83 FR 48428 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 186 (September 25, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 186 (September 25, 2018)
| Page Range | 48428-48430 | |
| FR Document | 2018-20807 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48428-48430] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20807] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-0891] 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 World Trade Center Health Program Enrollment, Treatment, Appeals & Reimbursement 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 May 11, 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 World Trade Center Health Program Enrollment, Treatment, Appeals & Reimbursement (OMB Control No. 0920-0891, Expires 09/30/2018)-- Revision--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description NIOSH seeks to request OMB approval to revise the currently approved information collection activities that support the World Trade Center (WTC) Health Program. The James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114- 113) created the WTC Health Program to provide medical monitoring and treatment benefits to eligible individuals affected by the terrorist attacks on September 11, 2001. Eligible individuals include firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors). This request also seeks to incorporate information collection previously approved under the World Trade Center Health Program Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program (OMB No. 0920-0929, expiration date 7/31/2018), which has been discontinued. The revision of OMB No. 0920-0891 will provide a comprehensive summary of information collection needed to administer the World Trade Center Health Program. Since its inception in 2011, the WTC Health Program has been approved to collect information from applicants and Program members (enrolled WTC responders and survivors) concerning eligibility and enrollment, appointment of a designated representative, medical care, travel reimbursement, and appeal [[Page 48429]] of adverse Program decisions. The WTC Health Program is also currently approved to collect information from Program medical providers, including health condition certification requests and pharmaceutical claims. The WTC Health Program has determined that some existing forms need to be updated, and new information collections related to a recent rulemaking should be added. Changes to WTC Health Program regulations in 42 CFR part 88 will require the extension of existing information collections. Specifically, 42 CFR 88.13 establishes procedures for the appeal of Program decisions to disenroll Program members and deny enrollment to applicants. Appeals of enrollment denial decisions, which include the submission of appeal request letters, are currently approved; the Program proposes to extend this information collection to account for the burden of requests for appeal of disenrollment decisions. Of the over 70,000 Program members, we expect that 0.014 percent (10) will be subsequently disenrolled from the Program. Of those, we expect that 30 percent (3) will appeal the disenrollment decisions. We estimate that the disenrollment appeal requests will take no more than 0.5 hours per respondent. The annual burden estimate is 2 hours (rounded). Section 42 CFR 88.21 establishes procedures for the appeal of WTC Health Program decisions to decertify a WTC-related health condition, deny certification, and deny treatment authorization. Appeals of health condition certification denials and treatment authorization denials, which include the submission of appeal request letters, are currently approved; the Program proposes to extend this information collection to account for the burden of requests for appeal of decertification decisions. The information collection will also be expanded to allow Program members to provide additional information and/or an oral statement. Of the estimated 51,472 Program members who have at least one health condition certification, we estimate that 0.02 percent (10) will be decertified, and 50 percent (5) of those will appeal a decertification. We estimate that the appeal request letter will take no more than 0.5 hours per respondent. Providing additional information and/or an oral statement will take no more than one hour per respondent. The annual burden estimate for decertification appeals is 8 hours. We further estimate that Program members request certification for 20,000 health conditions each year. Of those 20,000, we estimate that one percent (200) of certification requests are denied by the WTC Health Program. We also expect that 30 percent of denied certifications, or 60 individuals, will be appealed. We estimate that the appeals letter takes no more than 30 minutes and providing additional information and/or an oral statement will take no more than one hour. The burden estimate for certification denial appeals is 90 hours. In addition, of the projected 51,472 Program members who receive medical care, we estimate that 0.05 percent (26) will appeal a determination by the WTC Health Program that the treatment being sought is not medically necessary. We estimate that the appeals letter will take no more than 30 minutes and providing additional information and/ or an oral statement will take no more than one hour. The burden estimate for treatment authorization denial appeals is 39 hours. Finally, 42 CFR 88.23 establishes procedures for the appeal of a WTC Health Program decision to deny reimbursement to a Program medical provider for treatment determined not to be medically necessary. Accordingly, the Program proposes the addition of information collected in the appeal request. We estimate that of the nearly 52,000 Program providers, we estimate that 1.15 percent (600) annually will be denied reimbursement for treatment found to be not medically necessary or in accordance with treatment protocols, and will appeal the decision. We estimate that the appeal letter will take no more than 0.5 hours to compile. The burden estimate for treatment reimbursement denial appeals is 300 hours. The revision request also includes the addition of a new form to allow applicants and Program members to grant permission to share information with a third person about an individual's application or case. We estimate that 30 applicants and members will submit a Health Insurance Portability and Accountability Act (HIPAA) Release Form annually. The form will to take no longer than 0.25 hours to complete. The burden estimate for the HIPAA Release form is 8 hours. The total estimated annualized burden hours are 14,063, an increase of 469 hours from the previously approved estimate of 13,594 hours. The revised estimate includes forms that have not been modified; changes due to the appeals processes authorized by 42 CFR 88.21 and 42 CFR 88.23; inclusion of the new HIPPA Release Form; incorporation of a form previously approved under OMB No. 0920-0929; and miscellaneous actions. The revision request provides a detailed summary of each change and its impact on the burden estimate. Background and Brief Description ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- FDNY Responder..................... World Trade Center Health 45 1 30/60 Program FDNY Responder Eligibility Application. General Responder.................. World Trade Center Health 2,475 1 30/60 Program Responder Eligibility Application (Other than FDNY). Pentagon/Shanksville Responder..... World Trade Center Health 630 1 30/60 Program Pentagon/ Shanksville Responder. WTC Survivor....................... World Trade Center Health 1,350 1 30/60 Program Survivor Eligibility Application (all languages). General responder.................. Clinic Selection Postcard 2,475 1 15/60 for new general responders in NY/NJ to select a clinic. Program Medical Provider........... Physician Request for 20,000 1 30/60 Certification (WTC-3). Responder (FDNY and General Denial Letter and Appeal 45 1 30/60 Responder)/Survivor. Notification--Enrollment. Responder (FDNY and General Disenrollment Letter and 3 1 30/60 Responder)/Survivor. Appeal Notification-- Enrollment. [[Page 48430]] Responder (FDNY and General Decertification Letter and 5 1 1.5 Responder)/Survivor. Appeal Notification-- Health Condition. Responder (FDNY and General Denial Letter and Appeal 60 1 1.5 Responder)/Survivor. Notification--Health Condition Certification. Responder (FDNY and General Denial Letter and Appeal 26 1 1.5 Responder)/Survivor. Notification--Treatment Authorization. Responder (FDNY and General WTC Health Program Medical 10 1 10/60 Responder)/Survivor. Travel Refund Request. Program Members.................... Designated Representative 30 1 15/60 Form. Program Member..................... HIPAA Release Form to allow 30 1 15/60 the sharing of member information with a third party. Pharmacy........................... Outpatient prescription 150 261 1/60 pharmaceuticals. Program Medical Provider........... Reimbursement Denial Letter 600 1 30/60 and Appeal Notification-- Providers. Responder/Survivor/Advocate Petition for the addition 60 1 1 (physician). of health conditions. ---------------------------------------------------------------------------------------------------------------- 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. 2018-20807 Filed 9-24-18; 8:45 am] BILLING CODE 4163-18-P
![48428 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
threats, both domestically and Dated: August 17, 2018. instruments, call (404) 639–7570 or
internationally to its components, Alex M. Azar II, send an email to omb@cdc.gov. Direct
which are as follows: Secretary. written comments and/or suggestions
Æ Center for Global Health (CBB) [FR Doc. 2018–20835 Filed 9–24–18; 8:45 am] regarding the items contained in this
Æ Center for Preparedness and Response BILLING CODE 4160–18–P
notice to the Attention: CDC Desk
(CBC) Officer, Office of Management and
Æ Center for State, Tribal, Local and Budget, 725 17th Street NW,
Territorial Support (CBD) DEPARTMENT OF HEALTH AND Washington, DC 20503 or by fax to (202)
Æ Office of Minority Health and Health HUMAN SERVICES 395–5806. Provide written comments
Equity (CBE) within 30 days of notice publication.
• Deputy Director for Public Health Centers for Disease Control and
Proposed Project
Science and Surveillance (CP): The Prevention
World Trade Center Health Program
Deputy Director for Public Health [30Day–18–0891] Enrollment, Treatment, Appeals &
Science and Surveillance leads,
Reimbursement (OMB Control No.
promotes, and facilitates science, Agency Forms Undergoing Paperwork
0920–0891, Expires 09/30/2018)—
surveillance, standards and policies to Reduction Act Review
Revision—National Institute for
reduce the burden of diseases in the
In accordance with the Paperwork Occupational Safety and Health
United States and globally to its (NIOSH), Centers for Disease Control
Reduction Act of 1995, the Centers for
components, which are as follows: and Prevention (CDC).
Disease Control and Prevention (CDC)
Æ National Center for Health Statistics has submitted the information
(CPC) Background and Brief Description
collection request titled World Trade
Æ Center for Surveillance, Center Health Program Enrollment, NIOSH seeks to request OMB
Epidemiology, and Laboratory Treatment, Appeals & Reimbursement to approval to revise the currently
Services (CPN) the Office of Management and Budget approved information collection
Æ Office of Science (CPP) (OMB) for review and approval. CDC activities that support the World Trade
Æ Office of Laboratory Science and previously published a ‘‘Proposed Data Center (WTC) Health Program. The
Safety (CPQ) Collection Submitted for Public James Zadroga 9/11 Health and
• Deputy Director for Non-Infectious Comment and Recommendations’’ Compensation Act of 2010 (Pub. L. 111–
Diseases (CU): The Deputy Director for notice on May 11, 2018, to obtain 347, as amended by Pub. L. 114–113)
Non-Infectious Diseases reduces the comments from the public and affected created the WTC Health Program to
burden of non-infectious diseases, agencies. CDC did not receive comments provide medical monitoring and
injuries, birth defects, disabilities and related to the previous notice. This treatment benefits to eligible individuals
environmental health hazards to its notice serves to allow an additional 30 affected by the terrorist attacks on
components, which are as follows: days for public and affected agency September 11, 2001. Eligible individuals
Æ National Center on Birth Defects and comments. include firefighters and related
Developmental Disabilities (CUB) CDC will accept all comments for this personnel, law enforcement officers,
Æ National Center for Chronic Disease proposed information collection project. and rescue, recovery, and cleanup
Prevention and Health Promotion The Office of Management and Budget workers who responded to the attacks in
(CUC) is particularly interested in comments New York City, at the Pentagon, and in
Æ National Center for Environmental that: Shanksville, Pennsylvania (responders),
Health/Agency for Toxic Substances (a) Evaluate whether the proposed and to eligible persons who were
and Disease Registry (CUG) collection of information is necessary present in the dust or dust cloud on
Æ National Center for Injury Prevention for the proper performance of the September 11, 2001, or who worked,
and Control (CUH) functions of the agency, including resided, or attended school, childcare,
• Deputy Director for Infectious whether the information will have or adult daycare in the New York City
Diseases (CV): Deputy Director for practical utility; disaster area (survivors).
Infectious Diseases leads, promotes, and (b) Evaluate the accuracy of the This request also seeks to incorporate
facilitates science, programs, and agencies estimate of the burden of the information collection previously
policies to reduce the burden of proposed collection of information, approved under the World Trade Center
infectious disease in the United States including the validity of the Health Program Petition for the
and globally and its components, which methodology and assumptions used; Addition of a New WTC-Related Health
are as follows: (c) Enhance the quality, utility, and Condition for Coverage under the World
clarity of the information to be Trade Center (WTC) Health Program
Æ National Center for Immunization and
collected; (OMB No. 0920–0929, expiration date 7/
Respiratory Diseases (CVG)
(d) Minimize the burden of the 31/2018), which has been discontinued.
Æ National Center for Emerging and
collection of information on those who The revision of OMB No. 0920–0891
Zoonotic Infectious Diseases (CVL)
are to respond, including, through the will provide a comprehensive summary
Æ National Center for HIV/AIDS, Viral
use of appropriate automated, of information collection needed to
Hepatitis, STD and TB Prevention
electronic, mechanical, or other administer the World Trade Center
IV. Delegations of Authority: All technological collection techniques or Health Program.
delegations and redelegations of other forms of information technology, Since its inception in 2011, the WTC
daltland on DSKBBV9HB2PROD with NOTICES
authority made to officials and e.g., permitting electronic submission of Health Program has been approved to
employees of affected organizational responses; and collect information from applicants and
components will continue in them or (e) Assess information collection Program members (enrolled WTC
their successors pending further costs. responders and survivors) concerning
redelegation, provided they are To request additional information on eligibility and enrollment, appointment
consistent with this reorganization. the proposed project or to obtain a copy of a designated representative, medical
Authority: 44 U.S.C. 3101. of the information collection plan and care, travel reimbursement, and appeal
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![48430 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
BACKGROUND AND BRIEF DESCRIPTION—Continued
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Responder (FDNY and General Re- Decertification Letter and Appeal Notification— 5 1 1.5
sponder)/Survivor. Health Condition.
Responder (FDNY and General Re- Denial Letter and Appeal Notification—Health Condi- 60 1 1.5
sponder)/Survivor. tion Certification.
Responder (FDNY and General Re- Denial Letter and Appeal Notification—Treatment 26 1 1.5
sponder)/Survivor. Authorization.
Responder (FDNY and General Re- WTC Health Program Medical Travel Refund Re- 10 1 10/60
sponder)/Survivor. quest.
Program Members .............................. Designated Representative Form ............................... 30 1 15/60
Program Member ............................... HIPAA Release Form to allow the sharing of mem- 30 1 15/60
ber information with a third party.
Pharmacy ........................................... Outpatient prescription pharmaceuticals .................... 150 261 1/60
Program Medical Provider .................. Reimbursement Denial Letter and Appeal Notifica- 600 1 30/60
tion—Providers.
Responder/Survivor/Advocate (physi- Petition for the addition of health conditions .............. 60 1 1
cian).
Jeffrey M. Zirger, ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper
Acting Chief, Information Collection Review as follows. Please note that late, Submissions’’ and ‘‘Instructions’’).
Office, Office of Scientific Integrity, Office untimely filed comments will not be
of the Associate Director for Science, Office Written/Paper Submissions
considered. Electronic comments must
of the Director, Centers for Disease Control be submitted on or before November 26, Submit written/paper submissions as
and Prevention. 2018. The https://www.regulations.gov follows:
[FR Doc. 2018–20807 Filed 9–24–18; 8:45 am] electronic filing system will accept • Mail/Hand Delivery/Courier (for
BILLING CODE 4163–18–P comments until 11:59 p.m. Eastern Time written/paper submissions): Dockets
at the end of November 26, 2018. Management Staff (HFA–305), Food and
Comments received by mail/hand Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND delivery/courier (for written/paper Lane, Rm. 1061, Rockville, MD 20852.
HUMAN SERVICES submissions) will be considered timely • For written/paper comments
if they are postmarked or the delivery submitted to the Dockets Management
Food and Drug Administration Staff, FDA will post your comment, as
service acceptance receipt is on or
[Docket No. FDA–2018–N–3404] well as any attachments, except for
before that date.
information submitted, marked and
Agency Information Collection Electronic Submissions identified, as confidential, if submitted
Activities; Proposed Collection; as detailed in ‘‘Instructions.’’
Submit electronic comments in the Instructions: All submissions received
Comment Request; Generic Drug User following way:
Fee Cover Sheet must include the Docket No. FDA–
• Federal eRulemaking Portal: 2018–N–3404 for ‘‘Agency Information
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the Collection Activities; Proposed
HHS. instructions for submitting comments. Collection; Comment Request; Generic
ACTION: Notice. Comments submitted electronically, Drug User Fee Cover Sheet.’’ Received
including attachments, to https:// comments, those filed in a timely
SUMMARY: The Food and Drug www.regulations.gov will be posted to manner (see ADDRESSES), will be placed
Administration (FDA or Agency) is the docket unchanged. Because your in the docket and, except for those
announcing an opportunity for public comment will be made public, you are submitted as ‘‘Confidential
comment on the proposed collection of solely responsible for ensuring that your Submissions,’’ publicly viewable at
certain information by the Agency. comment does not include any https://www.regulations.gov or at the
Under the Paperwork Reduction Act of confidential information that you or a Dockets Management Staff between 9
1995 (PRA), Federal Agencies are third party may not wish to be posted, a.m. and 4 p.m., Monday through
required to publish notice in the such as medical information, your or Friday.
Federal Register concerning each anyone else’s Social Security number, or • Confidential Submissions—To
proposed collection of information, confidential business information, such submit a comment with confidential
including each proposed extension of an as a manufacturing process. Please note information that you do not wish to be
existing collection of information, and that if you include your name, contact made publicly available, submit your
to allow 60 days for public comment in information, or other information that comments only as a written/paper
response to the notice. This notice identifies you in the body of your submission. You should submit two
daltland on DSKBBV9HB2PROD with NOTICES
solicits comments on collection of comments, that information will be copies total. One copy will include the
information using Form FDA 3794, posted on https://www.regulations.gov. information you claim to be confidential
entitled ‘‘Generic Drug User Fee Cover • If you want to submit a comment with a heading or cover note that states
Sheet.’’ with confidential information that you ‘‘THIS DOCUMENT CONTAINS
DATES: Submit either electronic or do not wish to be made available to the CONFIDENTIAL INFORMATION.’’ The
written comments on the collection of public, submit the comment as a Agency will review this copy, including
information by November 26, 2018. written/paper submission and in the the claimed confidential information, in
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Document Created: 2018-09-25 00:21:57
Document Modified: 2018-09-25 00:21:57
| 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 48428 |
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