83 FR 13130 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 59 (March 27, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 59 (March 27, 2018)
| Page Range | 13130-13132 | |
| FR Document | 2018-06081 |
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)] [Notices] [Pages 13130-13132] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06081] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10341, CMS-10538, CMS-R-153, CMS-10561 and CMS-10336] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services. 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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by May 29, 2018. 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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 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: William Parham at (410) 786-4669. 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-10341 Affordable Care Act Information and Collection Requirements for Section 1115 Demonstration Projects CMS-10538 Hospice Information for Medicare Part D Plans CMS-R-153 Medicaid Drug Use Review (DUR) Program CMS-10561 Essential Community Provider Data Collection to Support QHP Certification for PYs 2021-2023 CMS-10336 Medicare and Medicaid Programs; Electronic Health Record Incentive Program Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management 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. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Section 1115 Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428; Use: This collection is necessary to ensure that states comply with regulatory and statutory requirements related to the development, implementation and evaluation of demonstration projects. States seeking waiver authority under Section 1115 are required to meet certain requirements for public notice, the evaluation of demonstration projects, and reports to the Secretary on the implementation of approved demonstrations. Form Number: CMS-10341 (OMB control number 0938-1162); Frequency: Yearly and quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 37; Total Annual Responses: 300; Total Annual Hours: 24,092. (For policy questions regarding this collection contact Tonya Moore at 410-786-0019.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Hospice Information for Medicare Part D Plans; Use: The form would be completed by the prescriber or the beneficiary's hospice, or if the prescriber or hospice provides the information verbally to the Part D sponsor, the form would be completed by the sponsor. Information provided on the form would be used by the Part D sponsor to establish coverage of the drug under Medicare Part D. Per statute, drugs that are necessary for the palliation and management of the terminal illness and related conditions are not eligible for payment under Part D. The standard form provides a vehicle for the hospice provider, prescriber or sponsor to document that the drug prescribed is ``unrelated'' to the [[Page 13131]] terminal illness and related conditions. It also gives a hospice organization the option to communicate a beneficiary's change in hospice status and care plan to Part D sponsors. Form Number: CMS-10538 (OMB control number 0938-1269); Frequency: Occasionally; Affected Public: Private sector (business or other for-profits); Number of Respondents: 424; Total Annual Responses: 376,487; Total Annual Hours: 31,374. (For policy questions regarding this collection contact Shelly Winston at 410-786-3694.) 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Use Review (DUR) Program; Use: States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient's name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist's comments relevant to the individual's drug therapy. The State must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact. Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States' DUR programs. The information submitted by States is reviewed and results are compiled by CMS in a format intended to provide information, comparisons and trends related to States' experiences with DUR. The States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 663; Total Annual Hours: 41,004. (For policy questions regarding this collection contact Emeka Egwim at 410-786-1092.) 4. Type of Information Collection Request: Extension of a currently approved information collection; Title of Information Collection: Essential Community Provider Data Collection to Support QHP Certification for PYs 2021-2023; Use: For plan years beginning on or after January 1, 2021, Health and Human Services (HHS) intends to continue collecting more complete provider data for inclusion on the HHS Essential Community Provider (ECP) list to ensure a more accurate reflection of the universe of qualified available ECPs in a given service area that can be counted toward an issuer's satisfaction of the ECP standard. HHS intends to continue collecting these data on qualified and available ECPs directly from providers through the online ECP petition. Providers will submit an ECP petition to be added to the HHS ECP list or update required data fields to remain on the list. Form Number: CMS-10561 (OMB Control Number: 0938-1295); Frequency: Annually; Affected Public: Private sector (Business or other for-profits and Not- for-profit Institutions); Number of Respondents: 14,260; Total Annual Responses: 14,260; Total Annual Hours: 7,468. (For policy questions regarding this collection contact Deborah Hunter at (202) 309-1098). 5. Type of Information Collection Request: Extension of a currently approved information collection; Title of Information Collection: Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Use: The American Recovery and Reinvestment Act of 2009 (Recovery Act) (Pub. L. 111-5) was enacted on February 17, 2009. The Recovery Act includes many measures to modernize our nation's infrastructure, and improve affordable health care. Expanded use of health information technology (HIT) and certified electronic health record (EHR) technology will improve the quality and value of America's health care. Title IV of Division B of the Recovery Act amends Titles XVIII and XIX of the Social Security Act (the Act) by establishing incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs), and Medicare Advantage (MA) organizations participating in the Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of certified EHR technology. These Recovery Act provisions, together with Title XIII of Division A of the Recovery Act, may be cited as the ``Health Information Technology for Economic and Clinical Health Act'' or the ``HITECH Act.'' The HITECH Act creates incentive programs for EPs and eligible hospitals, including CAHs, in the Medicare Fee-for-Service (FFS), MA, and Medicaid programs that successfully demonstrate meaningful use of certified EHR technology. In their first payment year, Medicaid EPs and eligible hospitals may adopt, implement or upgrade to certified EHR technology. It also, provides for payment adjustments in the Medicare FFS and MA programs starting in FY 2015 for EPs and eligible hospitals participating in Medicare that are not meaningful users of certified EHR technology. These payment adjustments do not pertain to Medicaid providers. The first final rule for the Medicare and Medicaid EHR Incentive Program, which was published in the Federal Register on July 28, 2010 (CMS-0033-F), specified the initial criteria EPs, eligible hospitals and CAHs, and MA organizations must meet in order to qualify for incentive payments; calculation of incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs, eligible hospitals and CAHs failing to demonstrate meaningful use of certified EHR technology beginning in 2015; and other program participation requirements. On the same date, the Office of the National Coordinator of Health Information Technology (ONC) issued a closely related final rule (45 CFR part 170, RIN 0991-AB58) that specified the initial set of standards, implementation specifications, and certification criteria for certified EHR technology. ONC has also issued a separate final rule on the establishment of certification programs for health information technology (HIT) (45 CFR part 170, RIN 0991-AB59). The functionality of certified EHR technology should facilitate the implementation of meaningful use. Subsequently, final rules have been issued by CMS (77 FR 53968) and ONC (77 FR 72985) to create a Stage 2 of meaningful use criteria and other changes to the CMS EHR Incentive Programs and the 2014 Edition Certification Criteria for EHR technology. The information collection requirements contained in this information collection request are needed to implement the HITECH Act. In order to avoid duplicate payments, all EPs are enumerated through their National Provider Identifier (NPI), while all eligible hospitals and CAHs are [[Page 13132]] enumerated through their CMS Certification Number (CCN). State Medicaid agencies and CMS use the provider's tax identification number and NPI or CCN combination in order to make payment, validate payment eligibility and detect and prevent duplicate payments for EPs, eligible hospitals and CAHs. Form Number: CMS-10336 (OMB Control Number: 0938- 1158); Frequency: Occasionally; Affected Public: Private sector; Number of Respondents: 214,694; Total Annual Responses: 214,694; Total Annual Hours: 2,034,740. (For policy questions regarding this collection contact Steven Johnson at (410) 786-3332). Dated: March 22, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-06081 Filed 3-26-18; 8:45 am] BILLING CODE 4120-01-P
![13130 Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
should sunset, or whether the limited OMB control number. To be assured information they conduct or sponsor.
wraparound pilot program should be consideration, comments and The term ‘‘collection of information’’ is
made permanent. Form Number: CMS– recommendations must be submitted in defined in 44 U.S.C. 3502(3) and 5 CFR
10571 (OMB control number: 0938– any one of the following ways: 1320.3(c) and includes agency requests
NEW); Frequency: Once; Affected 1. Electronically. You may send your or requirements that members of the
Public: Private Sector; Number of comments electronically to http:// public submit reports, keep records, or
Respondents: 8; Total Annual www.regulations.gov. Follow the provide information to a third party.
Responses: 8; Total Annual Hours: 24. instructions for ‘‘Comment or Section 3506(c)(2)(A) of the PRA
(For policy questions regarding this Submission’’ or ‘‘More Search Options’’ requires federal agencies to publish a
collection contact Usree to find the information collection 60-day notice in the Federal Register
Bandyopadhyay at 410–786–6650.) document(s) that are accepting concerning each proposed collection of
Dated: March 22, 2018. comments. information, including each proposed
2. By regular mail. You may mail extension or reinstatement of an existing
William N. Parham, III,
written comments to the following collection of information, before
Director, Paperwork Reduction Staff, Office submitting the collection to OMB for
of Strategic Operations and Regulatory
address: CMS, Office of Strategic
Operations and Regulatory Affairs, approval. To comply with this
Affairs.
Division of Regulations Development, requirement, CMS is publishing this
[FR Doc. 2018–06082 Filed 3–26–18; 8:45 am]
Attention: Document Identifier/OMB notice.
BILLING CODE 4120–01–P
Control Number ll, Room C4–26–05, Information Collection
7500 Security Boulevard, Baltimore,
Maryland 21244–1850. 1. Type of Information Collection
DEPARTMENT OF HEALTH AND Request: Extension of a currently
HUMAN SERVICES To obtain copies of a supporting
statement and any related forms for the approved collection; Title of
proposed collection(s) summarized in Information Collection: Section 1115
Centers for Medicare & Medicaid
this notice, you may make your request Demonstration Projects Regulations at
Services 42 CFR 431.408, 431.412, 431.420,
using one of following:
[Document Identifiers: CMS–10341, CMS– 1. Access CMS’ website address at 431.424, and 431.428; Use: This
10538, CMS–R–153, CMS–10561 and CMS– https://www.cms.gov/Regulations-and- collection is necessary to ensure that
10336]
Guidance/Legislation/ states comply with regulatory and
PaperworkReductionActof1995/PRA- statutory requirements related to the
Agency Information Collection development, implementation and
Activities: Proposed Collection; Listing.html.
2. Email your request, including your evaluation of demonstration projects.
Comment Request States seeking waiver authority under
address, phone number, OMB number,
AGENCY: Centers for Medicare & and CMS document identifier, to Section 1115 are required to meet
Medicaid Services. Paperwork@cms.hhs.gov. certain requirements for public notice,
3. Call the Reports Clearance Office at the evaluation of demonstration
ACTION: Notice.
(410) 786–1326. projects, and reports to the Secretary on
SUMMARY: The Centers for Medicare & the implementation of approved
FOR FURTHER INFORMATION CONTACT:
Medicaid Services (CMS) is announcing demonstrations. Form Number: CMS–
William Parham at (410) 786–4669. 10341 (OMB control number 0938–
an opportunity for the public to SUPPLEMENTARY INFORMATION:
comment on CMS’ intention to collect 1162); Frequency: Yearly and quarterly;
information from the public. Under the Contents Affected Public: State, Local, or Tribal
Paperwork Reduction Act of 1995 (the Governments; Number of Respondents:
This notice sets out a summary of the 37; Total Annual Responses: 300; Total
PRA), federal agencies are required to use and burden associated with the
publish notice in the Federal Register Annual Hours: 24,092. (For policy
following information collections. More questions regarding this collection
concerning each proposed collection of detailed information can be found in
information (including each proposed contact Tonya Moore at 410–786–0019.)
each collection’s supporting statement 2. Type of Information Collection
extension or reinstatement of an existing and associated materials (see Request: Extension of a currently
collection of information) and to allow ADDRESSES). approved collection; Title of
60 days for public comment on the CMS–10341 Affordable Care Act Information Collection: Hospice
proposed action. Interested persons are Information and Collection Information for Medicare Part D Plans;
invited to send comments regarding our Requirements for Section 1115 Use: The form would be completed by
burden estimates or any other aspect of Demonstration Projects the prescriber or the beneficiary’s
this collection of information, including CMS–10538 Hospice Information for hospice, or if the prescriber or hospice
the necessity and utility of the proposed Medicare Part D Plans provides the information verbally to the
information collection for the proper CMS–R–153 Medicaid Drug Use Part D sponsor, the form would be
performance of the agency’s functions, Review (DUR) Program completed by the sponsor. Information
the accuracy of the estimated burden, CMS–10561 Essential Community provided on the form would be used by
ways to enhance the quality, utility, and Provider Data Collection to Support the Part D sponsor to establish coverage
clarity of the information to be QHP Certification for PYs 2021– of the drug under Medicare Part D. Per
collected, and the use of automated 2023 statute, drugs that are necessary for the
collection techniques or other forms of
amozie on DSK30RV082PROD with NOTICES
CMS–10336 Medicare and Medicaid palliation and management of the
information technology to minimize the Programs; Electronic Health Record terminal illness and related conditions
information collection burden. Incentive Program are not eligible for payment under Part
DATES: Comments must be received by Under the PRA (44 U.S.C. 3501– D. The standard form provides a vehicle
May 29, 2018. 3520), federal agencies must obtain for the hospice provider, prescriber or
ADDRESSES: When commenting, please approval from the Office of Management sponsor to document that the drug
reference the document identifier or and Budget (OMB) for each collection of prescribed is ‘‘unrelated’’ to the
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enumerated through their CMS FOR FURTHER INFORMATION CONTACT: respondents rely to bring information to
Certification Number (CCN). State Domini Bean, Office of Operations, FDA regarding the development of foods
Medicaid agencies and CMS use the Food and Drug Administration, Three derived from new plant varieties. All
provider’s tax identification number and White Flint North, 10A–12M, 11601 the more reason, the comments said,
NPI or CCN combination in order to Landsdown St., North Bethesda, MD FDA should identify mechanisms by
make payment, validate payment 20852, 301–796–5733, PRAStaff@ which it can better incorporate its
eligibility and detect and prevent fda.hhs.gov. experience over time and, where
duplicate payments for EPs, eligible SUPPLEMENTARY INFORMATION: In possible, implement more efficient,
hospitals and CAHs. Form Number: compliance with 44 U.S.C. 3507, FDA streamlined review processes for those
CMS–10336 (OMB Control Number: has submitted the following proposed products similar to those the Agency
0938–1158); Frequency: Occasionally; collection of information to OMB for has reviewed in the past. The comments
Affected Public: Private sector; Number review and clearance. recommended FDA compare efficiencies
of Respondents: 214,694; Total Annual with a process at the U.S. Department of
Responses: 214,694; Total Annual Guidance on Consultation Procedures:
Foods Derived From New Plant Agriculture regarding the review of
Hours: 2,034,740. (For policy questions agricultural biotechnology products. We
regarding this collection contact Steven Varieties
appreciate this suggestion. FDA strives
Johnson at (410) 786–3332). OMB Control Number 0910–0704— to allocate its limited resources in ways
Dated: March 22, 2018. Extension that maximize protection to the public
William N. Parham, III, This information collection supports health and facilitate compliance with
Director, Paperwork Reduction Staff, Office the above captioned Agency guidance existing regulatory requirements
of Strategic Operations and Regulatory document. FDA recommends that implemented to do so. We also look for
Affairs. producers who use biotechnology in the ways in which we might coordinate our
[FR Doc. 2018–06081 Filed 3–26–18; 8:45 am] manufacture or development of foods efforts with those by other agencies who
BILLING CODE 4120–01–P and food ingredients work cooperatively share these objectives.
with FDA to ensure that products Both comments also included the
derived through biotechnology are safe suggestion that FDA develop a less
DEPARTMENT OF HEALTH AND and comply with all applicable legal redundant review process (such as
HUMAN SERVICES requirements and has instituted a reciprocity if no material differences are
voluntary consultation process with
Food and Drug Administration identified) that better coordinates
industry. To facilitate this process the
expertise across the Center for Food
Agency has issued a guidance entitled,
[Docket No. FDA–2010–D–0073] Safety and Nutrition (CFSAN) and the
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant Center for Veterinary Medicine (CVM)
Agency Information Collection Varieties,’’ which is available on our into a single, efficient review. We
Activities; Submission for Office of website at https://www.fda.gov/ appreciate this suggestion as well and,
Management and Budget Review; FoodGuidances. The guidance describes as discussed in the guidance, note the
Comment Request; Guidance on FDA’s consultation process for the following:
Consultation Procedures: Foods evaluation of information on new plant [FDA’s] Office of Premarket Approval
Derived From New Plant Varieties varieties provided by developers. The of the CFSAN and the Office of
AGENCY: Food and Drug Administration, Agency believes this consultation Surveillance and Compliance of the
HHS. process will help ensure that human CVM have established a Biotechnology
ACTION: Notice. food and animal feed safety issues or Evaluation Team (BET) to facilitate, and
other regulatory issues (e.g., labeling) to ensure consistency in the process by
SUMMARY: The Food and Drug are resolved prior to commercial which firms consult under the 1992
Administration (FDA) is announcing distribution. Additionally, such policy and inform FDA regarding the
that a proposed collection of communication will help to ensure that marketing of bioengineered foods and
information has been submitted to the any potential food safety issues food ingredients derived from new plant
Office of Management and Budget regarding a new plant variety are varieties including those developed
(OMB) for review and clearance under resolved during development, and will using rDNA techniques. The BET
the Paperwork Reduction Act of 1995 help to ensure that all market entry oversees the consultation process,
(PRA). decisions by the industry are made identifies regulatory and scientific
consistently and in full compliance with issues that need to be addressed, and
DATES: Fax written comments on the
the standards of the Federal Food, Drug, once all relevant issues have been
collection of information by April 26,
and Cosmetic Act (FD&C Act). adequately addressed, brings the
2018. In the Federal Register of December consultation to closure.
ADDRESSES: To ensure that comments on 13, 2017 (82 FR 58619), we published a
the information collection are received, 60-day notice requesting public At the same time, we have shared the
OMB recommends that written comment on the proposed extension of comments received in response to this
comments be faxed to the Office of this collection of information. Two notice under the PRA with the BET.
Information and Regulatory Affairs, comments were received in response to Consistent with our Good Guidance
OMB, Attn: FDA Desk Officer, Fax: 202– the notice. Overall, the comments Practice regulations (21 CFR 10.115),
FDA welcomes comments on our
amozie on DSK30RV082PROD with NOTICES
395–7285, or emailed to oira_ supported FDA’s need for the
submission@omb.eop.gov. All information collection and neither guidance documents at any time.
comments should be identified with the comment suggested revising our In consideration of these comments,
OMB control number 0910–0704. Also estimate of the associated burden. we have retained the currently approved
include the FDA docket number found However, both comments reminded us burden estimated associated with the
in brackets in the heading of this that significant resources were invested information collection, which is as
document. into developing data upon which follows:
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Document Created: 2018-03-27 01:26:51
Document Modified: 2018-03-27 01:26:51
| 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 May 29, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 13130 |
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