[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14553-14554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05236]



[[Page 14553]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-13-13LD]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to Ron Otten, at 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email to [email protected].
    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; 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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Formative Research, Messages and Materials Development for Birth 
Defects and Developmental Disabilities, Human Development and 
Disabilities, and Blood Disorders--NEW--Centers for Disease Control and 
Prevention (CDC), National Center on Birth Defects and Developmental 
Disabilities (NCBDDD).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), National 
Center on Birth Defects and Developmental Disabilities (NCBDDD), 
requests approval for a new generic information collection package that 
supports formative research in birth defects and developmental 
disabilities; human development and disabilities, and blood disorders. 
Identified priority diseases, disorders, and conditions included in 
this information collection activity include but are not limited to 
preconception health; autism spectrum disorders (ASDs) and other 
developmental disabilities; fetal alcohol spectrum disorders (FASDs); 
neural tube defects (spina bifida, anencephaly); muscular dystrophy; 
fragile X; deep vein thrombosis/pulmonary embolism (DVT/PE); sickle 
cell disease (SCD); attention-deficit/hyperactivity disorder (ADHD); 
and Tourette syndrome.
    The Children's Health Act of 2000 required the establishment of 
NCBDDD. The Center is organized into three divisions, which are focused 
on birth defects and developmental disabilities, human development and 
disabilities, and blood disorders. NCBDDD promotes the health of 
babies, children and adults and focuses on identifying the causes of 
and prevention of birth defects and developmental disabilities; helping 
children to develop and reach their potential for full, productive 
living; and optimizing the health outcomes among people of all ages 
with disabilities. These goals are accomplished through research, 
partnerships, and prevention and education programs.
    Birth defects affect 1 in 33 babies and are a leading cause of 
infant death in the United States. More than 5,500 infants die each 
year due to birth defects. Additionally, over 500,000 children are 
diagnosed with a developmental disability. With more information, the 
causes of these birth defects and developmental disabilities can be 
identified and action can be taken to protect children and to develop 
new ways to help women have healthy babies.
    Disabilities can affect anyone of any age. About 1 in 5 Americans 
report having some level of disability. People with disabilities need 
health care and health programs to stay well, active, and a part of the 
community. To be healthy, people with disabilities require health care 
that meets their needs as a whole person, not just as a person with a 
disability.
    Blood disorders such as sickle cell disease, anemia, and 
hemophilia--affect millions of people each year in the United States, 
cutting across the boundaries of age, race, sex, and socioeconomic 
status. Men, women, and children of all backgrounds live with the 
complications associated with these conditions, many of which are 
painful and potentially life-threatening. With proper preventive 
actions and early intervention, many of these disorders and their 
complications could, to a large extent, be eliminated. NCBDDD is 
dedicated to reducing the public health burden resulting from these 
conditions by contributing to a better understanding of blood disorders 
and their complications; ensuring that prevention programs are 
developed, implemented, and evaluated; ensuring that information is 
accessible to consumers and health care providers; and encouraging 
action to improve the quality of life for people living with or 
affected by these conditions.
    The behavioral, clinical, and surveillance projects implemented by 
NCBDDD are the foundation upon which recommendations and guidelines are 
revised and updated. Formative research is the mechanism by which 
evidence is obtained for priority diseases in these three (3) health 
condition groups and by which recommendations and guidelines are 
revised and updated.
    NCBDDD conducts formative research for developing new messages, 
materials, and strategies that respond to the changing epidemiology of 
these priority health conditions. A generic clearance mechanism would 
increase productivity of CDC programs and improve the quality of public 
health interventions and health communication programs.
    The data collection and evidence are developed using a multitude of 
information sources including internal and external subject matter 
experts, field experience, consultation with external colleagues, 
piloting activities, and formal evaluations. The involvement of 
external and internal subject matter experts produces scientifically 
valid instruments, interventions, and methods that enable NCBDDD to be 
responsive to the changing epidemiology and community needs of these 
priority diseases. Targeted audience members or representatives provide 
the information for developing clear and influential health messages, 
materials, and strategies that promote health and well-being. An 
integrated research effort is needed to fill in gaps of knowledge, 
awareness, screening, and prevention behaviors and could simultaneously 
work to reduce stigma surrounding these topics within special 
populations, explore cultural issues, and increase the demand for, and 
uptake of screening by health care providers.
    Overall, these formative research activities are intended to 
provide information that will increase the success of the surveillance 
or research project through increasing response rates and decreasing 
response error thereby decreasing future data collection burden to the 
public.
    This request is submitted to obtain OMB clearance for three years. 
The estimates of annualized burden hours are based on past experience 
with recruitment and the administration of

[[Page 14554]]

similar surveys and focus groups. It is estimated that 80,500 
respondents will have to be screened annually to recruit the 
appropriate number of respondents for this data collection activity. 
Specific information will be provided with each individual project 
submission. The estimated annualized burden hours for this data 
collection activity is 49,667. There is no cost to respondents other 
than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
      Type of respondent            Form name        Number of     responses per   Average hours  Total response
                                                    respondents     respondent     per response   burden (hours)
----------------------------------------------------------------------------------------------------------------
General public and health care  Screener........          80,500               1           10/60          13,417
 providers.
General public and health care  Consent Forms...          30,000               1            5/60           2,500
 providers.
General public and health care  Moderator's               30,000               1               1          30,000
 providers.                      Guide.
General public and health care  Surveys.........          15,000               1           15/60           3,750
 providers.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          49,667
----------------------------------------------------------------------------------------------------------------


    Dated: February 28, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-05236 Filed 3-5-13; 8:45 am]
BILLING CODE 4163-18-P