80 FR 31380 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 105 (June 2, 2015)

[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31380-31381]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13385]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0010]


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 [email protected]. 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

    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 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. For approximately one 
fifth of participants, some medical records review will be conducted. 
The medical records release form will take participants approximately 
15 minutes to read, sign and return. In addition, it will take 
approximately 30 minutes for each medical record reviewer to conduct 
the review and send the medical record. 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 20 
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 2,290.
    There are no costs to the respondents other than their time.

[[Page 31381]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
              Respondents                       Activity            respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Mothers (interview)...................  Telephone consent and BD-          1,925               1           45/60
                                         STEPS questionnaire.
Mothers (consent for bloodspot          Written consent for                1,375               1           15/60
 retrieval).                             bloodspot retrieval.
Mothers (online occupational            Online Occupational                  642               1           20/60
 questionnaire).                         Questionnaire.
Mothers (consent for medical records    Written release for                  385               1           15/60
 review).                                medical records review.
Records reviewers (medical records      Pulling and sending                  385               1           30/60
 review).                                records.
----------------------------------------------------------------------------------------------------------------


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. 2015-13385 Filed 6-1-15; 8:45 am]
 BILLING CODE 4163-18-P