Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10371 

CWHSP will soon be accepting digital 

images as well as the traditional analog 

x-ray films, the number of x-ray 

facilities participating will increase over 

the next several years. This increase is 

reflected in this submission. The forms 

associated with this approval process 

require approximately 30 minutes for 

completion. 

ESTIMATED ANNUALIZED BURDEN

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden/ 

response 

(in hrs) 

Total burden 

(in hrs) 

Invoice-Pathologist ........................................................................................... 50 1 5/60 4 

Report-Pathologist ........................................................................................... 50 1 5/60 4 

Consent, Release and History Form—Next-of-Kin ..........................................

(Form 2.6) ........................................................................................................ 50 1 15/60 13

Roentgenographic Interpretation Form—Physicians (Form 2.8) ..................... 10,000 1 3/60 500 

Interpreting Physician Certification Document—Physicians ............................

(Form 2.12) ...................................................................................................... 300 1 10/60 50

Miner Identification Document—Coal Miners ..................................................

(Form 2.9) ........................................................................................................ 5,000 1 20/60 1,666 

Spirometry Test—Coal Miners ......................................................................... 2,500 1 20/60 833 

X-ray—Coal Miners ......................................................................................... 5000 1 15/60 750 

Coal Mine Operators Plan—Mine Operators ...................................................

(Form 2.10) ...................................................................................................... 200 1 30/60 100 

Facility Certification Document—X-ray Facilities .............................................

(Form 2.11) ...................................................................................................... 100 1 30/60 200 

Total .......................................................................................................... ........................ ........................ ........................ 4,120 

Dated: February 16, 2011. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–4165 Filed 2–23–11; 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: Occupational 

Safety and Health Training Project 

Grant, Program Announcement PAR 10– 

288, 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: 

Times and Dates: 8:30 a.m.–5 p.m., March 

17, 2011 (Closed). 

Place: Courtyard Marriott, 2700 

Eisenhower Avenue, Alexandria, Virginia 

22314–4553, Telephone (703) 329–2323. 

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 ‘‘Occupational Safety and 

Health Training Project Grant, PAR 10–288.’’ 

Contact Person for More Information: M. 

Chris Langub, PhD, Scientific Review Officer, 

CDC, 1600 Clifton Road NE., Mailstop E74, 

Atlanta, Georgia 30333, Telephone (404) 

498–2543. 

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: February 14, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–4197 Filed 2–23–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0622] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Color Additive 

Certification Requests and 

Recordkeeping 

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 March 28, 

2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0216. 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, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 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. Color Additive 

Certification Requests and 

Recordkeeping—21 CFR part 80 (OMB 

Control Number 0910–0216)— 

Extension. 

FDA has regulatory oversight for color 

additives used in foods, drugs, 

cosmetics, and medical devices. Section 

721(a) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

379e(a)) provides that a color additive 

shall be deemed to be unsafe unless it 


emcdonald on DSK2BSOYB1PROD with NOTICES
10372 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 

meets the requirements of a listing 

regulation, including any requirement 

for batch certification, and is used in 

accordance with the regulation. FDA 

lists color additives that have been 

shown to be safe for their intended uses 

in Title 21 of the Code of Federal 

Regulations (CFR). FDA requires batch 

certification for all color additives listed 

in 21 CFR part 74 and for all color 

additives provisionally listed in 21 CFR 

part 82. Color additives listed in 21 CFR 

part 73 are exempted from certification. 

The requirements for color additive 

certification are described in part 80 (21 

CFR part 80). In the certification 

procedure, a representative sample of a 

new batch of color additive, 

accompanied by a ‘‘request for 

certification’’ that provides information 

about the batch, must be submitted to 

FDA’s Office of Cosmetics and Colors. 

FDA personnel perform chemical and 

other analyses of the representative 

sample and, providing the sample 

satisfies all certification requirements, 

issue a certification lot number for the 

batch. FDA charges a fee for certification 

based on the batch weight and requires 

manufacturers to keep records of the 

batch pending and after certification. 

Under § 80.21, a request for 

certification must include: Name of 

color additive, manufacturer’s batch 

number and weight in pounds, name 

and address of manufacturer, storage 

conditions, statement of use(s), 

certification fee, and signature of person 

requesting certification. Under § 80.22, a 

request for certification must include a 

sample of the batch of color additive 

that is the subject of the request. The 

sample must be labeled to show: Name 

of color additive, manufacturer’s batch 

number and quantity, and name and 

address of person requesting 

certification. Under § 80.39, the person 

to whom a certificate is issued must 

keep complete records showing the 

disposal of all the color additive 

covered by the certificate. Such records 

are to be made available upon request to 

any accredited representative of FDA 

until at least 2 years after disposal of all 

of the color additive. 

The purpose for collecting this 

information is to help FDA assure that 

only safe color additives will be used in 

foods, drugs, cosmetics, and medical 

devices sold in the United States. The 

required information is unique to the 

batch of color additive that is the subject 

of a request for certification. The 

manufacturer’s batch number is used for 

temporarily identifying a batch of color 

additive until FDA issues a certification 

lot number and for identifying a 

certified batch during inspections. The 

manufacturer’s batch number also aids 

in tracing the disposal of a certified 

batch or a batch that has been denied 

certification for noncompliance with the 

color additive regulations. The 

manufacturer’s batch weight is used for 

assessing the certification fee. The batch 

weight also is used to account for the 

disposal of a batch of certified or 

certification-denied color additive. The 

batch weight can be used in a recall to 

determine whether all unused color 

additive in the batch has been recalled. 

The manufacturer’s name and address 

and the name and address of the person 

requesting certification are used to 

contact the person responsible should a 

question arise concerning compliance 

with the color additive regulations. 

Information on storage conditions 

pending certification is used to evaluate 

whether a batch of certified color 

additive is inadvertently or 

intentionally altered in a manner that 

would make the sample submitted for 

certification analysis unrepresentative 

of the batch. FDA checks storage 

information during inspections. 

Information on intended uses for a batch 

of color additive is used to assure that 

a batch of certified color additive will be 

used in accordance with the 

requirements of its listing regulation. 

The statement of the fee on a 

certification request is used for 

accounting purposes so that a person 

requesting certification can be notified 

promptly of any discrepancies. 

In the Federal Register of December 

13, 2010 (75 FR 77645), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

80.21 ................................................................ 32 185 5,920 0.17 1,006 

80.22 ................................................................ 32 185 5,920 0.05 296 

Total .......................................................... ............................ ............................ ............................ 0.22 1,302 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual frequency 

per recordkeeping 

Total annual 

records Hours per record Total hours 

80.39 ................................................................ 32 185 5,920 0.25 1,480 

Total .......................................................... ............................ ............................ ............................ ............................ 1,480 

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

FDA bases its estimate on its review of 

the certification requests received over 

the past 3 fiscal years (FY). The annual 

burden estimate for this information 

collection is 2,782 hours. The estimated 

reporting burden for this information 

collection is 1,302 hours and the 

estimated recordkeeping burden for this 

information collection is 1,480 hours. 

From FY 2008 to FY 2010, FDA 

processed an average of 5,932 responses 

(requests for certification of batches of 

color additives) per year. There were 32 

different respondents, corresponding to 

an average of approximately 185 

responses from each respondent per 

year. Using information from industry 

personnel, FDA estimates that an 

average of 0.22 hour per response is 

required for reporting (preparing 

certification requests and accompanying 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10373 

samples) and an average of 0.25 hour 

per response is required for 

recordkeeping. 

FDA’s Web-based color certification 

information system allows certifiers to 

request color certification online, follow 

their submissions through the process, 

and obtain information on account 

status. The system sends back the 

certification results electronically, 

allowing certifiers to sell their certified 

color before receiving hard copy 

certificates. Any delays in the system 

result only from shipment of color 

additive samples to FDA’s Office of 

Cosmetics and Colors for analysis. FDA 

has estimated a reduction in the hour 

burden for reporting from use of the 

Web-based system. 

Dated: February 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4155 Filed 2–23–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Patient Navigator 

Outreach and Chronic Disease 

Prevention Demonstration Program 

(OMB No. 0915–NEW)—[NEW] 

The Patient Navigator Outreach and 

Chronic Disease Prevention 

Demonstration Program (PNDP) 

authorizes funds for the development 

and operation of projects to provide 

patient navigator services to improve 

health outcomes for individuals with 

cancer and other chronic diseases, with 

a specific emphasis on health disparities 

populations. Award recipients are to use 

grant funds to recruit, assign, train, and 

employ patient navigators who have 

direct knowledge of the communities 

they serve to facilitate the care of those 

who are at risk for or who have cancer 

or other chronic diseases, including 

conducting outreach to health 

disparities populations. 

As authorized by the statute, an 

evaluation of the outcomes of the 

program must be submitted to Congress. 

The purpose of these data collection 

instruments, including navigated 

patient data intake, VR–12 health status, 

patient navigator survey, patient 

navigator encounter/tracking log, 

patient medical record and clinic data, 

clinic rates (baseline measures), and 

quarterly reports is to provide data to 

inform and support the Report to 

Congress for: the quantitative analysis of 

baseline and benchmark measures; 

aggregate information about the patients 

served and program activities, and; 

recommendations on whether patient 

navigator programs could be used to 

improve patient outcomes in other 

public health areas. 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Navigated Patient Data Intake Form ....................................... 6,327 1 6,327 0 .5 3,163.5 

VR–12 Health Status Form ...................................................... 6,327 2 12,654 .12 1,519 

SubTotal—Patient Burden ................................................ 6,327 3 18,981 .62 4,682.5 

The annual estimate of burden is as follows: 

Patient Navigator Survey ......................................................... 46 1 46 0 .2 9.2 

Patient Navigator Encounter/Tracking Log .............................. 46 825 .3 37,962 0 .2 7,592.4 

SubTotal—Patient Navigator Burden ....................................... 46 826 .3 38,008 0 .4 7,601.6 

Patient Medical Record and Clinic Data .................................. 10 632 .7 6,327 .17 2,151.2 

Clinic Rates (Baseline Measures) ........................................... 10 1 10 10 100 

Quarterly Report ...................................................................... 10 4 40 1 40 

SubTotal—Grantee Burden .............................................. 30 637 .7 6,377 11 .17 2,291.2 

Totals ................................................................................ 6,403 ...................... 63,366 ...................... 14,575.3 

Total Average Annual Burden ................................... ........................ ...................... ........................ ...................... 14,575.3 

Anticipated Number of Patients per 

Site: 

Over 3 years 

Clinica Sierra Vista ............... 2,280 

Over 3 years 

CMAP ................................... 1,000 

New River ............................. 7,200 

Project Concern .................... 450 

Queens Medical Center ........ 500 

Over 3 years 

South County ........................ 600 

Texas Tech ........................... 200 

University of Utah ................. 1,350 

Vista ...................................... 3,000 


emcdonald on DSK2BSOYB1PROD with NOTICES