Proposed Data Collection Submitted for Public Comment and Recommendations

CourtCenters For Disease Control And Prevention
Citation87 FR 11442
Record Number2022-04191
Published date01 March 2022
Federal Register, Volume 87 Issue 40 (Tuesday, March 1, 2022)
[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
                [Notices]
                [Pages 11442-11444]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2022-04191]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Disease Control and Prevention
                [60Day-22-0010; Docket No. CDC-2022-0030]
                Proposed Data Collection Submitted for Public Comment and
                Recommendations
                AGENCY: Centers for Disease Control and Prevention (CDC), Department of
                Health and Human Services (HHS).
                ACTION: Notice with comment period.
                -----------------------------------------------------------------------
                SUMMARY: 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 the opportunity to comment on a proposed and/or
                continuing information collection, as required by the Paperwork
                Reduction Act of 1995. This notice invites comment on a proposed
                information collection project titled Birth Defects Study To Evaluate
                Pregnancy exposureS (BD-STEPS). Data from BD-STEPS will play an
                important part in the decision-making process that determines federal
                research agendas, birth defect prevention activities, and the direction
                of funding programs such as cooperative agreements.
                DATES: CDC must receive written comments on or before May 2, 2022.
                ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
                0030 by either of the following methods:
                 Federal eRulemaking Portal: Regulations.gov. Follow the
                instructions for submitting comments.
                 Mail: Jeffrey M. Zirger, Information Collection Review
                Office, Centers for Disease Control and Prevention, 1600 Clifton Road
                NE, MS H21-8, Atlanta, Georgia 30329.
                 Instructions: All submissions received must include the agency name
                and Docket Number. CDC will post, without change, all relevant comments
                to regulations.gov.
                 Please note: Submit all comments through the Federal eRulemaking
                portal (regulations.gov) or by U.S. mail to the address listed above.
                FOR FURTHER INFORMATION CONTACT: To request more information on the
                proposed project or to obtain a copy of the information collection plan
                and instruments, contact Jeffrey M. Zirger, Information Collection
                Review Office, Centers for Disease Control and Prevention, 1600 Clifton
                Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
                [email protected].
                SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
                (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
                the Office of Management and Budget (OMB) for each collection of
                information they conduct or sponsor. In addition, the PRA also requires
                federal agencies to provide a 60-day notice in the Federal Register
                concerning each proposed collection of information, including each new
                proposed collection, each proposed extension of existing collection of
                information, and each reinstatement of previously approved information
                collection before submitting the collection to the OMB for approval. To
                comply with this requirement, we are publishing this notice of a
                proposed data collection as described below.
                 The OMB is particularly interested in comments that will help:
                 1. 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;
                 2. Evaluate the accuracy of the agency's estimate of the burden of
                the proposed collection of information, including the validity of the
                methodology and assumptions used;
                 3. Enhance the quality, utility, and clarity of the information to
                be collected;
                 4. 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
                submissions of responses; and
                 5. Assess information collection costs.
                Proposed Project
                 Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS) (OMB
                Control No. 0920-0010, Exp. 2/28/2023)--Extension--National Center on
                Birth Defects and Developmental Disabilities (NCBDDD), Centers for
                Disease Control and Prevention (CDC).
                Background and Brief Description
                 Birth defects are associated with substantial morbidity and
                mortality in the United States. About one in every 33 babies is born
                with a birth defect. Birth defects contributed to more than one million
                hospital stays in the U.S. in 2013, resulting in $22.9 billion in
                hospital costs. Birth defects are the leading cause of infant mortality
                and the fifth leading cause of loss of potential years of life before
                age 65. One in five infant deaths is due to birth defects.
                 For most birth defects, the causes are not known, making prevention
                efforts challenging to develop. However, to date, primary preventive
                measures are available for only a few birth defects. For example,
                vaccination programs have reduced the incidence of congenital rubella
                syndrome, Rh hemolytic disease of the newborn can be prevented by
                appropriate medical practices, and genetic counseling can provide
                parents with information about the increased risk of Down syndrome
                associated with advanced maternal age. Perhaps most importantly, folic
                acid intake before and during pregnancy can prevent many cases of fatal
                or permanently disabling neural tube defects such as anencephaly and
                spina bifida.
                 This continued burden justifies reasonable attempts to reduce the
                [[Page 11443]]
                prevalence of birth defects. To help reduce birth defects among U.S.
                babies, in 1996 Congress directed the CDC to establish Centers of
                Excellence for Birth Defects Research and Prevention. The mandate was
                formalized with passage of the Birth Defects Prevention Act of 1998.
                The Act amended Section 317C of the Public Health Service Act (42
                U.S.C. 247b-4) and authorized CDC to (1) collect, analyze, and make
                available data on birth defects; (2) operate regional centers that will
                conduct applied epidemiological research for the prevention of birth
                defects; and (3) provide the public with information on preventing
                birth defects.
                 In response to this mandate, the Division of Birth Defects and
                Infant Disorders (DBDID) obtained OMB clearance for data collection
                that is carried out by the Centers for Birth Defects Research and
                Prevention (CBDRP). The CBDRP's first research effort was the National
                Birth Defects Prevention Study (NBDPS), which began data collection in
                1997 and ended in 2013. The CBDRPs transitioned from NBDPS to the Birth
                Defects Study To Evaluate Pregnancy exposures (BD-STEPS), which began
                data collection in 2014. One of the main activities for each Center is
                to conduct BD-STEPS in their state.
                 BD-STEPS is made up of a number of information collection
                activities. The interview is estimated to take approximately 55 minutes
                and is titled ``Birth Defects Prevention Study: Computer Assisted
                Telephone Interview.'' For the five Centers not participating in the
                stillbirth component of the study, a maximum of 370 interviews are
                planned per year per center, 270 cases and 100 controls; for the two
                Centers participating in additional stillbirth interviews, 590
                interviews are planned per Center, 270 cases with birth defects, 100
                controls, and 220 stillbirths without birth defects. With seven Centers
                and a maximum of 3,030 interviews, the maximum interview burden for all
                Centers combined would be 2,778 hours per year. The 55-minute burden
                includes the time for the telephone consent script which is reviewed
                with the mother at the beginning of the call to collect the information
                via the computer assisted telephone interview (CATI).
                 Five of the seven BD-STEPS Centers request consent for retrieval of
                leftover newborn bloodspots. If a maximum of 2,590 interviews would be
                expected for seven Centers (not including interviews of stillbirths
                without birth defects), a maximum of 1,850 would be expected for five
                Centers requesting consent for retrieval of leftover newborn bloodspots
                (excluding stillbirths, for which newborn bloodspots are not
                available). A maximum of 15 minutes would be expected for the
                participant to read the bloodspot retrieval consent request and sign
                the consent form. The anticipated maximum burden for bloodspot consent
                would be 463 hours annually.
                 With a maximum of 2,590 interviews planned annually (not including
                interviews of stillbirths without birth defects since they are not
                eligible for the online questionnaire), and approximately one-third of
                the respondents eligible for the online questionnaire (selected based
                on reporting occupations queried in the questionnaire), a maximum of
                830 women would receive the online questionnaire. Completion of the
                online questionnaire is estimated to take 20 minutes including reading
                introductory communication. The anticipated maximum burden for the
                online questionnaire is 277 hours annually.
                 CDC requests the release of reportable infectious diseases
                information from all women who complete the CATI except for women who
                experienced a stillbirth without a birth defect. A maximum of 2,590
                women would receive the infectious disease information request. Based
                on experience with consent forms, we expect the review, signing and
                mailing of the release of reportable infectious diseases information to
                take a maximum of 15 minutes for participants. The anticipated maximum
                burden for the reportable infectious diseases information is 648 hours
                annually.
                 In the two Centers participating in the supplemental interview,
                mothers of infants with or without birth defects that are stillborn and
                controls are asked to participate in a supplemental telephone
                interview. The 25-minute supplemental interview includes the time for
                informed consent. Based on a maximum of 640 women to be interviewed
                with the supplemental questionnaire, the maximum burden time would be
                267 hours annually.
                 Although participation rates may vary, the total estimates of
                annual burden hours for all activities, all individuals, and all
                Centers is 4,433 hours. There is no cost to respondents other than
                their time to participate.
                 Estimated Annualized Burden Hours
                ----------------------------------------------------------------------------------------------------------------
                 Number of Average burden
                 Type of respondents Form name Number of responses per per response Total burden
                 respondents respondent (in hours) (in hours)
                ----------------------------------------------------------------------------------------------------------------
                Mother's Interview............ Telephone 3,030 1 55/60 2,778
                 Consent Script/
                 BD-STEPS
                 Computer
                 Assisted
                 Telephone
                 Interview.
                Mother's Consent for Bloodspot Consent for 1,850 1 15/60 463
                 Retrieval. bloodspot
                 retrieval.
                Mother's Online Occupational Online 830 1 20/60 277
                 Questionnaire. Occupational
                 Questionnaire.
                Mothers Infectious Disease Infectious 2,590 1 15/60 648
                 Release Review. Disease Request
                 Form.
                Mothers of AR/MA Stillbirths Telephone 640 1 25/60 267
                 and Controls (Supplemental Consent and
                 Telephone Interview). Supplemental
                 Interview.
                 ---------------------------------------------------------------
                 Total................... ................ .............. .............. .............. 4,433
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                [[Page 11444]]
                Jeffrey M. Zirger,
                Lead, Information Collection Review Office, Office of Scientific
                Integrity, Office of Science, Centers for Disease Control and
                Prevention.
                [FR Doc. 2022-04191 Filed 2-28-22; 8:45 am]
                BILLING CODE 4163-18-P
                

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