83 FR 28233 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 117 (June 18, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 117 (June 18, 2018)
| Page Range | 28233-28234 | |
| FR Document | 2018-12972 |
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)] [Notices] [Pages 28233-28234] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12972] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-0530] 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 Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) Dose Reconstruction Interviews and Forms 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 February 20, 2018 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) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project EEOICPA Dose Reconstruction Interviews and Forms, OMB No. 0920- 0530, expires 04/30/2018--Reinstatement without change--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description On October 30, 2000, the Energy Employees Occupational Illness [[Page 28234]] Compensation Program Act of 2000 (42 U.S.C. 7384-7385) was enacted. This Act established a federal compensation program for employees of the Department of Energy (DOE) and certain of its contractors, subcontractors and vendors, who have suffered cancers and other designated illnesses as a result of exposures sustained in the production and testing of nuclear weapons. Executive Order 13179, issued on December 7, 2000, delegated authorities assigned to ``the President'' under the Act to the Departments of Labor, Health and Human Services, Energy and Justice. The Department of Health and Human Services (DHHS) was delegated the responsibility of establishing methods for estimating radiation doses received by eligible claimants with cancer applying for compensation. NIOSH is applying the following methods to estimate the radiation doses of individuals applying for compensation. In performance of its dose reconstruction responsibilities, under the Act, NIOSH is providing voluntary interview opportunities to claimants (or their survivors) individually and providing them with the opportunity to assist NIOSH in documenting the work history of the employee by characterizing the actual work tasks performed. In addition, NIOSH and the claimant may identify incidents that may have resulted in undocumented radiation exposures, characterizing radiological protection and monitoring practices, and identify co- workers and other witnesses as may be necessary to confirm undocumented information. In this process, NIOSH uses a computer assisted telephone interview (CATI) system, which allows interviews to be conducted more efficiently and quickly as opposed to a paper-based interview instrument. Both interviews are voluntary and failure to participate in either or both interviews will not have a negative effect on the claim, although voluntary participation may assist the claimant by adding important information that may not be otherwise available. There are no changes to the questions contained in the package, or the estimated burden hours. This Information Collection Request (ICR) is being submitted as a reinstatement because the previous ICR expired on April 30, 2018 and the updated ICR was not submitted before the expiration date. NIOSH uses the data collected in this process to complete an individual dose reconstruction that accounts, as fully as possible, for the radiation dose incurred by the employee in the line of duty for DOE nuclear weapons production programs. After dose reconstruction, NIOSH also performs a brief, voluntary final interview with the claimant to explain the results and to allow the claimant to confirm or question the records NIOSH has compiled. This will also be the final opportunity for the claimant to supplement the dose reconstruction record. At the conclusion of the dose reconstruction process, the claimant submits a form to confirm that the claimant has no further information to provide to NIOSH about the claim at this time. The form notifies the claimant that signing the form allows NIOSH to forward a dose reconstruction report to DOL and to the claimant, and closes the record on data used for the dose reconstruction. Signing this form does not indicate that the claimant agrees with the outcome of the dose reconstruction. The dose reconstruction results will be supplied to the claimant and to the DOL, the agency that will utilize them as one part of its determination of whether the claimant is eligible for compensation under the Act. Total annualized burden is estimated to be 3900 hours. There is no cost to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Claimant........................... Initial Interview.......... 3,600 1 1 Claimant........................... Conclusion form OCAS-1..... 3,600 1 5/60 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, 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. 2018-12972 Filed 6-15-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28233
practice. This study aligns with However, we have discussed the study individuals will need to be screened to
National HIV/AIDS Strategy 2020 and with HRSA/HAB and HHS/OD, and identify and enroll 1,000 eligible study
Healthy People 2020 objectives of plan to apprise CMS and HRSA of the participants. After an HIV testing
reducing new HIV infections, increasing project before implementation and session at an outreach event or clinic
access to care and improving health invite CMS and HRSA representatives to visit, partner agency staff will invite
outcomes for people living with HIV, serve as consultants. HHS may also individuals to participate in the study.
and reducing HIV-related health direct us to the CMS regional officer for If individuals are interested, staff will
disparities. This study also aligns with Chicago, Illinois. Additionally, there is screen individuals for eligibility using
the Office of Management and Budget’s the potential to have CMS grantee the Participant Eligibility Form
emphasis on application of behavioral navigators supplement partner agency (Attachment 5) which will take
insights in that it restructures the navigators during outreach HIV testing approximately 5 minutes to complete. If
context (i.e., after HIV testing) in which events. For this study, CDC is not they are determined eligible to
health-related decision-making (i.e., engaged in research, and therefore not
participate, and still interested in
health insurance enrollment) occurs in involved in data collection activities.
participating, the individual will
order to promote the selection of The grantee is responsible for
beneficial options (i.e., attending HIV- implementing the intervention and complete an Informed Consent Form
related medical care appointments). collecting data from the proposed 1,000 (Attachment 6), which will take
This proposed health insurance participants. Thus, CDC will not need approximately 10 minutes to complete,
enrollment assistance study has the an interagency data-sharing agreement if and the Participant Enrollment Form
potential for widespread health we do consult with HRSA or CMS. (Attachment 7), which will take
improvements for Black and Hispanic The study will enroll 1,000 approximately 35 minutes to complete.
MSM and transgender persons participants over 12 months to reach The total estimated annualized hourly
regardless of their HIV status. adequate power calculations (500 into burden anticipated for this study is 875
At this time, CDC is not partnering the intervention arm, and 500 into the hours. There is no cost to respondents
with other HHS agencies for this study. control arm). Approximately 1,500 other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden
Type of respondent Form name responses per
respondents per response
respondent (in hours)
Study participant ............................................. Participant Eligibility Form (Att 5) .................. 1,500 1 5/60
Study participant ............................................. Informed Consent Form (Att 6) ...................... 1,000 1 10/60
Study participant ............................................. Participant Enrollment Form (Att 7) ............... 1,000 1 35/60
Jeffrey M. Zirger, Submitted for Public Comment and technological collection techniques or
Acting Chief, Information Collection Review Recommendations’’ notice on February other forms of information technology,
Office, Office of Scientific Integrity, Office 20, 2018 to obtain comments from the e.g., permitting electronic submission of
of the Associate Director for Science, Office public and affected agencies. CDC did responses; and
of the Director, Centers for Disease Control not receive comments related to the (e) Assess information collection
and Prevention. previous notice. This notice serves to costs.
[FR Doc. 2018–12971 Filed 6–15–18; 8:45 am] allow an additional 30 days for public To request additional information on
BILLING CODE 4163–18–P and affected agency comments. the proposed project or to obtain a copy
CDC will accept all comments for this of the information collection plan and
proposed information collection project. instruments, call (404) 639–7570 or
DEPARTMENT OF HEALTH AND The Office of Management and Budget send an email to omb@cdc.gov. Direct
HUMAN SERVICES is particularly interested in comments written comments and/or suggestions
that: regarding the items contained in this
Centers for Disease Control and (a) Evaluate whether the proposed notice to the Attention: CDC Desk
Prevention collection of information is necessary Officer, Office of Management and
[30Day–18–0530] for the proper performance of the Budget, 725 17th Street NW,
functions of the agency, including Washington, DC 20503 or by fax to (202)
Agency Forms Undergoing Paperwork whether the information will have 395–5806. Provide written comments
Reduction Act Review practical utility; within 30 days of notice publication.
(b) Evaluate the accuracy of the
In accordance with the Paperwork agencies estimate of the burden of the Proposed Project
Reduction Act of 1995, the Centers for proposed collection of information, EEOICPA Dose Reconstruction
Disease Control and Prevention (CDC) including the validity of the Interviews and Forms, OMB No. 0920–
has submitted the information methodology and assumptions used; 0530, expires 04/30/2018—
collection request titled Energy (c) Enhance the quality, utility, and Reinstatement without change—
amozie on DSK3GDR082PROD with NOTICES1
Employees Occupational Illness clarity of the information to be National Institute for Occupational
Compensation Program Act of 2000 collected; Safety and Health (NIOSH), Centers for
(EEOICPA) Dose Reconstruction (d) Minimize the burden of the Disease Control and Prevention (CDC).
Interviews and Forms to the Office of collection of information on those who
Management and Budget (OMB) for are to respond, including, through the Background and Brief Description
review and approval. CDC previously use of appropriate automated, On October 30, 2000, the Energy
published a ‘‘Proposed Data Collection electronic, mechanical, or other Employees Occupational Illness
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![28234 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
Compensation Program Act of 2000 (42 performed. In addition, NIOSH and the duty for DOE nuclear weapons
U.S.C. 7384–7385) was enacted. This claimant may identify incidents that production programs. After dose
Act established a federal compensation may have resulted in undocumented reconstruction, NIOSH also performs a
program for employees of the radiation exposures, characterizing brief, voluntary final interview with the
Department of Energy (DOE) and certain radiological protection and monitoring claimant to explain the results and to
of its contractors, subcontractors and practices, and identify co-workers and allow the claimant to confirm or
vendors, who have suffered cancers and other witnesses as may be necessary to question the records NIOSH has
other designated illnesses as a result of confirm undocumented information. In compiled. This will also be the final
exposures sustained in the production this process, NIOSH uses a computer opportunity for the claimant to
and testing of nuclear weapons. assisted telephone interview (CATI) supplement the dose reconstruction
Executive Order 13179, issued on system, which allows interviews to be record.
December 7, 2000, delegated authorities conducted more efficiently and quickly At the conclusion of the dose
assigned to ‘‘the President’’ under the as opposed to a paper-based interview reconstruction process, the claimant
Act to the Departments of Labor, Health instrument. Both interviews are submits a form to confirm that the
and Human Services, Energy and voluntary and failure to participate in claimant has no further information to
Justice. The Department of Health and either or both interviews will not have provide to NIOSH about the claim at
Human Services (DHHS) was delegated a negative effect on the claim, although this time. The form notifies the claimant
the responsibility of establishing voluntary participation may assist the that signing the form allows NIOSH to
methods for estimating radiation doses claimant by adding important forward a dose reconstruction report to
received by eligible claimants with information that may not be otherwise DOL and to the claimant, and closes the
cancer applying for compensation. available. record on data used for the dose
NIOSH is applying the following There are no changes to the questions reconstruction. Signing this form does
methods to estimate the radiation doses contained in the package, or the not indicate that the claimant agrees
of individuals applying for estimated burden hours. This with the outcome of the dose
compensation. Information Collection Request (ICR) is reconstruction. The dose reconstruction
In performance of its dose being submitted as a reinstatement results will be supplied to the claimant
reconstruction responsibilities, under because the previous ICR expired on and to the DOL, the agency that will
the Act, NIOSH is providing voluntary April 30, 2018 and the updated ICR was utilize them as one part of its
interview opportunities to claimants (or not submitted before the expiration determination of whether the claimant
their survivors) individually and date. NIOSH uses the data collected in is eligible for compensation under the
providing them with the opportunity to this process to complete an individual Act.
assist NIOSH in documenting the work dose reconstruction that accounts, as Total annualized burden is estimated
history of the employee by fully as possible, for the radiation dose to be 3900 hours. There is no cost to
characterizing the actual work tasks incurred by the employee in the line of respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Type of respondents Form name respondents per response
respondent (in hours)
Claimant .......................................................... Initial Interview ............................................... 3,600 1 1
Claimant .......................................................... Conclusion form OCAS–1 .............................. 3,600 1 5/60
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND Under the Paperwork Reduction Act of
Acting Chief, Information Collection Review HUMAN SERVICES 1995 (PRA), Federal Agencies are
Office, Office of Scientific Integrity, Office required to publish notice in the
of the Associate Director for Science, Office Food and Drug Administration Federal Register concerning each
of the Director, Centers for Disease Control proposed collection of information,
and Prevention. [Docket No. FDA–2013–D–0286] including each proposed extension of an
[FR Doc. 2018–12972 Filed 6–15–18; 8:45 am] existing collection of information, and
Agency Information Collection to allow 60 days for public comment in
BILLING CODE 4163–18–P
Activities; Proposed Collection; response to the notice. This notice
Comment Request; Guidance for solicits comments on formal meetings
Industry: Formal Meetings Between the between FDA and biosimilar biological
Food and Drug Administration and product sponsors or applicants.
Biosimilar Biological Product DATES: Submit either electronic or
Sponsors or Applicants written comments on the collection of
AGENCY: Food and Drug Administration, information by August 17, 2018.
HHS. ADDRESSES: You may submit comments
amozie on DSK3GDR082PROD with NOTICES1
ACTION: Notice. as follows. Please note that late,
untimely filed comments will not be
SUMMARY: The Food and Drug considered. Electronic comments must
Administration (FDA or Agency) is be submitted on or before August 17,
announcing an opportunity for public 2018. The https://www.regulations.gov
comment on the proposed collection of electronic filing system will accept
certain information by the Agency. comments until midnight Eastern Time
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Document Created: 2018-06-18 15:50:27
Document Modified: 2018-06-18 15:50:27
| 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 | 83 FR 28233 |
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