80 FR 8655 - Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 32 (February 18, 2015)

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8655-8656]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03245]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0010]


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 and maximize the utility 
of government information, 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 A. 
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

    Birth Defects Study To Evaluate Pregnancy exposures (BD-STEPS) 
(formerly titled The National Birth Defects Prevention Study (NBDPS)), 
(OMB 0920-0010, Expiration 01/31/2017)--Revision--National Center on 
Birth Defects and Developmental Disabilities (NCBDDD), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    CDC has been monitoring the occurrence of serious birth defects and 
genetic diseases in Atlanta since 1967 through the Metropolitan Atlanta 
Congenital Defects Program (MACDP). The MACDP is a population-based 
surveillance system for birth defects currently covering three counties 
in Metropolitan Atlanta.
    Since 1997, CDC has funded case-control studies of major birth 
defects that utilize existing birth defect surveillance registries 
(including

[[Page 8656]]

MACDP) to identify cases and study birth defects causes in 
participating states/municipalities across the United States.
    The current study, BD-STEPS, is a case-control study that is 
similar to the previous CDC-funded birth defects case-control study, 
NBDPS, which stopped interviewing participants in 2013. As with NBDPS, 
BD-STEPS control infants are randomly selected from birth certificates 
or birth hospital records; mothers of case and control infants are 
interviewed using a computer-assisted telephone interview.
    The results from NBDPS have improved understanding of the causes of 
birth defects. Over 200 articles have been written in professional 
journals using the data from NBDPS, and BD-STEPS data will soon be 
added to NBDPS data for analysis. The current BD-STEPS revision is a 
change in proposed data collection. Specifically, the study will not 
ask BD-STEPS participants to participate in saliva collection as 
originally planned, but we will add an opportunity for some 
participants to respond to an online questionnaire, and we will also 
ask some participants for permission to retrieve newborn bloodspots.
    The BD-STEPS interview takes approximately forty-five minutes to 
complete. A maximum of 275 interviews are planned per year per center, 
200 cases and 75 controls. With seven centers planned, the maximum 
interview burden for all centers combined would be approximately 1,444 
hours. Mothers in five of the seven BD-STEPS Centers will also be asked 
to provide consent for the study to access previously collected infant 
bloodspots. It takes approximately 15 minutes to read, sign and return 
the informed consent for retrieval of bloodspots. Finally, the newly 
planned online questionnaire will be offered to approximately one third 
of participants who report certain occupations during the telephone 
interview; these participants will be asked to complete additional 
occupational questions via a Web site which will take approximately 15 
minutes to answer.
    Information gathered from both the interviews and the 
Deoxyribonucleic acid specimens has been and will continue to be used 
to study independent genetic and environmental factors as well as gene-
environment interactions for a broad range of carefully classified 
birth defects.
    This request is submitted to revise the previously estimated burden 
details and to request OMB clearance for three additional years. The 
total estimated annual burden hours are 1,949.
    There are no costs to the respondents other than their time.

                                      Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
          Respondents               Activity         Number of     responses per   per response    Total burden
                                                    respondents     respondent      (In hours)         hours
----------------------------------------------------------------------------------------------------------------
Mothers (interview)...........  Telephone                  1,925               1           45/60           1,444
                                 consent and BD-
                                 STEPS
                                 questionnaire.
Mothers (consent for bloodspot  Written consent            1,375               1           15/60             344
 retrieval).                     for bloodspot
                                 retrieval.
Mothers (online occupational    Online                       642               1           15/60             161
 questionnaire).                 Occupational
                                 Questionnaire.
                               ---------------------------------------------------------------------------------
    TOTAL.....................  ................  ..............  ..............  ..............           1,949
----------------------------------------------------------------------------------------------------------------


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. 2015-03245 Filed 2-17-15; 8:45 am]
BILLING CODE 4163-18-P