Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 52953 

questions about the caseload for the 

registry (the number of new cancer cases 

reported annually), the sources of case 

information, whether case information 

is collected utilizing manual or 

electronic methods, and the type of 

software employed for electronic 

collection. Because many tasks can be 

performed manually or using electronic 

methods, and because cancer coding 

systems are frequently revised to reflect 

changes in cancer diagnosis and care, 

the WLM survey asks registry managers 

to identify training needs that would 

improve registry productivity, and to 

provide comments about other resource 

needs and management issues. 

The web-based WLM Survey will also 

collect information about the total 

amount of time dedicated by registry 

staff to specific activities such as case 

finding, records abstraction, follow-up, 

quality assurance, professional 

development, travel, and death 

clearances. In order to complete this 

section of the WLM survey, detailed 

information will be collected from 

registry staff. An average of eight 

registrars in each registry will be asked 

to maintain a paper Work Activities 

Journal for a one-week period. Each 

registrar will record the number of 

hours and minutes dedicated to case 

finding, records abstraction, follow-up, 

and quality assurance, and where 

applicable, indicate whether tasks were 

conducted manually or electronically. 

In addition, each registrar will estimate 

the amount of time dedicated to 

auditing, database management, 

professional development, travel, and 

death clearances on a monthly or annual 

basis. At the end of the one-week data 

collection period, the registry manager 

will compile information from all of the 

Work Activities Journals completed by 

the registry’s staff. The aggregate 

information will be reported to CDC 

through the WLM Survey. The 

individual Work Activities Journals will 

not be submitted to CDC. 

Findings from the WLM survey will 

enable CDC to assess the workforce 

necessary for meeting data reporting 

requirements and to estimate the impact 

of planned changes to surveillance data 

reporting. CDC plans to develop 

guidance so that cancer registry 

managers can more effectively measure 

workload, evaluate the need for staff 

and staff credentials, and advocate for 

adequate staffing. 

OMB approval is requested for one 

year. Participation in the survey is 

voluntary. There are no costs to 

respondents other than their time. The 

total estimated annualized burden hours 

are 921. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

NPCR managers ............................................. Workload and Time Management Survey ..... 46 1 4 

Telephone Reminder ...................................... 15 1 3/60 

NPCR Staff Registrars .................................... Work Activities Journal ................................... 368 1 2 

Dated: August 23, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–21496 Filed 8–27–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–10–10AK] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 days of this notice. 

Proposed Project 

National Notifiable Condition 

Messaging Support Strategy—New— 

Public Health Surveillance Program 

Office (PHSPO); Office of Surveillance, 

Epidemiology, and Laboratory Services 

(OSELS), Centers for Disease Control 

and Prevention, (CDC). 

Background and Brief Description 

The Public Health Services Act (42 

U.S.C. 241) authorizes CDC to 

disseminate nationally notifiable 

condition information. CDC’s Morbidity 

and Mortality Weekly Report publishes 

incidence tables for nationally notifiable 

conditions reported through the 

National Electronic Disease Surveillance 

System (NEDSS) and other surveillance 

data sources to the National Notifiable 

Diseases Surveillance System (NNDSS). 

NEDSS (OMB 0920–0728, expiration 

date: 2/28/2010) is an internet-based 

infrastructure for public health 

surveillance data exchange that uses 

specific Public Health Information 

Network (PHIN) and NEDSS electronic 

data and information standards to 

advance the development of efficient, 

integrated, and interoperable 

surveillance systems at federal, state 

and local levels. CDC’s proposed Public 

Health Surveillance Program Office 

(PHSPO) is responsible for establishing 

and managing the national reporting 

system of epidemiologic data for 

notifiable conditions (diseases) via 

NEDSS. 

Case notification messaging for most 

of the nationally notifiable conditions 

(77 infectious conditions as of August 

2009) will eventually be supported by 

the standard Health Level 7 v2.5 (HL7) 

message format. The HL7 message 

format requires a Message Mapping 

Guide (MMG)—developed by the 

NEDSS and NNDSS programs, in 

collaboration with state and federal 

subject matter experts—to implement 

case notification to CDC via NEDSS. At 

present, seven MMGs are available for 

implementation by jurisdictions, and 

current NEDSS resources support the 

development of three new MMGs per 

year. A jurisdiction’s implementation of 

a MMG requires an average of four 

months per MMG, and a jurisdiction 

could potentially implement up to three 

MMGs a year. In most instances, 

National Center for Public Health 

Informatics’ (NCPHI) programmatic and 

technical expertise is required to 

support this process at the jurisdictional 

level. 

The National Notifiable Condition 

Messaging Support Strategy 


jlentini on DSKJ8SOYB1PROD with NOTICES
52954 Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 

Questionnaire has been developed by 

the NEDSS program to gather 

information needed for formulating a 

technical and project management 

support strategy for 57 reporting 

jurisdictions (i.e., 50 states, 5 territories, 

and 2 cities (New York City, NY and 

Washington, DC)) as they implement 

NEDSS messaging using MMGs. A 

jurisdiction’s response to the 

questionnaire will be used by the 

NEDSS implementation and 

management teams to assess the 

jurisdiction’s IT system environment 

and capacity and help determine the 

project schedule and level of human 

and technical support needed to 

complete the jurisdiction’s 

implementation of a nationally 

notifiable condition message. NEDSS 

infrastructure implementation support 

includes, but is not limited to 

implementing NEDSS Message 

Subscription Service (MSS) and NEDSS 

Messaging Solution (NMS) software in 

requesting jurisdictions; providing MSS 

and NMS software training and ongoing 

technical support; and distributing 

funding via the CDC Epidemiology and 

Laboratory Capacity cooperative 

agreement. 

Questionnaires will be distributed to 

jurisdictions that initiate MMG 

implementation for a condition; 

therefore, the maximum annual 

frequency of responses per jurisdiction 

is three. The NEDSS team will request 

the jurisdiction to voluntarily complete 

the questionnaire, but a response is not 

a pre-requisite for support. 

There is no cost to respondents other 

than their time to participate in the 

survey. The total estimated annual 

burden hours are 114. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

State, Territory and Local Public Health Department.National Notifiable Condition Messaging 

Support Strategy Questionnaire.

57 3 40/60 

Dated: August 23, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–21497 Filed 8–27–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0258] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Submission of 

Petitions: Food Additive, Color 

Additive (Including Labeling), and 

Generally Recognized as Safe 

Affirmation; Submission of Information 

to a Master File in Support of Petitions; 

Electronic Submission Using Food and 

Drug Administration Form 3503 

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 September 

29, 2010. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0016. 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. 

Submission of Petitions: Food Additive, 

Color Additive (Including Labeling), 

and Generally Recognized as Safe 

Affirmation; Submission of Information 

to a Master File in Support of Petitions; 

Electronic Submission Using FDA Form 

3503—21 CFR 70.25, 71.1, 170.35, 

171.1, 172, 173, 179, and 180 (OMB 

Control Number 0910–0016)—Revision 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe, 

unless: (1) The additive and its use, or 

intended use, are in conformity with a 

regulation issued under section 409 of 

the FD&C Act that describes the 

condition(s) under which the additive 

may be safely used; (2) the additive and 

its use, or intended use, conform to the 

terms of an exemption for 

investigational use; or (3) a food contact 

notification submitted under section 

409(h) of the FD&C Act is effective. 

Food additive petitions (FAPs) are 

submitted by individuals or companies 

to obtain approval of a new food 

additive or to amend the conditions of 

use permitted under an existing food 

additive regulation. Section 171.1 of 

FDA’s regulations (21 CFR 171.1) 

specifies the information that a 

petitioner must submit in order to 

establish that the proposed use of a food 

additive is safe and to secure the 

publication of a food additive regulation 

describing the conditions under which 

the additive may be safely used. Parts 

172, 173, 179, and 180 (21 CFR parts 

172, 173, 179, and 180) contain labeling 

requirements for certain food additives 

to ensure their safe use. 

Section 721(a) of the FD&C Act (21 

U.S.C. 379e(a)) provides that a color 

additive shall be deemed to be unsafe 

unless the additive and its use are in 

conformity with a regulation that 

describes the condition(s) under which 

the additive may safely be used, or the 

additive and its use conform to the 

terms of an exemption for 

investigational use issued under section 

721(f) of the FD&C Act. Color additive 

petitions (CAPs) are submitted by 

individuals or companies to obtain 

approval of a new color additive or a 

change in the conditions of use 

permitted for a color additive that is 

already approved. Section 71.1 of the 

agency’s regulations (21 CFR 71.1) 

specifies the information that a 


jlentini on DSKJ8SOYB1PROD with NOTICES