81 FR 7124 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 27 (February 10, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 27 (February 10, 2016)
| Page Range | 7124-7126 | |
| FR Document | 2016-02686 |
[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)] [Notices] [Pages 7124-7126] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02686] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-276, CMS-1957, CMS-10599 and CMS-10600] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by April 11, 2016: ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for ``Comment or Submission'' or ``More Search Options'' to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786- 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-276 Prepaid Health Plan Cost Report CMS-1957 Social Security Office (SSO) Report of State Buy-in Problem CMS-10599 Medicare Prior Authorization of Home Health Services Demonstration CMS-10600 Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management [[Page 7125]] and Budget (OMB) for each collection of information they conduct or sponsor. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Prepaid Health Plan Cost Report; Use: Health Maintenance Organizations and Competitive Medical Plans (HMO/CMPs) contracting with the Secretary under Section 1876 of the Social Security Act are required to submit a budget and enrollment forecast, semi-annual interim report, 4th Quarter interim report, and a final certified cost report in accordance with 42 CFR 417.572-417.576. Health Care Prepayment Plans (HCPPs) contracting with the Secretary under Section 1833 of the Social Security Act are required to submit a budget and enrollment forecast, semi-annual interim report, and final cost report in accordance with 42 CFR 417.808 and 42 CFR 417.810. Form Number: CMS-276 (OMB control number 0938- 0165); Frequency: Quarterly; Affected Public: Private Sector (Business or other for-profits); Number of Respondents: 91; Total Annual Responses: 74; Total Annual Hours: 3728. (For policy questions regarding this collection contact Bilal Farrakh at 410-786-4456.) 2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Social Security Office (SSO) Report of State Buy-in Problem; Use: Under Section 1843 of the Social Security Act, States may enter into an agreement with the Department of Health and Human Services to enroll eligible individuals in Medicare and pay their premiums. The purpose of the State Buy-in' program is to assure that Medicaid is the payer of last resort by permitting a State to provide Medicare protection to certain groups of needy individuals, as part of the State's total assistance plan. State Buy-in also has the effect of transferring some medical costs for this population from the Medicaid program, which is partially State funded to the Medicare program, which is funded by the federal government and individual premiums. Generally, the States Buy- in for individuals who meet the eligibility requirements for Medicare and are cash recipients or deemed cash recipients or categorically needy under Medicaid. In some cases, States may also include individuals who are not cash assistance recipients under the Medical Assistance Only group. The day-to-day operations of the State Buy-in program is accomplished through an automated data exchange process. The automated data exchange process is used to exchange Medicare and Buy-in entitlement information between the Social Security District Offices, Medicaid State Agencies and the Centers for Medicare & Medicaid Services. When problems arise however that cannot be resolved though the normal data exchange process, clerical actions are required. The CMS-1957, ``SSO Report of State Buy-In Problem'' is used to report Buy- in problems cases. The CMS-1957 is the only standardized form available for communications between the aforementioned agencies for the resolution of beneficiary complaints and inquiries regarding State Buy- in eligibility. Form Number: CMS-1957 (OMB control number: 0938-0035); Frequency: Reporting--Annually; Affected Public: Individuals and Households; Number of Respondents: 3,936; Total Annual Responses: 3,936; Total Annual Hours: 1,311. (For policy questions regarding this collection contact Keith Robinson at 410-786-1148.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Prior Authorization of Home Health Services Demonstration; Use: Section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)) authorizes the Secretary to ``develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act (the Act).'' In accordance with this authority, we seek to develop and implement a Medicare demonstration project, which we believe will help assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among HHAs providing services to Medicare beneficiaries. This demonstration would help assure that payments for home health services are appropriate before the claims are paid, thereby preventing fraud, waste, and abuse. As part of this demonstration, we propose performing prior authorization before processing claims for home health services in: Florida, Texas, Illinois, Michigan, and Massachusetts. We would establish a prior authorization procedure that is similar to the Prior Authorization of Power Mobility Device (PMD) Demonstration, which was implemented by CMS in 2012. This demonstration would also follow and adopt prior authorization processes that currently exist in other health care programs such as TRICARE, certain state Medicaid programs, and in private insurance. The information required under this collection is requested by Medicare contractors to determine proper payment or if there is a suspicion of fraud. Medicare contractors will request the information from HHA providers submitting claims for payment from the Medicare program in advance to determine appropriate payment. Form Number: CMS- 10599 (OMB control number: 0938-NEW); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for- profits); Number of Respondents: 908,740; Number of Responses: 908,740; Total Annual Hours: 454,370. (For questions regarding this collection contact Carla David (410)786-4799.) 4. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration; Use: Primary Immune Deficiency Diseases (PIDD) are caused by genetic defects that result in a lack of and/or impaired antibody function. Without antibodies, the body's immune system is not able to function effectively. Immunoglobulin (IG) therapy is used to temporarily replace some of the antibodies (immunoglobulins) that are missing or not working properly in people with PIDD. By special statutory provision, Medicare Part B covers intravenous immunoglobulin (IVIG) for persons with PIDD who wish to receive the drug in-home, but does not allow for Medicare to cover any of the items and services needed to administer the drug unless the person is homebound or otherwise receiving services under a Medicare home health episode of care. Therefore, most beneficiaries with PIDD receive treatment at hospital outpatient departments, physicians' offices, and other outpatient settings. A current alternative to IVIG is subcutaneous immunoglobulin (SCIG), a product that [[Page 7126]] permits some beneficiaries to self-administer the immunoglobulin (IG) safely at home without an attending healthcare professional. SCIG at home is reimbursed by Medicare. However, there are limitations to SCIG--e.g., the need for more frequent administration and higher volumes of solution, which can reach a maximum absorbable level for some patients that is below their optimum IG treatment level--that inhibit more widespread use of SCIG. Under the Medicare Patient IVIG Access Demonstration project, by paying for the items and services needed to administer the IVIG drug in-home, Medicare will enable beneficiaries and their physicians to have greater flexibility in choosing the option that is most appropriate for the beneficiary. With the exception of coverage of these items and services, no other aspects of Medicare coverage for IVIG (e.g., drugs approved for coverage or PIDD diagnoses covered) will change under the demonstration. The Medicare Patient IVIG Access Demonstration project mandates CMS to:Evaluate the impact of the Medicare IVIG Access Demonstration project on Medicare beneficiary access to IVIG at home, Determine the appropriateness of implementing a new payment methodology for IVIG in all settings and determining an appropriate payment amount, and Update the existing 2007 Office of the Assistant Secretary for Planning and Evaluation (ASPE) report Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV) (2007 ASPE Report). The impact evaluation seeks to understand the experiences of demonstration participants and non-participants, to update the 2007 ASPE report, and to support the payment methodology through the use of qualitative and quantitative data collection. The qualitative data collection will consist of a series of stakeholder interviews. Interviews with IVIG/SCIG physicians and nurses will provide information on the experiences of beneficiaries from the perspective of those who have significant, in-depth and practical hands-on experience with delivering IG to Medicare beneficiaries with and without access to home infusions. We will be able to gather their knowledge of beneficiaries' experiences with the care, as well as information on any potential health consequences due to changes in IG medication or participation in the Demonstration. Lastly, we will gather the physicians and nurses' views of the degree to which beneficiaries believe the program is effective, including the cost effectiveness for beneficiaries who use the services provided under the Demonstration. Form Number: CMS-10600 (OMB control number: 0938-NEW); Frequency: Annually; Affected Public: Individuals and Households; State, Local or Tribal Governments; Private Sector (Business or other for-profit); Number of Respondents: 2,488; Total Annual Responses: 2,488; Total Annual Hours: 483. (For policy questions regarding this collection contact Pauline Karikari-Martin at 410-786-1040). Dated: February 5, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-02686 Filed 2-9-16; 8:45 am] BILLING CODE 4120-01-P
![7124 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
Contact Person for More Information: docket number NIOSH–260–A, by any minimize the information collection
Jaya Raman, Ph.D., Scientific Review of the following methods: burden.
Officer, CDC, 4770 Buford Highway, • Federal eRulemaking Portal: DATES: Comments must be received by
Mailstop F80, Atlanta, Georgia 30341, www.regulations.gov Follow the April 11, 2016:
Telephone: (770) 488–6511, kva5@ instructions for submitting comments.
ADDRESSES: When commenting, please
cdc.gov. • Mail: National Institute for
The Director, Management Analysis Occupational Safety and Health, NIOSH reference the document identifier or
and Services Office, has been delegated Docket Office, 1090 Tusculum Avenue, OMB control number. To be assured
the authority to sign Federal Register MS C–34, Cincinnati, Ohio 45226–1998. consideration, comments and
notices pertaining to announcements of recommendations must be submitted in
FOR FURTHER INFORMATION CONTACT: any one of the following ways:
meetings and other committee Charles Geraci, NIOSH, Education and
management activities, for both the 1. Electronically. You may send your
Information Division, Nanotechnology comments electronically to http://
Centers for Disease Control and Research Center, 1090 Tusculum
Prevention and the Agency for Toxic www.regulations.gov. Follow the
Avenue, Cincinnati, Ohio 45226, instructions for ‘‘Comment or
Substances and Disease Registry. telephone (513) 533–8339 (not a toll free Submission’’ or ‘‘More Search Options’’
Catherine Ramadei, number). to find the information collection
Acting Director, Management Analysis and Dated: February 3, 2016. document(s) that are accepting
Services Office, Centers for Disease Control John Howard, comments.
and Prevention. 2. By regular mail. You may mail
Director, National Institute for Occupational
[FR Doc. 2016–02582 Filed 2–9–16; 8:45 am] written comments to the following
Safety and Health, Centers for Disease Control
BILLING CODE 4163–18–P and Prevention. address: CMS, Office of Strategic
[FR Doc. 2016–02647 Filed 2–9–16; 8:45 am] Operations and Regulatory Affairs,
BILLING CODE 4163–19–P Division of Regulations Development,
DEPARTMENT OF HEALTH AND Attention: Document Identifier/OMB
HUMAN SERVICES Control Number __, Room C4–26–05,
Centers for Disease Control and DEPARTMENT OF HEALTH AND 7500 Security Boulevard, Baltimore,
Prevention HUMAN SERVICES Maryland 21244–1850.
To obtain copies of a supporting
[Docket Number CDC–2016–0001; NIOSH– Centers for Medicare & Medicaid statement and any related forms for the
260–A] Services proposed collection(s) summarized in
this notice, you may make your request
Draft Current Intelligence Bulletin: [Document Identifier: CMS–276, CMS–1957,
CMS–10599 and CMS–10600] using one of following:
Health Effects of Occupational
1. Access CMS’ Web site address at
Exposure to Silver Nanomaterials;
Agency Information Collection http://www.cms.hhs.gov/
Notice of Public Meeting; Availability
Activities: Proposed Collection; PaperworkReductionActof1995.
of Document for Comment; Extension
Comment Request 2. Email your request, including your
of Comment Period
address, phone number, OMB number,
AGENCY: National Institute for AGENCY: Centers for Medicare & and CMS document identifier, to
Occupational Safety and Health Medicaid Services, HHS. Paperwork@cms.hhs.gov.
(NIOSH) of the Centers for Disease ACTION: Notice. 3. Call the Reports Clearance Office at
Control and Prevention (CDC), (410) 786–1326.
Department of Health and Human SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT:
Services (HHS). Medicaid Services (CMS) is announcing Reports Clearance Office at (410) 786–
ACTION: Notice and extension of an opportunity for the public to 1326.
comment period. comment on CMS’ intention to collect
information from the public. Under the SUPPLEMENTARY INFORMATION:
SUMMARY: On January 21, 2016, the Paperwork Reduction Act of 1995 (the Contents
Director of the National Institute for PRA), federal agencies are required to
Occupational Safety and Health publish notice in the Federal Register This notice sets out a summary of the
(NIOSH) of the Centers for Disease concerning each proposed collection of use and burden associated with the
Control and Prevention (CDC), information (including each proposed following information collections. More
published a notice in the Federal extension or reinstatement of an existing detailed information can be found in
Register [81 FR 3425] announcing the collection of information) and to allow each collection’s supporting statement
availability of the following draft 60 days for public comment on the and associated materials (see
document for public comment entitled proposed action. Interested persons are ADDRESSES).
Draft Current Intelligence Bulletin: invited to send comments regarding our CMS–276 Prepaid Health Plan Cost
Health Effects of Occupational Exposure burden estimates or any other aspect of Report
to Silver Nanomaterials. Written this collection of information, including CMS–1957 Social Security Office (SSO)
comments were to be received by March any of the following subjects: (1) The Report of State Buy-in Problem
21, 2016. NIOSH is extending the public CMS–10599 Medicare Prior
asabaliauskas on DSK9F6TC42PROD with NOTICES2
necessity and utility of the proposed
comment period until April 22, 2016. information collection for the proper Authorization of Home Health
DATES: NIOSH is extending the performance of the agency’s functions; Services Demonstration
comment period on the document (2) the accuracy of the estimated CMS–10600 Evaluation of the Medicare
published January 21, 2016 (81 FR burden; (3) ways to enhance the quality, Patient Intravenous Immunoglobulin
3425). Electronic or written comments utility, and clarity of the information to Demonstration
must be received by April 22, 2016. be collected; and (4) the use of Under the PRA (44 U.S.C. 3501–
ADDRESSES: You may submit comments, automated collection techniques or 3520), federal agencies must obtain
identified by CDC–2016–0001 and other forms of information technology to approval from the Office of Management
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![7126 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
permits some beneficiaries to self- and nurses’ views of the degree to DATES: Comments on the collection(s) of
administer the immunoglobulin (IG) which beneficiaries believe the program information must be received by the
safely at home without an attending is effective, including the cost OMB desk officer by March 11, 2016.
healthcare professional. SCIG at home is effectiveness for beneficiaries who use ADDRESSES: When commenting on the
reimbursed by Medicare. However, the services provided under the proposed information collections,
there are limitations to SCIG—e.g., the Demonstration. Form Number: CMS– please reference the document identifier
need for more frequent administration 10600 (OMB control number: 0938– or OMB control number. To be assured
and higher volumes of solution, which NEW); Frequency: Annually; Affected consideration, comments and
can reach a maximum absorbable level Public: Individuals and Households; recommendations must be received by
for some patients that is below their State, Local or Tribal Governments; the OMB desk officer via one of the
optimum IG treatment level—that Private Sector (Business or other for- following transmissions: OMB, Office of
inhibit more widespread use of SCIG. profit); Number of Respondents: 2,488; Information and Regulatory Affairs,
Under the Medicare Patient IVIG Total Annual Responses: 2,488; Total Attention: CMS Desk Officer, Fax
Access Demonstration project, by Annual Hours: 483. (For policy Number: (202) 395–5806 OR, Email:
paying for the items and services questions regarding this collection OIRA_submission@omb.eop.gov.
needed to administer the IVIG drug in- contact Pauline Karikari-Martin at 410– To obtain copies of a supporting
home, Medicare will enable 786–1040). statement and any related forms for the
beneficiaries and their physicians to proposed collection(s) summarized in
Dated: February 5, 2016.
have greater flexibility in choosing the this notice, you may make your request
option that is most appropriate for the William N. Parham, III,
using one of following:
beneficiary. With the exception of Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
1. Access CMS’ Web site address at
coverage of these items and services, no http://www.cms.hhs.gov/
Affairs.
other aspects of Medicare coverage for PaperworkReductionActof1995.
IVIG (e.g., drugs approved for coverage [FR Doc. 2016–02686 Filed 2–9–16; 8:45 am]
2. Email your request, including your
or PIDD diagnoses covered) will change BILLING CODE 4120–01–P
address, phone number, OMB number,
under the demonstration. and CMS document identifier, to
The Medicare Patient IVIG Access Paperwork@cms.hhs.gov.
Demonstration project mandates CMS DEPARTMENT OF HEALTH AND
3. Call the Reports Clearance Office at
to: HUMAN SERVICES
(410) 786–1326.
• Evaluate the impact of the Medicare FOR FURTHER INFORMATION CONTACT:
IVIG Access Demonstration project on Centers for Medicare & Medicaid
Services Reports Clearance Office at (410) 786–
Medicare beneficiary access to IVIG at
1326.
home, [Document Identifiers: CMS–1728–94]
• Determine the appropriateness of SUPPLEMENTARY INFORMATION: Under the
implementing a new payment Agency Information Collection Paperwork Reduction Act of 1995 (PRA)
methodology for IVIG in all settings and Activities: Submission for OMB (44 U.S.C. 3501–3520), federal agencies
determining an appropriate payment Review; Comment Request must obtain approval from the Office of
amount, and Management and Budget (OMB) for each
• Update the existing 2007 Office of ACTION: Notice. collection of information they conduct
the Assistant Secretary for Planning and or sponsor. The term ‘‘collection of
Evaluation (ASPE) report Analysis of SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
Supply, Distribution, Demand, and Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
Access Issues Associated with Immune an opportunity for the public to includes agency requests or
Globulin Intravenous (IGIV) (2007 ASPE comment on CMS’ intention to collect requirements that members of the public
Report). information from the public. Under the submit reports, keep records, or provide
The impact evaluation seeks to Paperwork Reduction Act of 1995 information to a third party. Section
understand the experiences of (PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
demonstration participants and non- publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
participants, to update the 2007 ASPE concerning each proposed collection of to publish a 30-day notice in the
report, and to support the payment information, including each proposed Federal Register concerning each
methodology through the use of extension or reinstatement of an existing proposed collection of information,
qualitative and quantitative data collection of information, and to allow including each proposed extension or
collection. The qualitative data a second opportunity for public reinstatement of an existing collection
collection will consist of a series of comment on the notice. Interested of information, before submitting the
stakeholder interviews. Interviews with persons are invited to send comments collection to OMB for approval. To
IVIG/SCIG physicians and nurses will regarding the burden estimate or any comply with this requirement, CMS is
provide information on the experiences other aspect of this collection of publishing this notice that summarizes
of beneficiaries from the perspective of information, including any of the the following proposed collection(s) of
those who have significant, in-depth following subjects: (1) The necessity and information for public comment:
and practical hands-on experience with utility of the proposed information 1. Type of Information Collection
asabaliauskas on DSK9F6TC42PROD with NOTICES2
delivering IG to Medicare beneficiaries collection for the proper performance of Request: Revision of a currently
with and without access to home the agency’s functions; (2) the accuracy approved collection; Title of
infusions. We will be able to gather their of the estimated burden; (3) ways to Information Collection: Home Health
knowledge of beneficiaries’ experiences enhance the quality, utility, and clarity Agency Cost Report; Use: Providers of
with the care, as well as information on of the information to be collected; and Services participating in the Medicare
any potential health consequences due (4) the use of automated collection program are required under sections
to changes in IG medication or techniques or other forms of information 1815(a), 1833(e) and1861(v)(1)(A) of the
participation in the Demonstration. technology to minimize the information Social Security Act (42 U.S.C. 1395g) to
Lastly, we will gather the physicians collection burden. submit annual information to achieve
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Document Created: 2016-02-10 00:19:08
Document Modified: 2016-02-10 00:19:08
| 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 | |
| Action | Notice. | |
| Dates | Comments must be received by April 11, 2016: | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 7124 |
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