Public comment

Attachment 2B

Comments Received from 60 day Federal Registry

One non-substantive comment received. CDC’s standard response was sent.

From: jean public [mailto:[email protected]]
Sent: Monday, August 11, 2014 10:56 AM
To: OMB-Comments (CDC); INFO; media
Subject: Re: ALL FUNDS FOR THIS PROJECT SHOULD BE CUT TO ZERO

PUBILC COMMENT ON FEDERAL REGISTGER

THE TAXPAYERS OF THIS COUNTRY ARE BEING ASKED TO SPEND TOO MUCH ON THIS ISSUE. THEY HAVE SPENT TRILLIONS OF DOLLARS AND ITS TIME TO START CUTTING DOWN ON THIS ISSUE AND MNAKING SURE THOSE WHO REQUIRE THIS KIND OF HELP ESTABLISH THEIR OWN PRIVATE FUNDED AGENCIES FUNDED WITH THEIR OWN DOLLARS TO KEEP ON THIS PATH. WE CANNOT CONTINUE TO EXTORT AND GOUGE ALL AMERICAN TAXPAYERS FOR THIE OUT OF CONTROL COSTS IN THIS ISSUE. WE NEED SMALLER CHEAPER GOVT. YOUR SPENDING ON THIS HAS GONE WAY WAY OUT OF CONTROL. CUT THE BUDGET HERE BY 50%. THIS COMMENT IS FOR THE PUBLIC RECORD. PLEASE RECEIPT. JEAN PUBLIC

On Mon, Aug 11, 2014 at 8:35 AM, Jean Public <[email protected]> wrote:

[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]

[Notices]

[Pages 46825-46827]

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

[FR Doc No: 2014-18845]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-14AQA]

Proposed Data Collections Submitted for Public Comment and

Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of

its continuing effort to reduce public burden, invites the general

public and other Federal agencies to take this opportunity to comment

on proposed and/or continuing information collections, as required by

the Paperwork Reduction Act of 1995. To request more information on the

below proposed project or to obtain a copy of the information

collection plan and instruments, call 404-639-7570 or send comments to

Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send

an email to [email protected].

    Comments submitted in response to this notice will be summarized

and/or included in the request for Office of Management and Budget

(OMB) approval. Comments are invited on: (a) Whether the proposed

collection of information is necessary for the proper performance of

the functions of the agency, including whether the information shall

have practical utility; (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; (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; and (e)

estimates of capital or start-up costs and costs of operation,

maintenance, and purchase of services to provide information. Burden

means the total time, effort, or financial resources expended by

persons to generate, maintain, retain, disclose or provide information

to or for a Federal agency. This includes the time needed to review

instructions; to develop, acquire, install and utilize technology and

systems for the purpose of collecting, validating and verifying

information, processing and maintaining information, and disclosing and

providing information; to train personnel and to be able to respond to

a collection of information, to search data sources, to complete and

review the collection of information; and to transmit or otherwise

disclose the information. Written comments should be received within 60

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).

[[Page 46826]]

Background and Brief Description

    The Enhanced STD Surveillance Network (eSSuN) 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 enhanced STD Surveillance Network is a sentinel surveillance

initiative designed to collect longitudinal data of a magnitude

sufficient to detect trends and changes over time in the clinical and

demographic characteristics of persons presenting for care in STD and

family planning/reproductive health clinical facilities and those being

diagnosed and reported with gonorrhea in funded jurisdictions. Data

collection activities will be ongoing and continuous and will take five

years to complete to establish annual trends, allowing for accretion of

a sufficient number of investigated cases or patient visits to detect

statistically meaningful differences between population sub groups.

    While routine STD surveillance activities are ongoing in all states

and jurisdictions through the National Notifiable Disease Surveillance

System, these data do not include the patient populations and specific

clinical data elements and behavioral data proposed for collection in

eSSuN. No other sources of information currently collected by, or

available to, CDC answer the specific questions eSSuN is designed to

answer.

    A similar data collection infrastructure, the STD Surveillance

Network (OMB No. 0920-0842), expires on September 30th, 2015. However,

funding for this cooperative agreement ended in September 29th, 2013

and the protocols have been retired. The enhanced STD network is not a

continuation of SSuN, instead, it is a new initiative to collect

different kinds of data in different jurisdictions and to respond to

different national objectives.

    The objectives of the eSSuN Project are (1) provide a dataset of

supplemental information on 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

services 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 programs employing innovative approaches to STD

surveillance.

    This project collects data using two surveillance strategies; (1)

enhanced surveillance in participating STD and Family planning/

reproductive health clinics and (2) enhanced gonorrhea surveillance on

a random sample of persons diagnosed with gonorrhea in participating

jurisdictions of these 10 local and state health departments.

    For the clinic-based surveillance, participating sites have

developed common protocols stipulating which data elements would be

collected, including demographic, clinical, risk and sexual behaviors.

The specified data elements are abstracted from existing electronic

medical records for (1) all patient visits to participating STD clinics

and (2) for all female patient visits aged 15-44 years of age to

participating family planning/reproductive health clinics. Data are de-

identified and recoded by health departments and then are transmitted

to CDC through secure file transport mechanisms on an every two month

basis. Each eSSuN site will spend 16 hours to transmit the data to CDC

every two months. At CDC, data will be aggregated with data from all

participating sites in a common language and formatted for analysis.

    For the population-based surveillance, a random sample of

individuals reported with gonorrhea residing within participating

jurisdictions are interviewed using locally designed interview

templates.

    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 2.5% of total morbidity if annual GC cases

exceed 10,000 cases and each interview is expected to take about 10

minutes per person. 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.

    The survey results will be entered into the existing information

systems at each health department and sent to CDC through secure file

transport mechanisms on an every two month basis.

    This information is being collected to (1) enhance and improve STD

surveillance data, (2) inform a more comprehensive understanding of

tends and determinants of STDs of interest, (3) monitor public health

program impact and (4) provide a more robust evidence base for

directing public health action in the US.

    Participation is voluntary. There is no cost to the respondents

other than their time.

                                          Estimate of Annualized Burden

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                                                                                      Average

                                                     Number of       Number of      burden per     Total burden

      Type of respondent            Form name       respondents    responses per     response          hours

                                                                    respondent        (hours)

----------------------------------------------------------------------------------------------------------------

Data manager at clinic          Record                        33               6               3             594

(Electronic transmittal of      Abstraction.

clinical variables in clinic

databases).

Data manager at each of the 10  Record                        10              12              16            1920

local/state health department.  Abstraction.

Gonorrhea cases sampled.......  Telephone/in-              3,225               1           10/60             538

                                 person

                                 interview.

                                                 ---------------------------------------------------------------

    Total.....................  ................  ..............  ..............  ..............           3,050

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[[Page 46827]]

LeRoy 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. 2014-18845 Filed 8-8-14; 8:45 am]

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