75812 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 

1Food and Nutrition Board, Institute of Medicine. 

1994. How Should the Recommended Dietary 

Allowances Be Revised? National Academy Press, 

Washington, DC. 

2 Dietary Reference Intakes: A Risk Assessment 

Model for Establishing Upper Intake Levels for 

Nutrients. National Academy Press, Washington, 

DC. 

adoption and implementation, or impact 

on health services outcomes. There is a 

need, then, to collect information from 

health and health care organizations to 

understand how and to what extent the 

National CLAS Standards have been 

utilized by its intended audiences. 

Likely Respondents: The information to 

be collected as part of this assessment 

will come from five categories of 

respondents: Training and Development 

Specialists and Managers; Other 

Management; Health and Health Care 

Organization Executives and Managers; 

Health and Health Care Providers, 

Managers, and Support Staff; Health 

Care Practitioners; and Technical Staff. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Type of 

respondent 

Number of 

respondent 

Number 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total burden 

(hours) 

National CLAS Standards Stakeholder Interview.Training and Development Specialists and Managers; Other Management Occupations (that contributed to development of National CLAS Standards).21 1 45/60 16 

CLAS Stakeholder Interview ............. Training and Development Specialists and Managers; Other Management Occupations (with subject matter expertise in cultural 

competence or cultural and linguistic appropriate services).

21 1 1 21 

Health and Health Care Organization 

Leadership Interview.

Health and Health Care Organization Executives and Managers.140 1 1 140 

Health and Health Care Organization 

Staff Survey.

Health and Health Care Providers, 

Managers, and Support Staff.

2,500 1 15/60 625 

Health and Health Care Organization 

Screener Survey.

Health and Health Care Organization Executives.50,000 1 5/60 4,167 

National CLAS Standards Experience Form.Health Care Practitioners and Technical Occupations.240,000 1 10/60 40,000 

Total ........................................... ........................................................... ........................ ........................ ........................ 44,969 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2014–29740 Filed 12–18–14; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of a Workshop and a 

Request for Public Comment on 

Questions Regarding Dietary 

Reference Intakes and Chronic 

Disease Endpoints 

AGENCY: Office of Disease Prevention 

and Health Promotion, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Dietary Reference Intakes 

(DRI) Committees of the U.S. and 

Canadian governments will hold a 

workshop entitled ‘‘Options for 

Consideration of Chronic Disease 

Endpoints for Dietary Reference 

Intakes.’’ The objective of the workshop 

is to critically evaluate key scientific 

issues involved in using chronic disease 

endpoints for setting DRIs and, in this 

context, to provide information for 

future decisions as to whether and/or 

how chronic disease endpoints can be 

incorporated into the setting of DRI 

values. In preparation for this meeting, 

the DRI Committees are asking for 

public comment on the set of questions 

that the meeting panelists will discuss. 

DATES: This meeting will be held on 

March 10, 2015 from 8:30 a.m. to 5:00 

p.m. E.D.T. and on March 11, 2015 from 

8:30 a.m. to 12:30 p.m. E.D.T. 

ADDRESSES: The workshop will be held 

at the Lister Hill Auditorium, National 

Institutes of Health, in Bethesda, 

Maryland, USA. The workshop will be 

open to the public either in-person 

(seating is limited) or by videocast on 

the Internet. 

FOR FURTHER INFORMATION CONTACT: 

Additional information about this 

workshop and the agenda will be made 

available on the Internet at http://

www.health.gov/dri/as the meeting 

approaches. You may also send emails 

to DRI@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background Information 

The current DRI approaches for 

selecting indicators of adequacy and 

toxicity and for estimating doseresponse relationships between nutrient 

intakes and selected outcomes derive 

from several Food and Nutrition Board 

committee reports published by the 

Institute of Medicine (IOM) in 1994 1

and 1998.2 These committees 

recommended that DRIs for adequacy be 

expressed as Estimated Average 

Requirements (EARs) and 

Recommended Dietary Allowances 

(RDAs, representing 97.5% of 

population requirements). They also 

recommended that reference values for 

Tolerable Upper Intake Levels (ULs) be 

included in future DRI evaluations. 

Additionally, the 1994 IOM committee 

concluded that future RDA processes 

(now called DRIs) should include the 

concept of chronic disease risk 

reduction in addition to the classical 

nutrient deficiency endpoints. The 

approaches recommended by the 1994 

and 1998 committees were applied, 

with a few additions (e.g., Adequate 

Intakes, Acceptable Macronutrient 

Distribution Ranges), for all seven of the 

DRI reviews published from 1997 to 

2011. These reports can be accessed at 

the following Web site: http://

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 75813 

3The Development of DRIs 1994–2004: Lessons 

Learned and New Challenges, Workshop Summary, 

November 30, 2007. Available from: http://

www.iom.edu/Reports/2007/The-Development-ofDRIs-1994-2004-Lessons-Learned-and-NewChallenges-Workshop-Summary.aspx. 

fnic.nal.usda.gov/dietary-guidance/

dietary-reference-intakes/dri-reports. 

It has become apparent that a number 

of unanticipated challenges were 

encountered when chronic disease 

endpoints were considered as indicators 

for setting DRI reference values. Many of 

these challenges were discussed in a 

2007 ‘‘lessons learned’’ workshop 

conducted by the IOM after the first six 

DRI reports were published.3 Other 

scientific publications have also 

discussed the challenges, but 

approaches for addressing the identified 

challenges have not yet been adequately 

explored. 

Recently, the DRI Committees of the 

U.S. and Canadian governments called 

for nominations for nutrients to be 

considered for future DRI reviews. Many 

of the nominated nutrients cited new 

data on chronic disease relationships as 

the justification for new DRI reviews, 

including three of the four nutrients 

selected by the DRI Committees for 

further consideration based on the 

availability of sufficient new and 

relevant evidence. Given the clear need 

for more in-depth evaluation of the 

challenges involved in incorporating 

chronic disease endpoints into DRI 

processes prior to initiating a new DRI 

review, the two government committees 

announced plans to sponsor a workshop 

to be held in 2015 to address whether, 

and how, chronic disease outcomes can 

be incorporated into the process of 

setting DRI values. 

The limited time available for the 

workshop may preclude consideration 

of all issues relevant to the 

incorporation of chronic disease 

endpoints into DRI processes. As 

warranted, subsequent activities will 

address issues that arise in the 

workshop or that have been identified 

in other activities but not covered in 

workshop discussions. 

Written Public Comments 

The key questions for the workshop, 

on which the committees would like 

public comments, are derived from prior 

discussions of the major challenges in 

incorporating chronic disease endpoints 

into DRI considerations: 

1. What dose-response models can be 

considered for future DRI reviews when 

chronic disease endpoints are used? 

a. What are the scientific issues? 

b. What are the options for addressing 

these issues? 

c. What are the advantages and 

disadvantages of the various options? 

2. What are the evidentiary challenges 

important in selecting and using chronic 

disease endpoints in future DRI 

reviews? 

a. What are the scientific issues? 

b. What are the options for addressing 

these issues? 

c. What are the advantages and 

disadvantages of the various options? 

3. What arguments can be made for 

and against continuing to include 

chronic disease endpoints in future DRI 

reviews? 

a. What are the scientific issues? 

b. What are the options for addressing 

these issues? 

c. What are the advantages and 

disadvantages of the various options? 

Public comments are to be submitted via 

email to DRI@hhs.gov. Provide a brief 

summary (approx. 250 words) of the 

points or issues. If providing literature 

or other resources, one of the following 

forms is preferred: 

• Complete citation, as in a 

bibliographic entry 

• Abstract 

• Electronic link to full article or report 

Please provide comments as early as 

possible in order to increase the 

likelihood of having a meaningful 

impact, as the workshop panelists will 

be considering them prior to the 

workshop. The deadline for comment 

submission is Friday, January 30, 2015. 

Comments received later than January 

30, 2015 will not be considered. 

Meeting Registration: The meeting 

will be publicly accessible both inperson and by videocast on the Internet. 

Due to limited seating capacity, 

registration will be required for inperson attendance. Notice of registration 

will be available on http://

www.health.gov/dri/prior to the 

workshop; registration is expected to 

open on or about February 15, 2015. 

Dated: December 16, 2014. 

Don Wright, 

Deputy Assistant Secretary for Health, 

Office of Disease Prevention and Health 

Promotion, 

Office of the Assistant Secretary for Health, 

U.S. Department of Health and Human 

Services. 

[FR Doc. 2014–29766 Filed 12–18–14; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–14AQA] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

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 

The Enhanced STD Surveillance 

Network (eSSuN)—NEW—Division of 

STD Prevention (DSTDP), National 

Center for HIV/AIDS, Viral Hepatitis, 

STD, and TB prevention (NCHHSTP), 

Centers for Disease Control and 

Prevention (CDC). 

mstockstill on DSK4VPTVN1PROD with NOTICES