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)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52436-52438 | |
| FR Document | 2016-18746 |
[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] ----------------------------------------------------------------------- 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 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, 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. ---------------------------------------------------------------------------------------------------------------- [[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
![52436 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Avg. burden
Number of
Type of respondents Form name responses per per response
respondents respondent (in hrs.)
Medical/Clinical Laboratory Technologist ....... 57.307 Hemovigilance Adverse Reaction— 500 4 25/60
Acute Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.308 Hemovigilance Adverse Reaction— 500 4 25/60
Allergic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.309 Hemovigilance Adverse Reaction— 500 1 25/60
Delayed Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.310 Hemovigilance Adverse Reaction— 500 2 25/60
Delayed Serologic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.311 Hemovigilance Adverse Reaction— 500 4 25/60
Febrile Non-hemolytic Transfusion Reac-
tion.
Medical/Clinical Laboratory Technologist ....... 57.312 Hemovigilance Adverse Reaction— 500 1 25/60
Hypotensive Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.313 Hemovigilance Adverse Reaction— 500 1 25/60
Infection.
Medical/Clinical Laboratory Technologist ....... 57.314 Hemovigilance Adverse Reaction— 500 1 25/60
Post Transfusion Purpura.
Medical/Clinical Laboratory Technologist ....... 57.315 Hemovigilance Adverse Reaction— 500 1 25/60
Transfusion Associated Dyspnea.
Medical/Clinical Laboratory Technologist ....... 57.316 Hemovigilance Adverse Reaction— 500 1 25/60
Transfusion Associated Graft vs. Host Dis-
ease.
Medical/Clinical Laboratory Technologist ....... 57.317 Hemovigilance Adverse Reaction— 500 1 25/60
Transfusion Related Acute Lung Injury.
Medical/Clinical Laboratory Technologist ....... 57.318 Hemovigilance Adverse Reaction— 500 2 25/60
Transfusion Associated Circulatory Over-
load.
Medical/Clinical Laboratory Technologist ....... 57.319 Hemovigilance Adverse Reaction— 500 1 25/60
Unknown Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.320 Hemovigilance Adverse Reaction— 500 1 25/60
Other Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.400 Patient Safety Component—Annual 5,000 1 5/60
Facility Survey for Ambulatory Surgery
Center (ASC).
Staff RN .......................................................... 57.401 Outpatient Procedure Component— 5,000 12 15/60
Monthly Reporting Plan.
Staff RN .......................................................... 57.402 Outpatient Procedure Component 5,000 25 40/60
Event.
Staff RN .......................................................... 57.403 Outpatient Procedure Component— 5,000 12 40/60
Monthly Denominators and Summary.
Staff RN .......................................................... 57.500 Outpatient Dialysis Center Practices 6,500 1 2.0
Survey.
Registered Nurse (Infection Preventionist) ..... 57.501 Dialysis Monthly Reporting Plan ........ 6,500 12 5/60
Staff RN .......................................................... 57.502 Dialysis Event .................................... 6,500 60 25/60
Staff RN .......................................................... 57.503 Denominator for Outpatient Dialysis .. 6,500 12 10/60
Staff RN .......................................................... 57.504 Prevention Process Measures Month- 1,500 12 1.25
ly Monitoring for Dialysis.
Staff RN .......................................................... 57.505 Dialysis Patient Influenza Vaccination 325 75 10/60
Staff RN .......................................................... 57.506 Dialysis Patient Influenza Vaccination 325 5 10/60
Denominator.
Staff RN .......................................................... 57.507 Home Dialysis Center Practices Sur- 600 1 25/60
vey.
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND to the Office of Management and Budget
Health Scientist, Acting Chief, Information HUMAN SERVICES (OMB) for review and approval in
Collection Review Office, Office of Scientific accordance with the Paperwork
Integrity, Office of the Associate Director for Centers for Disease Control and Reduction Act of 1995. The notice for
Science, Office of the Director, Centers for Prevention the proposed information collection is
Disease Control and Prevention. published to obtain comments from the
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–18710 Filed 8–5–16; 8:45 am] [30Day–16–0010] public and affected agencies.
BILLING CODE 4163–18–P
Agency Forms Undergoing Paperwork Written comments and suggestions
Reduction Act Review from the public and affected agencies
concerning the proposed collection of
The Centers for Disease Control and information are encouraged. Your
Prevention (CDC) has submitted the comments should address any of the
following information collection request following: (a) Evaluate whether the
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![52438 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
Jeffrey M. Zirger, the following proposed collection of with 52 state Ombudsman programs
Health Scientist, Acting Chief, Information information to the Office of responding annually.
Collection Review Office, Office of Scientific Management and Budget (OMB) for Dated: August 2, 2016.
Integrity, Office of the Associate Director for review and clearance. The
Science, Office of the Director, Centers for Edwin L. Walker,
Administration for Community Living/
Disease Control and Prevention. Acting Assistant Secretary for Aging.
Administration on Aging (ACL/AoA) is
[FR Doc. 2016–18746 Filed 8–5–16; 8:45 am] [FR Doc. 2016–18736 Filed 8–5–16; 8:45 am]
requesting approval from the Office of
BILLING CODE 4163–18–P Management and Budget (OMB) for data BILLING CODE 4154–01–P
collection associated with the National
Ombudsman Reporting System (NORS).
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
The report form and instructions have
HUMAN SERVICES HUMAN SERVICES
been in continuous use, with minor
Administration for Community Living, modifications, since they were first Administration for Community Living
Administration on Aging approved by OMB for the FY 1995
reporting period. This request is for Agency Information Collection
Agency Information Collection approval to revise the data collection Activities: Submission for OMB
Activities; Proposed Collection; tool to enhance ACL’s ability to Review; Comment Request; the
Comment Request; State Annual Long- understand and report on: LTCO National Maltreatment Reporting
Term Care Ombudsman Report program operations, experience of long- System
Revised Data Collection to the National term care facility residents and to
update to reflect changes in: LTC AGENCY: Administration for Community
Ombudsman Reporting System
Ombudsman program operations and Living, HHS
AGENCY: Administration for Community long-term supports and services ACTION: Notice
Living, Administration on Aging, HHS. policies, research, and practices. States
ACTION: Notice. SUMMARY: The Administration for
will continue to provide the following
Community Living (formerly the
data and narrative information in the
SUMMARY: The Administration on Administration on Aging (AoA) is
report:
Community Living, Administration on announcing that the proposed collection
1. Numbers and descriptions of cases
Aging (ACL/AoA) is announcing an of information listed below has been
filed and complaints made on behalf of
opportunity for public comment on the submitted to the Office of Management
long-term care facility residents to the
proposed collection of certain and Budget (OMB) for review and
statewide ombudsman program;
information by the agency. Under the clearance under the Paperwork
2. Major issues identified impacting
Paperwork Reduction Act of 1995 (the Reduction Act of 1995. The purpose of
on the quality of care and life of long-
PRA), Federal agencies are required to this notice is to allow for an additional
term care facility residents;
publish notice in the Federal Register 30 days of public comment on the
3. Statewide program operations; and
concerning each proposed collection of information collection requirements
information, including each proposed 4. Ombudsman activities in addition relating to the National Adult
extension of an existing collection of to complaint investigation. Maltreatment Reporting System
information, and to allow 60 days for 5. Organizational conflict of interest (NAMRS). The proposed collection of
public comment in response to the reporting as required by 45 CFR part information tools may be found in the
notice. This notice solicits comments on 1324.21. NAMRS section of the ACL Web site.
the information collection requirements With respect to the following
DATES: Submit written comments on the
relating to the National Ombudsman collection of information, ACL/AoA
invites comments on: (1) Whether the collection of information by September
Reporting System per 45 CFR part 7, 2016.
1324.21 and Older Americans Act Title proposed collection of information is
necessary for the proper performance of ADDRESSES: Submit written comments
VII. on the collection of information to the
ACL/AoA’s functions, including
DATES: Submit written or electronic Office of Management and Budget,
whether the information will have
comments on the collection of Office for Information and Regulatory
practical utility; (2) the accuracy of
information by October 7, 2016. Affairs, Attention: Desk Officer for ACL
ACL/AoA’s estimate of the burden of
ADDRESSES: Submit electronic the proposed collection of information, by email: OIRA_submission@
comments on the collection of including the validity of the omb.eop.gov or fax: 202.395.6974.
information to: louise.ryan@acl.hhs.gov. methodology and assumptions used; (3) FOR FURTHER INFORMATION CONTACT:
Submit written comments on the ways to enhance the quality, utility, and Stephanie Whittier Eliason,
collection of information to: U.S. clarity of the information to be Administration for Community Living,
Department of Health and Human collected; and (4) ways to minimize the 330 C St. SW., Washington, DC 20201;
Services: Administration for burden of the collection of information email: stephanie.whittiereliason@
Community Living 701 Fifth Avenue, on respondents, including through the acl.hhs.gov; telephone: 202.795.7467.
Suite 1600 M/S RX–33, Seattle, WA use of automated collection techniques Copies of available documents
98104, Attention: Louise Ryan. when appropriate, and other forms of submitted to OMB may be obtained by
FOR FURTHER INFORMATION CONTACT: information technology. contacting Stephanie Whittier Eliason.
Louise Ryan by telephone: (206) 615– The proposed data collection tools SUPPLEMENTARY INFORMATION: In
mstockstill on DSK3G9T082PROD with NOTICES
2514 or by email: louise.ryan@ may be found on the ACL/AoA Web site compliance with PRA (44 U.S.C. 3501–
acl.hhs.gov. at: http://www.aoa.acl.gov/AoA_ 3520), the Administration for
SUPPLEMENTARY INFORMATION: In Programs/Elder_Rights/Ombudsman/ Community Living (ACL, formerly the
compliance with PRA (44 U.S.C. 3501– index.aspx. Administration for Aging) has submitted
3520), the Administration for AoA estimates the burden of this the following proposed collection of
Community Living (ACL, formerly the additional collection of information as information to the Office of
Administration for Aging) has submitted follows: Approximately 7780 hours, Management and Budget (OMB) for
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Document Created: 2016-08-06 03:08:39
Document Modified: 2016-08-06 03:08:39
| 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 | 81 FR 52436 |
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