80 FR 14143 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 52 (March 18, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 52 (March 18, 2015)
| Page Range | 14143-14145 | |
| FR Document | 2015-06160 |
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)] [Notices] [Pages 14143-14145] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06160] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-0020] 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 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. Written comments and/or suggestions regarding the items contained in this notice should be directed 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 Coal Workers' Health Surveillance Program (CWHSP)--(0920-0020)-- Reinstatement with Change--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description NIOSH would like to submit an Information Collection Request (ICR) to revise the data collection instruments being utilized within the Coal Workers' Health Surveillance Program (CWHSP). On May 1, 2014, the Mine Safety and Health Administration (MSHA) published final rule 30 CFR 70, 71, 72, 75, and 90. The new MSHA rule added surface coal miners, a respiratory health assessment, and spirometry testing for chronic obstructive pulmonary disease (COPD) to the previously mandated chest x-ray examination program. These additions are being referred to as the Expanded CWHSP (an additional component under the current CWHSP). This request incorporates all components that now fall under the CWHSP. Those components include: Coal Workers' X-ray Surveillance Program (CWXSP), B Reader Program, Enhanced Coal Workers' Health Surveillance Program (ECWHSP), Expanded Coal Workers' Health Surveillance Program, and National Coal Workers' Autopsy Study (NCWAS). The CWHSP is a congressionally-mandated medical examination program for monitoring the health of coal miners. The Program was originally authorized under the 1969 Federal Coal Mine Health and Safety Act and is currently authorized under the 1977 Federal Mine Safety and Health Act and its subsequent amendments (the Act). The Act provides the regulatory authority for [[Page 14144]] the administration of the CWHSP. This Program, which operates in accordance with 42 CFR part 37, is useful in providing information for protecting the health of miners (whose participation is entirely voluntary), and also in documenting trends and patterns in the prevalence of coal workers' pneumoconiosis (`black lung' disease) among miners employed in U.S. coal mines. The total estimated annualized burden hours of 20,282 is based on the following collection instruments:Coal Mine Operator Plan (2.10) and Coal Contractor Plan (2.18)--Under 42 CFR part 37, every coal operator and coal contractor in the U.S. must submit a plan approximately every 4 years, providing information on how they plan to notify their miners of the opportunity to obtain the medical examination. Completion of this form with all requested information (including a roster of current employees) takes approximately 30 minutes. Radiographic Facility Certification Document (2.11)--X-ray facilities seeking NIOSH approval to provide miner radiographs under the CWHSP must complete an approval packet including this form which requires approximately 30 minutes for completion. Miner Identification Document (2.9)--Miners who elect to participate in the CWHSP must fill out this document which requires approximately 20 minutes. This document records demographic and occupational history, as well as information required under the regulations in relation to the examinations. In addition to completing this form, acquiring the chest image from the miner takes approximately 15 minutes. Chest Radiograph Classification Form (2.8)--NIOSH utilizes a radiographic classification system developed by the International Labour Office (ILO) in the determination of pneumoconiosis among coal miners. Physicians (B Readers) fill out this form regarding their interpretations of the radiographs (each image has two separate interpretations, and approximately 7% of the images require additional interpretations). Based on prior practice it takes the physician approximately 3 minutes per form. Physician Application for Certification (2.12)--Physicians taking the B Reader examination are asked to complete this registration form which provides demographic information as well as information regarding their medical practices. It typically takes the physician about 10 minutes to complete this form. Spirometry Facility Certification Document (2.14)--This new form is analogous to the Radiographic Facility Certification Document (2.11) and records the spirometry facility equipment/staffing information. Spirometry facilities seeking NIOSH approval to provide miner spirometry testing under the CWHSP must complete an approval packet which includes this form. It is estimated that it will take approximately 30 minutes for this form to be completed at the facility. Respiratory Assessment Form (2.13)--This new form is designed to assess respiratory symptoms and certain medical conditions and risk factors. It is estimated that it will take approximately five minutes for administration of this form to the miner by an employee at the facility. Spirometry Results Notification Form (2.15)--This new form replaces previous forms 2.15, 2.16 and 2.17. It is used to: collect information that will allow NIOSH to identify the miner in order to provide notification of the spirometry test results; assure that the test can be done safely; record certain factors that can affect test results; provide documentation that the required components of the spirometry examination have been transmitted to NIOSH for processing; and conduct quality assurance audits and interpretation of results. It is estimated that it will take the facility approximately 20 minutes to complete this form. In addition to completing this form, acquiring an acceptable spirometry test from the miner takes approximately 15 minutes. Pathologist Invoice--Under the NCWAS, the invoice submitted by the pathologist must contain a statement that the pathologist is not receiving any other compensation for the autopsy. Each participating pathologist may use their individual invoice as long as this statement is added. It is estimated that only five minutes is required for the pathologist to add this statement to the standard invoice that they routinely use. Pathologist Report--Under the NCWAS the pathologist must submit information found at autopsy, slides, blocks of tissue, and a final diagnosis indicating presence or absence of pneumoconiosis. The format of the autopsy reports is variable depending on the pathologist conducting the autopsy. Since an autopsy report is routinely completed by a pathologist, the only additional burden is the specific request for a clinical abstract of terminal illness and final diagnosis relating to pneumoconiosis. Therefore, only 5 minutes of additional burden is estimated for the pathologist's report. Consent, Release and History Form (2.6)--This form documents written authorization from the next-of-kin to perform an autopsy on the deceased miner. A minimum of essential information is collected regarding the deceased miner including an occupational history and a smoking history. From past experience, it is estimated that 15 minutes is required for the next-of-kin to complete this form. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondent Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Coal Mine Operator.................... 2.10.................... 388 1 30/60 Coal Mine Contractor.................. 2.18.................... 575 1 30/60 Radiograph Facility Supervisor........ 2.11.................... 40 1 30/60 Coal Miner............................ 2.9..................... 14,560 1 20/60 Coal Miner--Radiograph................ No form required........ 14,560 1 15/60 B Reader Physician.................... 2.8..................... 10 3014 3/60 Physicians taking the B Reader 2.12.................... 100 1 10/60 Examination. Spirometry Facility Supervisor........ 2.14.................... 100 1 30/60 Spirometry Facility Employee.......... 2.13.................... 14,560 1 5/60 Spirometry Technician................. 2.15.................... 14,560 1 20/60 Coal Mine--Spirometry................. No form required........ 14,560 1 15/60 Pathologist........................... Invoice--No standard 5 1 5/60 form. [[Page 14145]] Pathologist........................... Pathology Report--No 5 1 5/60 standard form. Next-of-kin for deceased miner........ 2.6..................... 5 1 15/60 ---------------------------------------------------------------------------------------------------------------- Leroy A. Richardson, 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. 2015-06160 Filed 3-17-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14143
Name of Committee: Center for Scientific 085: Metabolic Reprogramming in the collection of information on those
Review Special Emphasis Panel; Program Immunotherapy. who are to respond, including through
Project: National Biomedical NMR Resource. Date: March 17, 2015. the use of appropriate automated,
Date: April 13–15, 2015. Time: 1:30 p.m. to 4:00 p.m.
electronic, mechanical, or other
Time: 7:00 p.m. to 12:00 p.m. Agenda: To review and evaluate grant
Agenda: To review and evaluate grant applications. technological collection techniques or
applications. Place: National Institutes of Health, 6701 other forms of information technology,
Place: Doubletree Hotel Bethesda, Rockledge Drive, Bethesda, MD 20892, e.g., permitting electronic submission of
(Formerly Holiday Inn Select), 8120 (Telephone Conference Call). responses; and (e) Assess information
Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Denise R Shaw, Ph.D., collection costs.
Contact Person: Michael Eissenstat, Ph.D., Scientific Review Officer, Center for To request additional information on
Scientific Review Officer, BCMB IRG, Center Scientific Review, National Institutes of the proposed project or to obtain a copy
for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, of the information collection plan and
Health, 6701 Rockledge Drive, Room 4166, MSC 7804, Bethesda, MD 20892, 301–435–
Bethesda, MD 20892, 301–435–1722, 0198, shawdeni@csr.nih.gov. instruments, call (404) 639–7570 or
eissenstatma@csr.nih.gov. send an email to omb@cdc.gov. Written
This notice is being published less than 15
Name of Committee: Center for Scientific days prior to the meeting due to the timing comments and/or suggestions regarding
Review Special Emphasis Panel; Member limitations imposed by the review and the items contained in this notice
Conflict: AIDS and AIDS Related Research. funding cycle. should be directed to the Attention:
Date: April 13, 2015. (Catalogue of Federal Domestic Assistance CDC Desk Officer, Office of Management
Time: 12:00 p.m. to 5:00 p.m. Program Nos. 93.306, Comparative Medicine; and Budget, Washington, DC 20503 or
Agenda: To review and evaluate grant 93.333, Clinical Research, 93.306, 93.333, by fax to (202) 395–5806. Written
applications. 93.337, 93.393–93.396, 93.837–93.844, comments should be received within 30
Place: National Institutes of Health, 6701 93.846–93.878, 93.892, 93.893, National
Rockledge Drive, Bethesda, MD 20892, days of this notice.
Institutes of Health, HHS)
(Telephone Conference Call). Proposed Project
Contact Person: Eduardo A Montalvo, Dated: March 12, 2015.
Ph.D., Scientific Review Officer, Center for Carolyn A. Baum, Coal Workers’ Health Surveillance
Scientific Review, National Institutes of Program Analyst, Office of Federal Advisory Program (CWHSP)—(0920–0020)—
Health, 6701 Rockledge Drive, Room 5108, Committee Policy. Reinstatement with Change—National
MSC 7852, Bethesda, MD 20892, (301) 435– [FR Doc. 2015–06120 Filed 3–17–15; 8:45 am] Institute for Occupational Safety and
1168, montalve@csr.nih.gov. Health (NIOSH), Centers for Disease
BILLING CODE 4140–01–P
(Catalogue of Federal Domestic Assistance Control and Prevention (CDC).
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333, Background and Brief Description
93.337, 93.393–93.396, 93.837–93.844, DEPARTMENT OF HEALTH AND
HUMAN SERVICES NIOSH would like to submit an
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Information Collection Request (ICR) to
Centers for Disease Control and revise the data collection instruments
Dated: March 12, 2015. Prevention being utilized within the Coal Workers’
Carolyn A. Baum, Health Surveillance Program (CWHSP).
Program Analyst, Office of Federal Advisory [30Day–15–0020] On May 1, 2014, the Mine Safety and
Committee Policy. Health Administration (MSHA)
Agency Forms Undergoing Paperwork
[FR Doc. 2015–06121 Filed 3–17–15; 8:45 am]
Reduction Act Review published final rule 30 CFR 70, 71, 72,
BILLING CODE 4140–01–P 75, and 90. The new MSHA rule added
The Centers for Disease Control and surface coal miners, a respiratory health
Prevention (CDC) has submitted the assessment, and spirometry testing for
DEPARTMENT OF HEALTH AND following information collection request chronic obstructive pulmonary disease
HUMAN SERVICES to the Office of Management and Budget (COPD) to the previously mandated
(OMB) for review and approval in chest x-ray examination program. These
National Institutes of Health accordance with the Paperwork additions are being referred to as the
Reduction Act of 1995. The notice for Expanded CWHSP (an additional
Center for Scientific Review; Notice of
Closed Meeting the proposed information collection is component under the current CWHSP).
published to obtain comments from the This request incorporates all
Pursuant to section 10(d) of the public and affected agencies. components that now fall under the
Federal Advisory Committee Act, as Written comments and suggestions CWHSP. Those components include:
amended (5 U.S.C. App.), notice is from the public and affected agencies Coal Workers’ X-ray Surveillance
hereby given of the following meeting. concerning the proposed collection of Program (CWXSP), B Reader Program,
The meeting will be closed to the information are encouraged. Your Enhanced Coal Workers’ Health
public in accordance with the comments should address any of the Surveillance Program (ECWHSP),
provisions set forth in sections following: (a) Evaluate whether the Expanded Coal Workers’ Health
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., proposed collection of information is Surveillance Program, and National
as amended. The grant applications and necessary for the proper performance of Coal Workers’ Autopsy Study (NCWAS).
the discussions could disclose the functions of the agency, including The CWHSP is a congressionally-
confidential trade secrets or commercial whether the information will have mandated medical examination program
property such as patentable material,
mstockstill on DSK4VPTVN1PROD with NOTICES
practical utility; (b) Evaluate the for monitoring the health of coal miners.
and personal information concerning accuracy of the agencies estimate of the The Program was originally authorized
individuals associated with the grant burden of the proposed collection of under the 1969 Federal Coal Mine
applications, the disclosure of which information, including the validity of Health and Safety Act and is currently
would constitute a clearly unwarranted the methodology and assumptions used; authorized under the 1977 Federal Mine
invasion of personal privacy. (c) Enhance the quality, utility, and Safety and Health Act and its
Name of Committee: Center for Scientific clarity of the information to be subsequent amendments (the Act). The
Review Special Emphasis Panel; PAR–14– collected; (d) Minimize the burden of Act provides the regulatory authority for
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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Pathologist ...................................................... Pathology Report—No standard form ............ 5 1 5/60
Next-of-kin for deceased miner ...................... 2.6 .................................................................. 5 1 15/60
Leroy A. Richardson, dispensed to a new calculation of AAC Any individual or group that wants to
Chief, Information Collection Review Office, adjusted by a multiplier of 1.1 for participate in the hearing as a party
Office of Scientific Integrity, Office of the multiple source drugs and 1.01 for must petition the presiding officer
Associate Director for Science, Office of the single source drugs. In addition, within 15 days after publication of this
Director, Centers for Disease Control and propose a reimbursement methodology notice, in accordance with the
Prevention. of wholesale acquisition cost (WAC) requirements contained at 42 CFR
[FR Doc. 2015–06160 Filed 3–17–15; 8:45 am] adjusted by a multiplier of 1.05 for state- 430.76(b)(2). Any interested person or
BILLING CODE 4163–18–P defined specialty therapeutic classes of organization that wants to participate as
drugs. amicus curiae must petition the
The issues to be considered at the presiding officer before the hearing
DEPARTMENT OF HEALTH AND begins in accordance with the
hearing are:
HUMAN SERVICES requirements contained at 42 CFR
• Whether the state’s proposed
Centers for Medicare & Medicaid increased payment methodology under 430.76(c). If the hearing is later
Services Louisiana Medicaid SPA 12–66–B rescheduled, the presiding officer will
complies with the requirements of notify all participants.
Notice of Hearing: Reconsideration of section 1902(a)(30)(A) of the Act which The notice to Louisiana announcing
Disapproval Louisiana Medicaid State requires, in part, that states have an administrative hearing to reconsider
Plan Amendment (SPA) 12–66–B methods and procedures to assure that the disapproval of its SPA reads as
payment rates are consistent with follows:
AGENCY: Centers for Medicare & J. Ruth Kennedy
Medicaid Services (CMS), HHS. efficiency, economy, and quality of care.
State Medicaid Director
ACTION: Notice of hearing:
• Whether the state demonstrated that Louisiana Department of Health and
Reconsideration of disapproval. the proposed payment increases are Hospitals
consistent with the aggregate upper 628 N. 4th Street
SUMMARY: This notice announces an payment limits set in implementing P.O. Box 91030
administrative hearing to be held on regulations at 42 CFR 447.512 which Baton Rouge, LA 70821
April 30, 2015, at the Department of provide that payments for drugs are to Dear Ms. Kennedy:
Health and Human Services, Centers for be based on the lower of: (1) The I am responding to your request for
Medicare and Medicaid Services, ingredient EAC of the drug and a reconsideration of the decision to disapprove
Division of Medicaid & Children’s reasonable dispensing fee; or (2) the Louisiana’s Medicaid state plan amendment
Health, Dallas Regional Office, 1301 provider’s usual and customary charges (SPA) 12–66B, which was submitted to the
to the general public. Centers for Medicare and Medicaid Services
Young Street, Room 730, Dallas, TX
(CMS) on December 20, 2012, and
75202, to reconsider CMS’ decision to • Whether the proposed calculation disapproved on December 11, 2014. I am
disapprove Louisiana’s Medicaid SPA of EAC used in calculating upper scheduling a hearing on your request for
12–66–B. payment limits (based on a multiple of reconsideration to be held on April 30, 2015,
Closing Date: Requests to participate the AAC) is consistent with the at the Department of Health and Human
in the hearing as a party must be definition of EAC in 42 CFR 447.502, Services, Centers for Medicare and Medicaid
received by the presiding officer by which defines EAC as ‘‘the agency’s best Services, Division of Medicaid & Children’s
April 2, 2015. Health, Dallas Regional Office, 1301 Young
estimate of the price generally and
Street, Room 730, Dallas, TX 75202.
FOR FURTHER INFORMATION CONTACT: currently paid by providers for a drug I am designating Mr. Benjamin R. Cohen as
Benjamin R. Cohen, Presiding Officer, marketed or sold by a particular the presiding officer. If these arrangements
CMS, 2520 Lord Baltimore Drive, Suite manufacturer or labeler in the package present any problems, please contact Mr.
L, Baltimore, Maryland 21244, size of drug most frequently purchased Cohen at (410) 786–3169. In order to
Telephone: (410) 786–3169. by providers.’’ facilitate any communication that may be
SUPPLEMENTARY INFORMATION: This Section 1116 of the Act and federal necessary between the parties prior to the
hearing, please notify the presiding officer to
notice announces an administrative regulations at 42 CFR part 430, establish indicate acceptability of the hearing date that
hearing to reconsider CMS’ decision to Department procedures that provide an has been scheduled and provide names of the
disapprove Louisiana’s Medicaid SPA administrative hearing for individuals who will represent the state at
12–66B which was submitted to the reconsideration of a disapproval of a the hearing. If the hearing date is not
Centers for Medicare and Medicaid state plan or plan amendment. CMS is acceptable, Mr. Cohen can set another date
mutually agreeable to the parties. The
mstockstill on DSK4VPTVN1PROD with NOTICES
Services (CMS) on December 20, 2012 required to publish a copy of the notice
and disapproved on December 11, 2014. to a state Medicaid agency that informs hearing will be governed by the procedures
In part, this SPA requested CMS the agency of the time and place of the prescribed by federal regulations at 42 CFR
part 430.
approval to revise the current pharmacy hearing, and the issues to be considered. In part, this SPA would revise the current
reimbursement methodology for If we subsequently notify the agency of pharmacy reimbursement methodology for
estimated acquisition cost (EAC) which additional issues that will be considered estimated acquisition cost (EAC) which is
is currently calculated as average at the hearing, we will also publish that currently calculated as average acquisition
acquisition cost (AAC) of the drug notice. cost (AAC) of the drug dispensed to a new
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Document Created: 2018-02-21 09:39:30
Document Modified: 2018-02-21 09:39:30
| 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 | 80 FR 14143 |
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