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)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 32 (February 18, 2015)
| Page Range | 8655-8656 | |
| FR Document | 2015-03245 |
[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
![Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 8655
basic education and increase awareness original approval date, 4,250 items: race/ethnicity, sexual behavior,
of HIV/AIDS among the general public, respondents have participated in the and sexual orientation. Each survey will
and others will be targeted to specific surveys. The number of remaining have a core set of items asked in all
subgroups or communities at greatest respondents for the 3-year period is rounds, as well as a module of questions
risk of infection. The current study 31,750. We anticipate screening relating to specific AAA activities and
addresses the need to assess the approximately 52,915 individuals communication initiatives.
effectiveness of these social marketing annually to achieve 10,583 respondents
messages aimed at increasing HIV annually. The information collected Survey respondents will be selected
awareness and delivering HIV from each of the data collections were from a combination of sources,
prevention and testing messages among used to evaluate specific AAA campaign including a national opt-in email list
at-risk populations. phases. We are requesting additional sample and respondent lists generated
This extension of an ongoing study time to continue to survey other AAA by partnership organizations (e.g., the
will evaluate the Act Against AIDS target audiences and campaign phases National Urban League, the National
(AAA) social marketing campaign aimed and measuring exposure to each phase Medical Association). Participants will
at increasing HIV/AIDS awareness, of the campaign and interventions self-administer the survey at home on
increasing prevention behaviors, and implemented under AAA. personal computers. There is no cost to
improving HIV testing rates among Depending on the target audience for the respondents other than their time.
consumers. A total of 36,000 the campaign phase, the study screener The total number of estimated annual
respondents were originally approved will vary. The study screener may burden hours is 7,056.
for this 3-year data collection. Since the address one or more of the following
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Respondents Form name responses per
respondents response
respondent (in hours)
Individuals (male and female) aged 18 years Study Screener .............................................. 52,915 1 2/60
and older/Study Screener.
Individuals (male and female) aged 18 years Survey ............................................................ 10,583 1 30/60
and older.
Leroy A. Richardson, comments to Leroy A. Richardson, 1600 maintaining information, and disclosing
Chief, Information Collection Review Office, Clifton Road, MS–D74, Atlanta, GA and providing information; to train
Office of Scientific Integrity, Office of the 30333 or send an email to omb@cdc.gov. personnel and to be able to respond to
Associate Director for Science, Office of the Comments submitted in response to a collection of information, to search
Director, Centers for Disease Control and this notice will be summarized and/or data sources, to complete and review
Prevention. included in the request for Office of the collection of information; and to
[FR Doc. 2015–03246 Filed 2–17–15; 8:45 am] Management and Budget (OMB) transmit or otherwise disclose the
BILLING CODE 4163–18–P approval. Comments are invited on: (a) information. Written comments should
Whether the proposed collection of be received within 60 days of this
information is necessary for the proper notice.
DEPARTMENT OF HEALTH AND performance of the functions of the
HUMAN SERVICES agency, including whether the Proposed Project
information shall have practical utility; Birth Defects Study To Evaluate
Centers for Disease Control and (b) the accuracy of the agency’s estimate Pregnancy exposures (BD–STEPS)
Prevention of the burden of the proposed collection (formerly titled The National Birth
[60Day–15–0010]
of information; (c) ways to enhance the Defects Prevention Study (NBDPS)),
quality, utility, and clarity of the (OMB 0920–0010, Expiration 01/31/
Proposed Data Collections Submitted information to be collected; (d) ways to 2017)—Revision—National Center on
for Public Comment and minimize the burden of the collection of Birth Defects and Developmental
Recommendations information on respondents, including Disabilities (NCBDDD), Centers for
through the use of automated collection Disease Control and Prevention (CDC).
The Centers for Disease Control and techniques or other forms of information
Prevention (CDC), as part of its technology; and (e) estimates of capital Background and Brief Description
continuing effort to reduce public or start-up costs and costs of operation, CDC has been monitoring the
burden and maximize the utility of maintenance, and purchase of services occurrence of serious birth defects and
government information, invites the to provide information. Burden means genetic diseases in Atlanta since 1967
general public and other Federal the total time, effort, or financial through the Metropolitan Atlanta
agencies to take this opportunity to resources expended by persons to Congenital Defects Program (MACDP).
emcdonald on DSK67QTVN1PROD with NOTICES
comment on proposed and/or generate, maintain, retain, disclose or The MACDP is a population-based
continuing information collections, as provide information to or for a Federal surveillance system for birth defects
required by the Paperwork Reduction agency. This includes the time needed currently covering three counties in
Act of 1995. To request more to review instructions; to develop, Metropolitan Atlanta.
information on the below proposed acquire, install and utilize technology Since 1997, CDC has funded case-
project or to obtain a copy of the and systems for the purpose of control studies of major birth defects
information collection plan and collecting, validating and verifying that utilize existing birth defect
instruments, call 404–639–7570 or send information, processing and surveillance registries (including
VerDate Sep<11>2014 19:32 Feb 17, 2015 Jkt 235001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1](https://thefederalregister.org/doc/80_FR_8687/page/1.svg)
![8656 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices
MACDP) to identify cases and study the study will not ask BD–STEPS online questionnaire will be offered to
birth defects causes in participating participants to participate in saliva approximately one third of participants
states/municipalities across the United collection as originally planned, but we who report certain occupations during
States. will add an opportunity for some the telephone interview; these
The current study, BD–STEPS, is a participants to respond to an online participants will be asked to complete
case-control study that is similar to the questionnaire, and we will also ask additional occupational questions via a
previous CDC-funded birth defects case- some participants for permission to Web site which will take approximately
control study, NBDPS, which stopped retrieve newborn bloodspots. 15 minutes to answer.
interviewing participants in 2013. As The BD–STEPS interview takes Information gathered from both the
with NBDPS, BD–STEPS control infants approximately forty-five minutes to interviews and the Deoxyribonucleic
are randomly selected from birth complete. A maximum of 275 acid specimens has been and will
certificates or birth hospital records; interviews are planned per year per continue to be used to study
mothers of case and control infants are center, 200 cases and 75 controls. With independent genetic and environmental
interviewed using a computer-assisted seven centers planned, the maximum factors as well as gene-environment
telephone interview. interview burden for all centers interactions for a broad range of
The results from NBDPS have combined would be approximately
carefully classified birth defects.
improved understanding of the causes 1,444 hours. Mothers in five of the
of birth defects. Over 200 articles have seven BD–STEPS Centers will also be This request is submitted to revise the
been written in professional journals asked to provide consent for the study previously estimated burden details and
using the data from NBDPS, and BD– to access previously collected infant to request OMB clearance for three
STEPS data will soon be added to bloodspots. It takes approximately 15 additional years. The total estimated
NBDPS data for analysis. The current minutes to read, sign and return the annual burden hours are 1,949.
BD–STEPS revision is a change in informed consent for retrieval of There are no costs to the respondents
proposed data collection. Specifically, bloodspots. Finally, the newly planned other than their time.
ESTIMATES OF ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden Total burden
Respondents Activity responses per
respondents per response hours
respondent (In hours)
Mothers (interview) ........................... Telephone consent and BD–STEPS 1,925 1 45/60 1,444
questionnaire.
Mothers (consent for bloodspot re- Written consent for bloodspot re- 1,375 1 15/60 344
trieval). trieval.
Mothers (online occupational ques- Online Occupational Questionnaire 642 1 15/60 161
tionnaire).
TOTAL ....................................... ........................................................... ........................ ........................ ........................ 1,949
Leroy A. Richardson, continuing information collections, as techniques or other forms of information
Chief, Information Collection Review Office, required by the Paperwork Reduction technology; and (e) estimates of capital
Office of Scientific Integrity, Office of the Act of 1995. To request more or start-up costs and costs of operation,
Associate Director for Science, Office of the information on the below proposed maintenance, and purchase of services
Director, Centers for Disease Control and project or to obtain a copy of the
Prevention.
to provide information. Burden means
information collection plan and the total time, effort, or financial
[FR Doc. 2015–03245 Filed 2–17–15; 8:45 am] instruments, call 404–639–7570 or send resources expended by persons to
BILLING CODE 4163–18–P comments to Leroy A. Richardson, 1600 generate, maintain, retain, disclose or
Clifton Road, MS–D74, Atlanta, GA provide information to or for a Federal
30333 or send an email to omb@cdc.gov. agency. This includes the time needed
DEPARTMENT OF HEALTH AND
Comments submitted in response to to review instructions; to develop,
HUMAN SERVICES
this notice will be summarized and/or acquire, install and utilize technology
Centers for Disease Control and included in the request for Office of and systems for the purpose of
Prevention Management and Budget (OMB) collecting, validating and verifying
approval. Comments are invited on: (a) information, processing and
[60Day–15–15NS] Whether the proposed collection of
maintaining information, and disclosing
information is necessary for the proper
Proposed Data Collections Submitted and providing information; to train
performance of the functions of the
for Public Comment and personnel and to be able to respond to
agency, including whether the
Recommendations a collection of information, to search
information shall have practical utility;
data sources, to complete and review
emcdonald on DSK67QTVN1PROD with NOTICES
The Centers for Disease Control and (b) the accuracy of the agency’s estimate
Prevention (CDC), as part of its of the burden of the proposed collection the collection of information; and to
continuing effort to reduce public of information; (c) ways to enhance the transmit or otherwise disclose the
burden and maximize the utility of quality, utility, and clarity of the information. Written comments should
government information, invites the information to be collected; (d) ways to be received within 60 days of this
general public and other Federal minimize the burden of the collection of notice.
agencies to take this opportunity to information on respondents, including
comment on proposed and/or through the use of automated collection
VerDate Sep<11>2014 20:47 Feb 17, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1](https://thefederalregister.org/doc/80_FR_8687/page/2.svg)
Document Created: 2018-02-16 11:10:25
Document Modified: 2018-02-16 11:10:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 8655 |
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