81 FR 52436 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 152 (August 8, 2016)

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52436-52438]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0010]


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

[[Page 52437]]

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]. Direct written comments 
and/or suggestions regarding the items contained in this notice 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 an 
addition to the study population for two BD-STEPS Centers. 
Specifically, in these two Centers mothers of stillbirths without major 
birth defects will be added to the study population for BD-STEPS and 
mothers of all stillbirths (with and without birth defects) and all 
controls in these two Centers will be asked to participate in a 
supplemental telephone interview.
    The BD-STEPS interview takes approximately forty-five minutes to 
complete (burden estimate includes both the introductory telephone 
script/consent and questionnaire). For five Centers, a maximum of 275 
interviews are planned per year per center, 200 cases and 75 controls; 
for the two Centers participating in additional stillbirth interviews, 
495 interviews are planned per center, 200 cases with birth defects, 75 
controls, and 220 stillbirths without birth defects. With seven centers 
planned, the maximum interview burden for all centers combined would be 
approximately 1,774 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 
takes participants approximately 15 minutes to read, sign and return. 
In addition, it takes approximately 30 minutes for each medical record 
reviewer to conduct the review and send the medical record. The 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. In addition, in two Centers, mothers of stillbirths 
with and without birth defects and controls will be asked to 
participate in a supplemental telephone interview that will take 
approximately 25 minutes to complete.
    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 3,034. There are no costs to 
the respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
              Respondents                       Activity             Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Mothers (interview)...................  Telephone consent and BD-          2,365               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                  790               1           20/60
 questionnaire).                         Questionnaire.
Mothers (consent for medical records    Written release for                  475               1           15/60
 review).                                medical records review.
Records reviewers (medical records      Pulling and sending                  475               1           30/60
 review).                                records.
Mothers of all AR/MA stillbirths and    Telephone consent and                710               1           25/60
 controls (supplemental telephone        supplemental
 interview).                             questionnaire.
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[[Page 52438]]

Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-18746 Filed 8-5-16; 8:45 am]
 BILLING CODE 4163-18-P