertinent to their 

situation. 

ADDRESSES: Homewood Suites 

Indianapolis-Downtown, 211 South 

Meridian Street, Indianapolis, Indiana 

46225, Telephone (317) 636–7992. 

(Coincident with the 2011 Fire 

Department Instructors Conference 

(FDIC)). 

Letters of Interest: Interested 

manufacturers should submit a letter of 

interest with information about their 

capabilities and level of proposed 

participation to Jim Green at 

JGreen@cdc.gov. Letters of interest must 

be received by April 25, 2011. 

SUPPLEMENTARY INFORMATION: NIOSH 

proposes a series of up to 48 tests to 

better understand the capabilities and 

limitations of currently available litters, 

investigate redesign or new design 

options, and validate the proposed test 

standard. As a byproduct of this effort, 

it is expected that NIOSH and its 

partners will be able to demonstrate that 

litters provided by partners meet the 

design parameters specified in AMD 004 

(draft) and test requirements outlined in 

SAE J2917 and SAE 2956 (draft), 

respectively. 

Prospective partners will be existing 

litter manufacturers nationally or 

internationally. A prospective partner 

need not be selling to the United States 

market at the time of this 

announcement. 

Prospective partners will be required 

to provide test assets (litters and 

mounting systems) free of charge in 

exchange for their participation in this 

collaborative standards development 

and validation effort. In return, NIOSH 

will cover all costs associated with 

testing. This includes the cost of the 

sled buck design and manufacture, 

rental of appropriate test manikins, 

instrumentation related to the litter, 

manikin, and sled buck, test execution, 

test data analysis, and cost data 

analysis. 

Given the nature of the proposed 

change, coupled with the cost for each 

unit, NIOSH anticipates the need to 

partner with more than one 

manufacturer. Therefore no one 

manufacturer should expect to be asked 

to contribute all needed test assets. 

In phase 1, test assets are expected to 

come from those in the existing product 

line per mutual agreement with NIOSH. 

In phases 2 and 3, test assets are 

expected to be introduced as either 

redesigns of existing products or new 

products entirely based on the results of 

phase 1 testing. The cost of product 

redesign and manufacture for phase 2 

and 3 testing would be borne by the 

manufacturer partner(s). 

Each partner will be invited to 

participate at the site of testing (a third 

party independent test facility) during 

the testing of its product. However, at 

no time will representatives from two 

different manufacturers be present at the 

same time or on the same date. As a 

participant, each partner will be 

provided with a copy of all digital video 

and instrumented data for use in future 

product development. NIOSH will 

retain a copy of all data but will code, 

to the extent possible, to prevent release 

of vendor specific product data. Partners 

will retain ownership of each test asset 

and will be asked to retrieve test assets 

once each test has been completed. All 

shipping and/or disposal costs of test 

assets to and from the independent test 

facility will be borne by the 

manufacturer partner(s). 

Recognizing any change in standard 

or test requirement may have a 

coincident cost; NIOSH will also be 

seeking to quantify the cost of change— 

that is, the cost of redesigning and 

manufacturing to meet the proposed 

new test standards. In this instance, 

NIOSH has a separate effort in place 

with an independent Certified Public 

Accountant (CPA). Any participant or 

partner in this effort would be required 

to work with the CPA in parallel with 

the test program outlined above. 

Specifically, the partner would be 

required to provide the underlying cost 

data for each product evaluated in the 

test program. This would include the 

costs for a current or comparable pretest or pre-standard litter and its 

companion post standard or post 

redesign equivalent. Prospective 

partners should be aware it may be 

possible to consider a few products 

within their existing product line (e.g.; 

entry level, mid level, and high end 

products). These costs may include: Per 

unit cost of materials, per unit cost of 

labor, per unit cost of design, test and 

certification, etc. Data from each 

manufacturer will be held confidential 

by the CPA and coded to remove 

corporate identifiers. The goal is to 

assess the cost of change to the industry 

rather than to an individual product 

within a given manufacturers’ broad 

product line. 

Candidate companies will be 

evaluated based on their capability and 

willingness to work cooperatively to 

achieve the stated goals. Candidates 

selected will be required to enter into a 

Letter of Agreement spelling out the 

level of participation expected of each 

partner and the handling of data 

generated from the partnership. This 

announcement does not obligate NIOSH 

to enter into an agreement with any 

respondents. NIOSH reserves the right 

to establish a partnership based on the 

engineering analysis and capabilities 

found by way of this announcement or 

other searches, if determined to be in 

the best interest of the government. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13623 

NIOSH recognizes this opportunity 

will raise many questions for 

prospective partners. In order to give all 

involved the greatest opportunity to 

understand the process and project 

expectations, the NTEA–AMD, our 

collaborative partner and host standards 

setting body, has agreed to provide a 

meeting room for us to hold an 

informational meeting to present a 

broad overview of the effort and answer 

any resulting questions. 

To provide us with the best 

opportunity to meet the needs of all 

prospective partners at each of these 

meetings, we request that all interested 

parties contact Jim Green, NIOSH 

Project Officer, by email at 

JGreen@cdc.gov; or telephone (304) 

285–5857, by Thursday, March 17, 

2011. 

CONTACT PERSON FOR MORE INFORMATION: 

Jim Green, NIOSH Project Officer, email: JGreen@cdc.gov; telephone (304) 

285–5857. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 7, 2011. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2011–5733 Filed 3–11–11; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0447] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Medical Devices; Third Party Review 

Program Under the Food and Drug 

Administration Modernization Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Medical Devices; Third Party Review 

Program Under the Food and Drug 

Administration Modernization Act’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 28, 2010 

(75 FR 81616), the Agency announced 

that the proposed information collection 

had been submitted to OMB for review 

and clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0375. The 

approval expires on February 28, 2014. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: March 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5738 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0116] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

medical device labeling regulations. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 13, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, PI50–400B, Food and 

Drug Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–796–5156, 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Device Labeling Regulations— 

(OMB Control Number 0910–0485)— 

(Extension) 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements for the label or 

labeling of a medical device so that it is 

not misbranded and subject to a 

mstockstill on DSKH9S0YB1PROD with NOTICES