Agency Forms Undergoing Paperwork Reduction Act Review, 44314-44316 [2019-18207]

Download as PDF 44314 Federal Register / Vol. 84, No. 164 / Friday, August 23, 2019 / Notices is used to electronically submit fellowship applications, fellowship host site proposals, and to maintain fellowship alumni directories online. FMS is a flexible and robust electronic information system that is standardized and tailored for each CDC fellowship, collecting only the minimum amount of information needed. Thus, streamlining data management for CDC and reducing the burden for respondents. FMS is key to CDC’s ability to protect the public’s health by supporting training opportunities that strengthen the public health workforce. The proposed Revision will contribute significant enhancements and provide CDC with an efficient, effective, and secure electronic mechanism for collecting, processing, and monitoring fellowship information. The update to the technology platform will make it easier for additional fellowships to choose to use FMS. The increased efficiencies will allow programs to conduct their administrative data collection and monitor fellows’ learning outcomes with a reduced burden and minimal development requirements. The mission of DSEPD is to improve health outcomes through a competent, sustainable, and empowered public health workforce. Professionals in public health, epidemiology, medicine, economics, information science, veterinary medicine, nursing, public policy, and other related professionals seek opportunities, through CDC fellowships, to broaden their knowledge, and skills to improve the science and practice of public health. CDC fellows are assigned to state, tribal, local, and territorial public health agencies; federal government agencies, including CDC and Department of Health and Human Services’ (HHS) operational divisions, such as Centers for Medicare & Medicaid Services; and to nongovernmental organizations, including academic institutions, tribal organizations, and private public health organizations. A three-year revision will allow all fellowship applicants, public health agencies that host fellowship participants, and fellowship alumni the continued use of FMS for submission of electronic data. The annual burden table reflects OMB-approved changes since 2017. There is no cost to respondents other than their time. Total Burden Hours requested are 6361. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Fellowship applicants ........................ Subset of FMS Fellowship Applicants **. Reference Letter Writers ................... Public Health Agency or Organization Staff. Fellowship Alumni ............................. Public Health Agency or Organization Staff. FMS Application Module .................. FMS Application Module .................. 2,216 ** 200 1 1 105/60 30/60 3,878 100 FMS Application Module .................. FMS Activity Tracking Module ......... 4,412 350 1 2 15/60 15/60 1,103 175 FMS Alumni Directory ...................... FMS Host Site Module ..................... 1,732 448 1 1 15/60 90/60 433 672 Total ........................................... ........................................................... ........................ ........................ ........................ 6,361 ** Subset of the total 2216 applicants. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–18210 Filed 8–22–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–19–0010] jbell on DSK3GLQ082PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Birth Defects Study To Evaluate Pregnancy exposureS (BD–STEPS) to the Office of Management and Budget (OMB) for review and approval. CDC previously VerDate Sep<11>2014 16:40 Aug 22, 2019 Jkt 247001 published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on March 4, 2019 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (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; PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 (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 omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) E:\FR\FM\23AUN1.SGM 23AUN1 44315 Federal Register / Vol. 84, No. 164 / Friday, August 23, 2019 / Notices 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Birth Defects Study To Evaluate Pregnancy exposureS (OMB Control No. 0920–0010, Exp. 02/29/2020)— Revision—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, which 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. CDC’s National Center on Birth Defects and Development Disabilities (NCBDDD) works to identify causes of birth defects, improve the health of those living with birth defects, and find and promote opportunities for prevention. For example, vaccination programs have reduced the incidence of congenital rubella syndrome, Rh hemolytic disease of the newborn can be prevented by appropriate medical practice, 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. For most birth defects, however, the causes are not known, making prevention efforts challenging to develop. To improve understanding of the causes of birth defects, CDC initiated active surveillance of birth defects in the wake of the thalidomide tragedy. The system has been in continuous operation since 1967 and is the longest running active surveillance system in the world. Over this period CDC adapted the system to both utilize and contribute to new findings about the epidemiology and causes of birth defects. Previous related efforts include the ‘‘Metropolitan Atlanta Congenital Defects Program’’ (MACDP) and the ‘‘National Birth Defects Prevention Study’’ (NBDPS). In its current form, CDC conducts birth defects surveillance through the Birth Defects Study To Evaluate Pregnancy exposureS (BD–STEPS, OMB No. 0920–0010). BD–STEPS is a CDCfunded collaborative effort involving six CDC-funded, state-based Centers for Birth Defects Research and Prevention (CBDRP) that have legislative authority to collect population-based information on infants with major congenital malformations (Arkansas, California, Iowa, Massachusetts, New York, and North Carolina). CDC serves as an additional site on behalf of Georgia. Information collection for BD–STEPS is based on a case-control design that builds upon information obtained from state-based vital records and birth defects tracking systems. At all CBDRP sites, mothers who have given birth to infants with birth defects are invited to participate in a computer-assisted telephone interview (CATI) to discuss their medical history, pregnancies, environmental exposures, and medications. In addition, interviews are conducted with mothers of controlinfants from each CBDRP, selected randomly from live-born infants without a major birth defect. Controls are identified either from vital records (birth certificates) or from hospitals of birth, and represent the birth population from which the case infants were identified. Two CBDRP sites (Arkansas and Massachusetts) also conduct interviews with mothers of infants who are stillborn without major birth defects, and controls. In states that allow retrieval of blood spots, BD–STEPS participants are asked for permission to share a portion of the newborn blood spot for the child who is part of the study, and for mothers of multiples, the co-siblings of this child. Finally, the interviews identify mothers who work in one of eight occupational categories of interest. These respondents are asked to complete a supplemental online questionnaire designed to assess the impact of the workplace on reproductive outcomes. During the next OMB approval period, CDC plans to implement a number of changes, many reflecting increased emphasis on birth defects with established or suspected association with maternal infection. Five new birth defect case groups will be added. In addition, the maternal interviews will include new questions on infections, travel history, and marijuana use during pregnancy. The new case groups and questions will increase the estimated burden per interview from 45 minutes to 55 minutes. CBDRPs will also begin asking mothers for permission to access information on reportable infectious diseases from their state health departments. The estimated burden per response is 15 minutes. CDC will discontinue plans for a medical records review that was previously approved but never implemented. Additional changes will also affect burden estimates. The estimated number of case interviews per site will increase from 200 to 270, and the number of control interviews per site will increase from 75 to 100. The number of interviews with mothers who gave birth to a stillborn infant will remain constant (220 interviews per site for the two CBDRP sites participating in this information collection activity, plus 100 control interviews per site). The number of respondents who complete the online occupational questionnaire will increase but there is no change to the estimated burden per response of 20 minutes. The number of mothers who are asked to provide permission for bloodspot retrieval will also increase, but the burden per response will not change. CDC will use BD–STEPS data to identify modifiable maternal risk factors and to apply findings to prevention programs for birth defects and stillbirths. Data will also be used to examine hypotheses for geneenvironment interactions involved in the etiology of birth defects. OMB approval is requested for three years. Participation is voluntary and there are no costs to respondents other than their time. The total estimated annualized burden will increase from 3,034 hours to 4,433 hours. jbell on DSK3GLQ082PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name Mothers of birth defects cases and controls .. Telephone Consent Script and BD-STEPS Computer Assisted Telephone Interview. Consent for bloodspot retrieval ...................... Mothers of birth defects cases and controls .. VerDate Sep<11>2014 16:40 Aug 22, 2019 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\23AUN1.SGM Number of responses per respondent Average burden per response (in hours) 3,030 1 55/60 1,850 1 15/60 23AUN1 44316 Federal Register / Vol. 84, No. 164 / Friday, August 23, 2019 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Form name Mothers of birth defects cases and controls .. Mothers of birth defects cases and controls .. Mothers of stillbirths and controls ................... Online Occupational Questionnaire ............... Infectious Disease Request Form .................. Telephone consent and supplemental interview. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–18207 Filed 8–22–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–367a–d] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by October 22, 2019. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and SUMMARY: jbell on DSK3GLQ082PROD with NOTICES Number of respondents Type of respondent VerDate Sep<11>2014 16:40 Aug 22, 2019 Jkt 247001 recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ website address at website address at https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–367a–d Medicaid Drug Program Under the 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. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 Number of responses per respondent 830 2,590 640 Average burden per response (in hours) 1 1 1 20/60 15/60 25/60 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Program; Use: Labelers transmit drug product and pricing data to CMS within 30 days after the end of each calendar month and quarter. CMS calculates the unit rebate amount (URA) and the unit rebate offset amount (UROA) for each new drug application (NDC) and distributes to all State Medicaid agencies. States use the URA to invoice the labeler for rebates and the UROA to report onto the CMS–64. The monthly data is used to calculate Federal Upper Limit (FUL) prices for applicable drugs and for states that opt to use this data to establish their pharmacy reimbursement methodology. Form Number: CMS–367 (OMB control number: 0938–0578); Frequency: Monthly, quarterly, and on occasion; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 743; Total Annual Responses: 14,117; Total Annual Hours: 219,185. (For policy questions regarding this collection contact Andrea Wellington at 410–786–3490.) Dated: August 20, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–18214 Filed 8–22–19; 8:45 am] BILLING CODE 4120–01–P E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44314-44316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18207]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-0010]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Birth Defects Study To Evaluate Pregnancy 
exposureS (BD-STEPS) to the Office of Management and Budget (OMB) for 
review and approval. CDC previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
March 4, 2019 to obtain comments from the public and affected agencies. 
CDC did not receive comments related to the previous notice. This 
notice serves to allow an additional 30 days for public and affected 
agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202)

[[Page 44315]]

395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Birth Defects Study To Evaluate Pregnancy exposureS (OMB Control 
No. 0920-0010, Exp. 02/29/2020)--Revision--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, which 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.
    CDC's National Center on Birth Defects and Development Disabilities 
(NCBDDD) works to identify causes of birth defects, improve the health 
of those living with birth defects, and find and promote opportunities 
for prevention. For example, vaccination programs have reduced the 
incidence of congenital rubella syndrome, Rh hemolytic disease of the 
newborn can be prevented by appropriate medical practice, 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.
    For most birth defects, however, the causes are not known, making 
prevention efforts challenging to develop. To improve understanding of 
the causes of birth defects, CDC initiated active surveillance of birth 
defects in the wake of the thalidomide tragedy. The system has been in 
continuous operation since 1967 and is the longest running active 
surveillance system in the world. Over this period CDC adapted the 
system to both utilize and contribute to new findings about the 
epidemiology and causes of birth defects. Previous related efforts 
include the ``Metropolitan Atlanta Congenital Defects Program'' (MACDP) 
and the ``National Birth Defects Prevention Study'' (NBDPS).
    In its current form, CDC conducts birth defects surveillance 
through the Birth Defects Study To Evaluate Pregnancy exposureS (BD-
STEPS, OMB No. 0920-0010). BD-STEPS is a CDC-funded collaborative 
effort involving six CDC-funded, state-based Centers for Birth Defects 
Research and Prevention (CBDRP) that have legislative authority to 
collect population-based information on infants with major congenital 
malformations (Arkansas, California, Iowa, Massachusetts, New York, and 
North Carolina). CDC serves as an additional site on behalf of Georgia. 
Information collection for BD-STEPS is based on a case-control design 
that builds upon information obtained from state-based vital records 
and birth defects tracking systems. At all CBDRP sites, mothers who 
have given birth to infants with birth defects are invited to 
participate in a computer-assisted telephone interview (CATI) to 
discuss their medical history, pregnancies, environmental exposures, 
and medications. In addition, interviews are conducted with mothers of 
control-infants from each CBDRP, selected randomly from live-born 
infants without a major birth defect. Controls are identified either 
from vital records (birth certificates) or from hospitals of birth, and 
represent the birth population from which the case infants were 
identified. Two CBDRP sites (Arkansas and Massachusetts) also conduct 
interviews with mothers of infants who are stillborn without major 
birth defects, and controls. In states that allow retrieval of blood 
spots, BD-STEPS participants are asked for permission to share a 
portion of the newborn blood spot for the child who is part of the 
study, and for mothers of multiples, the co-siblings of this child. 
Finally, the interviews identify mothers who work in one of eight 
occupational categories of interest. These respondents are asked to 
complete a supplemental online questionnaire designed to assess the 
impact of the workplace on reproductive outcomes.
    During the next OMB approval period, CDC plans to implement a 
number of changes, many reflecting increased emphasis on birth defects 
with established or suspected association with maternal infection. Five 
new birth defect case groups will be added. In addition, the maternal 
interviews will include new questions on infections, travel history, 
and marijuana use during pregnancy. The new case groups and questions 
will increase the estimated burden per interview from 45 minutes to 55 
minutes. CBDRPs will also begin asking mothers for permission to access 
information on reportable infectious diseases from their state health 
departments. The estimated burden per response is 15 minutes. CDC will 
discontinue plans for a medical records review that was previously 
approved but never implemented.
    Additional changes will also affect burden estimates. The estimated 
number of case interviews per site will increase from 200 to 270, and 
the number of control interviews per site will increase from 75 to 100. 
The number of interviews with mothers who gave birth to a stillborn 
infant will remain constant (220 interviews per site for the two CBDRP 
sites participating in this information collection activity, plus 100 
control interviews per site). The number of respondents who complete 
the online occupational questionnaire will increase but there is no 
change to the estimated burden per response of 20 minutes. The number 
of mothers who are asked to provide permission for bloodspot retrieval 
will also increase, but the burden per response will not change.
    CDC will use BD-STEPS data to identify modifiable maternal risk 
factors and to apply findings to prevention programs for birth defects 
and stillbirths. Data will also be used to examine hypotheses for gene-
environment interactions involved in the etiology of birth defects.
    OMB approval is requested for three years. Participation is 
voluntary and there are no costs to respondents other than their time. 
The total estimated annualized burden will increase from 3,034 hours to 
4,433 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Mothers of birth defects cases and      Telephone Consent Script           3,030               1           55/60
 controls.                               and BD-STEPS Computer
                                         Assisted Telephone
                                         Interview.
Mothers of birth defects cases and      Consent for bloodspot              1,850               1           15/60
 controls.                               retrieval.

[[Page 44316]]

 
Mothers of birth defects cases and      Online Occupational                  830               1           20/60
 controls.                               Questionnaire.
Mothers of birth defects cases and      Infectious Disease                 2,590               1           15/60
 controls.                               Request Form.
Mothers of stillbirths and controls...  Telephone consent and                640               1           25/60
                                         supplemental interview.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-18207 Filed 8-22-19; 8:45 am]
 BILLING CODE 4163-18-P
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