Agency Forms Undergoing Paperwork Reduction Act Review, 28233-28234 [2018-12972]

Download as PDF 28233 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices practice. This study aligns with National HIV/AIDS Strategy 2020 and Healthy People 2020 objectives of reducing new HIV infections, increasing access to care and improving health outcomes for people living with HIV, and reducing HIV-related health disparities. This study also aligns with the Office of Management and Budget’s emphasis on application of behavioral insights in that it restructures the context (i.e., after HIV testing) in which health-related decision-making (i.e., health insurance enrollment) occurs in order to promote the selection of beneficial options (i.e., attending HIVrelated medical care appointments). This proposed health insurance enrollment assistance study has the potential for widespread health improvements for Black and Hispanic MSM and transgender persons regardless of their HIV status. At this time, CDC is not partnering with other HHS agencies for this study. However, we have discussed the study with HRSA/HAB and HHS/OD, and plan to apprise CMS and HRSA of the project before implementation and invite CMS and HRSA representatives to serve as consultants. HHS may also direct us to the CMS regional officer for Chicago, Illinois. Additionally, there is the potential to have CMS grantee navigators supplement partner agency navigators during outreach HIV testing events. For this study, CDC is not engaged in research, and therefore not involved in data collection activities. The grantee is responsible for implementing the intervention and collecting data from the proposed 1,000 participants. Thus, CDC will not need an interagency data-sharing agreement if we do consult with HRSA or CMS. The study will enroll 1,000 participants over 12 months to reach adequate power calculations (500 into the intervention arm, and 500 into the control arm). Approximately 1,500 individuals will need to be screened to identify and enroll 1,000 eligible study participants. After an HIV testing session at an outreach event or clinic visit, partner agency staff will invite individuals to participate in the study. If individuals are interested, staff will screen individuals for eligibility using the Participant Eligibility Form (Attachment 5) which will take approximately 5 minutes to complete. If they are determined eligible to participate, and still interested in participating, the individual will complete an Informed Consent Form (Attachment 6), which will take approximately 10 minutes to complete, and the Participant Enrollment Form (Attachment 7), which will take approximately 35 minutes to complete. The total estimated annualized hourly burden anticipated for this study is 875 hours. There is no cost to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name Study participant ............................................. Study participant ............................................. Study participant ............................................. Participant Eligibility Form (Att 5) .................. Informed Consent Form (Att 6) ...................... Participant Enrollment Form (Att 7) ............... 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. 2018–12971 Filed 6–15–18; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–18–0530] amozie on DSK3GDR082PROD with NOTICES1 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 VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 1,500 1,000 1,000 Number of responses per respondent Average burden per response (in hours) 1 1 1 5/60 10/60 35/60 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) 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 E:\FR\FM\18JNN1.SGM 18JNN1 28234 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 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 Number of respondents Type of respondents Form name Claimant .......................................................... Claimant .......................................................... Initial Interview ............................................... Conclusion form OCAS–1 .............................. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0286] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants amozie on DSK3GDR082PROD with NOTICES1 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. SUMMARY: VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 3,600 3,600 Number of responses per respondent Average burden per response (in hours) 1 1 1 5/60 Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on formal meetings between FDA and biosimilar biological product sponsors or applicants. DATES: Submit either electronic or written comments on the collection of information by August 17, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28233-28234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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


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