81_FR_18692 81 FR 18630 - Proposed Data Collection Submitted for Public Comment and Recommendations

81 FR 18630 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 62 (March 31, 2016)

Page Range18630-18631
FR Document2016-07226

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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. This notice invites comment on a newly proposed information collection project entitled ``Practice Patterns Related to Opioid Use During Pregnancy and Lactation''. CDC seeks to collect data for the purpose of assessing obstetrician-gynecologists' knowledge, attitudes, and practices regarding screening for and treatment of maternal opioid use surrounding the time of pregnancy. CDC will need a one-year clearance from the Office of Management and Budget (OMB) to collect the necessary data.

Federal Register, Volume 81 Issue 62 (Thursday, March 31, 2016) 
[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Pages 18630-18631]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-16-16XD; Docket No. CDC-2016-0034]


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 efforts 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. This notice invites comment on a newly proposed 
information collection project entitled ``Practice Patterns Related to 
Opioid Use During Pregnancy and Lactation''. CDC seeks to collect data 
for the purpose of assessing obstetrician-gynecologists' knowledge, 
attitudes, and practices regarding screening for and treatment of 
maternal opioid use surrounding the time of pregnancy. CDC will need a 
one-year clearance from the Office of Management and Budget (OMB) to 
collect the necessary data.

DATES: Written comments must be received on or before May 31, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0034 by any of the following methods:
    Federal eRulemaking Portal: Regulation.gov. Follow the instructions 
for submitting comments.
    Mail: Leroy A. Richardson, Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted 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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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.

Proposed Project

    Practice Patterns Related to Opioid Use During Pregnancy and 
Lactation--New--National Center for Chronic Disease Prevention and 
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Over the past decade, the prevalence of maternal opioid use during 
pregnancy has steadily increased. The use of opioids or other 
psychoactive substances, either by illicit abuse or by nonmedical abuse 
of prescription opioids, increases the risks for health and social 
problems for both mother and infant. For example, maternal substance 
abuse during pregnancy increases the risk of preterm birth, low birth 
weight, perinatal death, and neonatal abstinence syndrome (NAS). For 
many women, and some at-risk women in particular, prenatal visits may 
be the only time they routinely see a physician. Because obstetrician-
gynecologists (OB/GYNs) are the principal health care providers for 
women, OB/GYNs are well situated to screen for substance use and to 
treat or encourage cessation of substance use during pregnancy. Thus, 
it is important to understand current provider knowledge, attitudes, 
and practices regarding maternal opioid use.
    CDC, in collaboration with the American College of Obstetricians 
and Gynecologists (ACOG), plans to conduct a survey to address this gap 
in knowledge. Survey respondents will be ACOG Fellows and Junior 
Fellows who have a current medical license and are in medical practice 
focused on women's health. ACOG is separated into 11 districts, one of 
which represents OB/GYN members who are in the U.S. military. The 
remaining 10 ACOG districts correspond to geographic regions that 
encompass the entire United States and Canada. Survey invitations will 
be sent to a quasi-random sample of ACOG members in each district.
    CDC and ACOG estimate that 1,500 individuals will be contacted in 
order to obtain a study target of 600 respondents. The initial 
invitation will be distributed by email with instructions on completing 
a web-based version of the questionnaire. Three to four months after 
the initial invitation, a paper version of the questionnaire will be

[[Page 18631]]

distributed to individuals who have not completed the online version. 
The estimated number of respondents for the full web-based or paper 
questionnaire is 420 and the estimated burden per response is 15 
minutes. Approximately six weeks after the second recruitment attempt, 
ACOG will distribute a short version of the questionnaire to any non-
responders. The estimated number of responses for the short version of 
the questionnaire is 180 and the estimated burden per response is 5 
minutes. An overall 40% response rate is expected.
    The survey will collect information about provider attitudes and 
beliefs regarding maternal opioid use, their screening and referral 
practices for pregnant or postpartum patients, barriers to screening 
and treating pregnant and postpartum patients for opioid use, and 
resources that are needed to improve treatment and referral.
    No information will be collected about individual patients. Survey 
administration and data management will be conducted by ACOG, and 
participation is voluntary. De-identified response data will be shared 
with CDC for analysis.
    Findings will be used to create recommendations for educational 
programs and patient care. There are no costs to participants other 
than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response (in     (in hours)
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
OB/GYNs caring for pregnant women..............  Practice Patterns Related to Opioid Use             420               1           15/60             105
                                                  During Pregnancy and Lactation.
                                                 Practice Patterns Related to Opioid Use             180               1            5/60              15
                                                  During Pregnancy and Lactation (short
                                                  version).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             120
--------------------------------------------------------------------------------------------------------------------------------------------------------


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. 2016-07226 Filed 3-30-16; 8:45 am]
BILLING CODE 4163-18-P

18630 Federal Register / Vol. 81, No. 62 / Thursday, March 31, 2016 / Notices Dated: March 24, 2016. personal information provided. For and providing information; to train John Hofmann, access to the docket to read background personnel and to be able to respond to Division Director, Facilities Management & documents or comments received, go to a collection of information, to search Services Programs Division, General Services Regulations.gov. data sources, to complete and review Administration, Mid-Atlantic Region. Please note: All public comment should be the collection of information; and to [FR Doc. 2016–07161 Filed 3–30–16; 8:45 am] submitted through the Federal eRulemaking transmit or otherwise disclose the BILLING CODE 6820–89–P portal (Regulations.gov) or by U.S. mail to the information. address listed above. Proposed Project FOR FURTHER INFORMATION CONTACT: To Practice Patterns Related to Opioid DEPARTMENT OF HEALTH AND request more information on the Use During Pregnancy and Lactation— HUMAN SERVICES proposed project or to obtain a copy of New—National Center for Chronic the information collection plan and Disease Prevention and Health Centers for Disease Control and instruments, contact the Information Prevention Promotion (NCCDPHP), Centers for Collection Review Office, Centers for Disease Control and Prevention (CDC). [60 Day–16–16XD; Docket No. CDC–2016– Disease Control and Prevention, 1600 0034] Clifton Road NE., MS–D74, Atlanta, Background and Brief Description Georgia 30329; phone: 404–639–7570; Over the past decade, the prevalence Proposed Data Collection Submitted Email: omb@cdc.gov. of maternal opioid use during for Public Comment and SUPPLEMENTARY INFORMATION: Under the pregnancy has steadily increased. The Recommendations Paperwork Reduction Act of 1995 (PRA) use of opioids or other psychoactive (44 U.S.C. 3501–3520), Federal agencies substances, either by illicit abuse or by AGENCY: Centers for Disease Control and must obtain approval from the Office of nonmedical abuse of prescription Prevention (CDC), Department of Health Management and Budget (OMB) for each opioids, increases the risks for health and Human Services (HHS). collection of information they conduct and social problems for both mother and ACTION: Notice with comment period. or sponsor. In addition, the PRA also infant. For example, maternal substance SUMMARY: The Centers for Disease requires Federal agencies to provide a abuse during pregnancy increases the Control and Prevention (CDC), as part of 60-day notice in the Federal Register risk of preterm birth, low birth weight, its continuing efforts to reduce public concerning each proposed collection of perinatal death, and neonatal abstinence information, including each new syndrome (NAS). For many women, and burden and maximize the utility of proposed collection, each proposed some at-risk women in particular, government information, invites the extension of existing collection of prenatal visits may be the only time general public and other Federal information, and each reinstatement of they routinely see a physician. Because agencies to take this opportunity to previously approved information obstetrician-gynecologists (OB/GYNs) comment on proposed and/or collection before submitting the are the principal health care providers continuing information collections, as collection to OMB for approval. To for women, OB/GYNs are well situated required by the Paperwork Reduction comply with this requirement, we are to screen for substance use and to treat Act of 1995. This notice invites publishing this notice of a proposed or encourage cessation of substance use comment on a newly proposed data collection as described below. during pregnancy. Thus, it is important information collection project entitled Comments are invited on: (a) Whether ‘‘Practice Patterns Related to Opioid Use to understand current provider the proposed collection of information knowledge, attitudes, and practices During Pregnancy and Lactation’’. CDC is necessary for the proper performance seeks to collect data for the purpose of regarding maternal opioid use. of the functions of the agency, including CDC, in collaboration with the assessing obstetrician-gynecologists’ whether the information shall have American College of Obstetricians and knowledge, attitudes, and practices practical utility; (b) the accuracy of the Gynecologists (ACOG), plans to conduct regarding screening for and treatment of agency’s estimate of the burden of the a survey to address this gap in maternal opioid use surrounding the proposed collection of information; (c) knowledge. Survey respondents will be time of pregnancy. CDC will need a one- ways to enhance the quality, utility, and ACOG Fellows and Junior Fellows who year clearance from the Office of clarity of the information to be have a current medical license and are Management and Budget (OMB) to collected; (d) ways to minimize the in medical practice focused on women’s collect the necessary data. burden of the collection of information health. ACOG is separated into 11 DATES: Written comments must be on respondents, including through the districts, one of which represents OB/ received on or before May 31, 2016. use of automated collection techniques GYN members who are in the U.S. ADDRESSES: You may submit comments, or other forms of information military. The remaining 10 ACOG identified by Docket No. CDC–2016– technology; and (e) estimates of capital districts correspond to geographic 0034 by any of the following methods: or start-up costs and costs of operation, regions that encompass the entire Federal eRulemaking Portal: maintenance, and purchase of services United States and Canada. Survey Regulation.gov. Follow the instructions to provide information. Burden means invitations will be sent to a quasi- for submitting comments. the total time, effort, or financial random sample of ACOG members in Mail: Leroy A. Richardson, resources expended by persons to each district. Information Collection Review Office, generate, maintain, retain, disclose or CDC and ACOG estimate that 1,500 mstockstill on DSK4VPTVN1PROD with NOTICES Centers for Disease Control and provide information to or for a Federal individuals will be contacted in order to Prevention, 1600 Clifton Road NE., MS– agency. This includes the time needed obtain a study target of 600 respondents. D74, Atlanta, Georgia 30329. to review instructions; to develop, The initial invitation will be distributed Instructions: All submissions received acquire, install and utilize technology by email with instructions on must include the agency name and and systems for the purpose of completing a web-based version of the Docket Number. All relevant comments collecting, validating and verifying questionnaire. Three to four months received will be posted without change information, processing and after the initial invitation, a paper to Regulations.gov, including any maintaining information, and disclosing version of the questionnaire will be VerDate Sep<11>2014 19:09 Mar 30, 2016 Jkt 238001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1

Federal Register / Vol. 81, No. 62 / Thursday, March 31, 2016 / Notices 18631 distributed to individuals who have not burden per response is 5 minutes. An No information will be collected completed the online version. The overall 40% response rate is expected. about individual patients. Survey estimated number of respondents for the The survey will collect information administration and data management full web-based or paper questionnaire is about provider attitudes and beliefs will be conducted by ACOG, and 420 and the estimated burden per regarding maternal opioid use, their participation is voluntary. De-identified response is 15 minutes. Approximately screening and referral practices for response data will be shared with CDC six weeks after the second recruitment pregnant or postpartum patients, for analysis. attempt, ACOG will distribute a short barriers to screening and treating Findings will be used to create version of the questionnaire to any non- pregnant and postpartum patients for recommendations for educational responders. The estimated number of opioid use, and resources that are programs and patient care. There are no responses for the short version of the needed to improve treatment and costs to participants other than their questionnaire is 180 and the estimated referral. time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) respondent (in hours) OB/GYNs caring for Practice Patterns Related to Opioid Use During 420 1 15/60 105 pregnant women. Pregnancy and Lactation. Practice Patterns Related to Opioid Use During 180 1 5/60 15 Pregnancy and Lactation (short version). Total ........................ .............................................................................. ........................ ........................ ........................ 120 Leroy A. Richardson, burden of the proposed collection of project assigned OMB Control Number Chief, Information Collection Review Office, information, including the validity of 0920–1074, formerly entitled ‘‘Annual Office of Scientific Integrity, Office of the the methodology and assumptions used; Survey of Colorectal Cancer Control Associate Director for Science, Office of the (c) Enhance the quality, utility, and Activities Conducted by States and Director, Centers for Disease Control and clarity of the information to be Tribal Organizations.’’ In the previous Prevention. collected; (d) Minimize the burden of OMB approval period, information [FR Doc. 2016–07226 Filed 3–30–16; 8:45 am] the collection of information on those collection consisted of an annual BILLING CODE 4163–18–P who are to respond, including through grantee survey. In the next OMB the use of appropriate automated, approval period, information collection electronic, mechanical, or other will consist of a redesigned survey and DEPARTMENT OF HEALTH AND technological collection techniques or a new clinic-level information HUMAN SERVICES other forms of information technology, collection. The number of respondents e.g., permitting electronic submission of will increase and the total estimated Centers for Disease Control and responses; and (e) Assess information annualized burden will increase. Prevention collection costs. Among cancers that affect both men To request additional information on and women, colorectal cancer (CRC) is [30 Day–16–1074] the proposed project or to obtain a copy the second leading cause of death from Agency Forms Undergoing Paperwork of the information collection plan and cancer in the United States. CRC Reduction Act Review instruments, call (404) 639–7570 or screening has been shown to reduce send an email to omb@cdc.gov. Written incidence of and death from the disease. The Centers for Disease Control and comments and/or suggestions regarding Screening for CRC can detect disease Prevention (CDC) has submitted the the items contained in this notice early when treatment is more effective following information collection request should be directed to the Attention: and prevent cancer by finding and to the Office of Management and Budget CDC Desk Officer, Office of Management removing precancerous polyps. Of (OMB) for review and approval in and Budget, Washington, DC 20503 or individuals diagnosed with early stage accordance with the Paperwork by fax to (202) 395–5806. Written CRC, more than 90% live five or more Reduction Act of 1995. The notice for comments should be received within 30 years. Despite strong evidence the proposed information collection is days of this notice. supporting screening, only 65% of published to obtain comments from the adults currently report being up-to-date Proposed Project public and affected agencies. with CRC screening as recommended by Written comments and suggestions Colorectal Cancer Control Program the U.S. Preventive Services Task Force, from the public and affected agencies (CRCCP) Monitoring Activities with more than 22 million age-eligible concerning the proposed collection of —Reinstatement with Change (OMB No. adults estimated to be untested. To information are encouraged. Your 0920–1074, exp. 12/31/2015) reduce CRC morbidity, mortality, and mstockstill on DSK4VPTVN1PROD with NOTICES comments should address any of the —National Center for Chronic Disease associated costs, use of CRC screening following: (a) Evaluate whether the Prevention and Health Promotion tests must be increased among age- proposed collection of information is (NCCDPHP), Centers for Disease eligible adults with the lowest CRC necessary for the proper performance of Control and Prevention (CDC). screening rates. the functions of the agency, including CDC’s Colorectal Cancer Control whether the information will have Background and Brief Description Program (CRCCP) currently provides practical utility; (b) Evaluate the CDC is requesting a reinstatement funding to 31 grantees under accuracy of the agencies estimate of the with change of the information collect ‘‘Organized Approaches to Increase VerDate Sep<11>2014 19:09 Mar 30, 2016 Jkt 238001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1


Document Created: 2016-03-31 00:56:06
Document Modified: 2016-03-31 00:56:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before May 31, 2016.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation81 FR 18630 
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