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). 

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75814 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 

Background and Brief Description 

The Enhanced STD surveillance 

network Project is an active STD 

sentinel surveillance network 

comprised of 10 surveillance sites 

including Baltimore City Health 

Department, California Department of 

Public Health, Florida Department of 

Health, Massachusetts Department of 

Public Health, Minnesota Department of 

Health, Multnomah County Health 

Department, New York City Department 

of Health & Mental Hygiene, 

Philadelphia Department of Public 

Health, San Francisco Department of 

Public Health, and Washington State 

Department of Health. 

The purpose of eSSuN is to be a 

robust platform for the identification of 

STD trends, monitor STD epidemiology 

and evaluate the effectiveness of public 

health interventions through active 

surveillance collection, reporting, 

analysis, visualization (e.g., mapping) 

and interpretation of disease 

information. 

The objectives of the eSSuN project 

are (1) provide a dataset of 

supplemental information on gonorrhea 

case reports of STDs of interest; (2) 

provide geographic information on case 

reports of STDs of interest for 

investigating social determinants of 

STDs; (3) monitor screening coverage for 

chlamydial infection among young 

women in sentinel clinical settings; (4) 

monitor STD screening, incidence, 

prevalence, epidemiologic and health 

care access trends in populations of 

interest such as men-who-have-sex-with 

men (MSM), young people and persons 

diagnosed with gonorrhea; (5) monitor 

STD treatment and prevention service 

practices; (6) monitor selected adverse 

health outcomes of STDs; (7) evaluate 

and enhance local and state STD 

surveillance capacity; (8) enhance local 

STD-specific health information 

technology and epidemiologic capacity, 

and, (9) establish a core of exemplary 

state, tribal, territorial, county and/or 

city health department STD surveillance 

approaches to STD surveillance. 

This project will utilize two distinct 

surveillance strategies to collect 

information. The first strategy employs 

facility-based sentinel surveillance, 

which will abstract standardized data 

from existing electronic medical records 

for all patient visits to participating STD 

clinics and female patients aged 15–44 

years of age visiting participating family 

planning/reproductive health clinics 

and other facilities (school-based clinics 

and federally qualified healthcare 

centers) during the project period. The 

second strategy is population-based STD 

surveillance among a random sample of 

reported gonorrhea cases. Sampled 

cases will be contacted for standardized 

interview and the sample fraction will 

be 250 completed enhanced 

investigations or up to 2.5% of total 

morbidity if annual cases exceed 10,000 

cases. Enhanced investigations will also 

include verification of treatment and an 

internal health department record 

review (performed on either all cases or 

on the sampled cases). 

For the facility-based component of 

eSSuN, participating sites have 

developed common protocols 

stipulating data elements to be 

collected, including patient 

demographics, clinical, risk and sexual 

behaviors. The specified data elements 

are abstracted by clinic staff from 

existing electronic medical records for; 

(1) all patient visits to participating STD 

clinics, (2) female patients aged 15—24 

at participating family planning/

reproductive health clinics and, (3) 

visits of female patients aged 15–44 at 

school-based clinics and those attending 

federally qualified health centers 

(FQHCs) specifically for family planning 

services. 

Some of the participating facilities are 

satellites clinics of large network 

providers where clinical data systems 

are centralized. Hence, there are a total 

of 22 unique clinic data managers that 

will be abstracting the facility data. Each 

of the 22 clinic data managers will 

spend 3 hours to extract and transmit 

data to local/state health departments. 

Individual patient records are deidentified (all patient-specific identifiers 

are removed) by clinic staff before being 

transmitted to health departments, who 

recode the data into standardized 

formats before being transmitted to CDC 

through secure file transport 

mechanisms. Data transmission will 

occur on a monthly basis. Each eSSuN 

site will spend 16 hours to recode and 

transmit the data to CDC every month. 

At CDC, data will be aggregated across 

all participating sites in a common data 

structures and formatted for analysis. 

For the population-based surveillance 

component, a random sample of 

individuals residing within 

participating jurisdictions and reported 

with gonorrhea will be interviewed 

using locally designed interview 

templates following standardized data 

protocols. Enhanced data collection 

includes detailed information on 

demographic characteristics, behavioral 

risk factors and clinical history of 

persons with gonorrhea. Each of the 10 

sites will interview a minimum of 250 

persons (or up to 2.5% of total 

morbidity if annual GC cases exceed 

10,000 cases) and each interview is 

expected to take 10 minutes per person. 

Interview data for the population-based 

component will be collected through 

telephone administered or in-person 

interviews conducted by trained 

interviewers in the 10 eSSuN sites. 

These data will be directly entered into 

existing STD surveillance information 

systems at each health department. Data 

will be locally extracted, de-identified 

and recoded into standardized formats 

prior to being transmitted to CDC 

through secure file transport 

mechanisms on a monthly basis. 

Patient participation in the interview 

is voluntary and refusal to participate 

has no impact on other STD services the 

local health provides to persons 

diagnosed with gonorrhea. There is no 

cost to the respondents beyond their 

time and no compensation for 

participation. 

Both components of eSSuN are 

designed to (1) integrate traditional 

surveillance methods with innovative 

data management technologies to 

produce high-quality, timely 

surveillance and epidemiologic data, (2) 

provide valuable information to direct 

public health STD prevention and 

control efforts, (3) enhance 

understanding of the community burden 

of disease, (4) identify syndemic 

patterns and population at greatest risk, 

and, (5) monitor long-term health 

consequences of STDs. The eSSuN 

surveillance platform allows CDC to 

establish and maintain common 

standards for data collection, 

transmission, and analysis, and to build 

and maintain STD surveillance 

expertise in 10 state or city health 

departments. Such common systems, 

established mechanisms of 

communication, and in-place expertise 

are all critical components for timely, 

flexible, and high quality surveillance. 

The total estimated annual burden is 

2,854 hours of effort. 

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Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 75815 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Clinic Data manager at clinic .......................... Data Manager electronic Transmission .........

Record Abstraction (No Form) .......................

22 6 3 

Health Department Data Manager .................. Case Reports (No Form) ............................... 10 12 16 

Gonorrhea Patients sampled and interviewed Patient Interview ............................................. 3,225 1 10/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–29715 Filed 12–18–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10536 and 

CMS–R–262] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by January 20, 2015. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicaid 

Eligibility and Enrollment (EE) 

Implementation Advanced Planning 

Document (IAPD) Template; Use: To 

assess the appropriateness of states’ 

requests for enhanced federal financial 

participation for expenditures related to 

Medicaid eligibility determination 

systems, we will review the submitted 

information and documentation to make 

an approval determination for the 

advanced planning document. The 

package has been revised subsequent to 

the publication of the 60-day Federal 

Register notice (79 FR 51571). Form 

Number: CMS–10536 (OMB control 

number: 0938–New); Frequency: Yearly, 

once, and occasionally; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 168; Total Annual 

Hours: 1,344. (For policy questions 

regarding this collection contact 

Christine Gerhardt at 410–786–0693). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2016 Plan 

Benefit Package (PBP) Software and 

Formulary Submission; Use: We require 

that Medicare Advantage and 

Prescription Drug Plan organizations 

submit a completed PBP and formulary 

as part of the annual bidding process. 

During this process, organizations 

prepare their proposed plan benefit 

packages for the upcoming contract year 

and submit them to us for review and 

approval. We publish beneficiary 

education information using a variety of 

formats. The specific education 

initiatives that utilize PBP and 

formulary data include web application 

tools on www.medicare.gov and the plan 

benefit insert in the Medicare & You 

handbook. In addition, organizations 

utilize the PBP data to generate their 

Summary of Benefits marketing 

information. Please note that the 

package has been revised subsequent to 

the publication of the 60-day Federal 

Register notice (79 FR 57931). Form 

Number: CMS–R–262 (OMB control 

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