Request for Information: Ensuring Patient Access and Effective Drug Enforcement, 36111-36112 [2019-15952]
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Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices
Programs, Healthcare Systems Bureau,
5600 Fishers Lane, 08N146B, Rockville,
Maryland 20857. The Court’s caption
(Petitioner’s Name v. Secretary of HHS)
and the docket number assigned to the
petition should be used as the caption
for the written submission. Chapter 35
of title 44, United States Code, related
to paperwork reduction, does not apply
to information required for purposes of
carrying out the Program.
Dated: July 18, 2019.
George Sigounas,
Administrator.
jbell on DSK3GLQ082PROD with NOTICES
List of Petitions Filed
1. Gary Radford, Washington, District of
Columbia, Court of Federal Claims No:
19–0808V
2. Yong Yu, Flushing, New York, Court of
Federal Claims No: 19–0809V
3. Robert Nocille, Sewell, New Jersey, Court
of Federal Claims No: 19–0810V
4. Todd Garrison, Lewisburg, Pennsylvania,
Court of Federal Claims No: 19–0811V
5. Victoria Marcus, Rockville, Maryland,
Court of Federal Claims No: 19–0812V
6. Patricia McDorman, Bowie, Maryland,
Court of Federal Claims No: 19–0814V
7. Stephen Winkelstein, Washington, District
of Columbia, Court of Federal Claims No:
19–0815V
8. Jennifer Longo, Morrisville, North
Carolina, Court of Federal Claims No:
19–0816V
9. Judy Bell, Madison, Florida, Court of
Federal Claims No: 19–0817V
10. Ana Margarita Flores, Norwalk,
California, Court of Federal Claims No:
19–0818V
11. Jean Draper, Rio Rancho, New Mexico,
Court of Federal Claims No: 19–0819V
12. Ross Davenport, Spokane, Washington,
Court of Federal Claims No: 19–0820V
13. Julian Paul, Louisville, Kentucky, Court
of Federal Claims No: 19–0821V
14. Arati Katherine Johnston, Radnor,
Pennsylvania, Court of Federal Claims
No: 19–0822V
15. Michelle Maupin, Milroy, Indiana, Court
of Federal Claims No: 19–0823V
16. Charles Eastwood, Manchester, New
Hampshire, Court of Federal Claims No:
19–0824V
17. Lavada M. Hodd, Hayward, Wisconsin,
Court of Federal Claims No: 19–0828V
18. Mary Clausen, Cape Coral, Florida, Court
of Federal Claims No: 19–0829V
19. Daniel Joseph Martin, Elkhart, Indiana,
Court of Federal Claims No: 19–0830V
20. Lyudmila Dutil, South Riding, Virginia,
Court of Federal Claims No: 19–0831V
21. Ashlee Rodriguez, Boston, Massachusetts,
Court of Federal Claims No: 19–0832V
22. Warren Lathan, Chicago, Illinois, Court of
Federal Claims No: 19–0833V
23. Anita Gross, Yankton, South Dakota,
Court of Federal Claims No: 19–0835V
24. Janet Yanchak Holick, Tucson, Arizona,
Court of Federal Claims No: 19–0838V
25. Leonel Sanchez, Houston, Texas, Court of
Federal Claims No: 19–0840V
26. Crystal Shuhart, Greenville, South
Carolina, Court of Federal Claims No:
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19–0842V
27. Marlene Gallichan, Seattle, Washington,
Court of Federal Claims No: 19–0845V
28. Bruce Yoch, Pittsburgh, Pennsylvania,
Court of Federal Claims No: 19–0849V
29. Michael J. McFall, Corning, New York,
Court of Federal Claims No: 19–0850V
30. Sanela Nicocevic on behalf of S.R.,
Stamford, Connecticut, Court of Federal
Claims No: 19–0853V
31. Anita McDonald, Philadelphia,
Pennsylvania, Court of Federal Claims
No: 19–0855V
32. Betty Myers-Noble, Los Angeles,
California, Court of Federal Claims No:
19–0856V
33. Michaelene Widson, Reno, Nevada, Court
of Federal Claims No: 19–0858V
34. Ralph L. Lamacchia, Milwaukee,
Wisconsin, Court of Federal Claims No:
19–0860V
35. Debra Hatchett, Lake Forest, Illinois,
Court of Federal Claims No: 19–0861V
36. Maria Carrillo, Chicago, Illinois, Court of
Federal Claims No: 19–0862V
37. Douglas Sandhofer, Timonium,
Maryland, Court of Federal Claims No:
19–0863V
38. Tammee Hinton, Winter Garden, Florida,
Court of Federal Claims No: 19–0866V
39. David Glassman, M.D., Phoenix, Arizona,
Court of Federal Claims No: 19–0867V
40. Lamise Al-Basha, Rockford, Illinois,
Court of Federal Claims No: 19–0869V
41. Hannah Davis, Charlevoix, Michigan,
Court of Federal Claims No: 19–0871V
42. Meagan Sevier, Andover, Kansas, Court of
Federal Claims No: 19–0872V
43. Rachel Clemmer, Takoma Park,
Maryland, Court of Federal Claims No:
19–0878V
44. Timothy Andrews, Memphis, Tennessee,
Court of Federal Claims No: 19–0879V
45. Virginio Trevisan on behalf of Victoria
Leonor Trevisan, Torrance, California,
Court of Federal Claims No: 19–0880V
46. Antonio Illiano, Hampton, New Jersey,
Court of Federal Claims No: 19–0884V
47. Olivia D. Thompson, Richmond, Virginia,
Court of Federal Claims No: 19–0887V
48. George Youhana and Belina Youhana on
behalf of C.Y.Y., Los Gatos, California,
Court of Federal Claims No: 19–0888V
49. Linda Modderman, Spokane,
Washington, Court of Federal Claims No:
19–0890V
50. Matthew Thompson, Belleville,
Michigan, Court of Federal Claims No:
19–0891V
51. Autumn Morgan, East Stroudsburg,
Pennsylvania, Court of Federal Claims
No: 19–0893V
52. Norma Blair, Bourbonnais, Illinois, Court
of Federal Claims No: 19–0894V
53. Maxfel Goodson, Vancouver, Washington,
Court of Federal Claims No: 19–0895V
54. Michael Ball, Boone, North Carolina,
Court of Federal Claims No: 19–0896V
55. Anthony Stefano, Newport Beach,
California, Court of Federal Claims No:
19–0898V
56. Kelly Bennett, Cincinnati, Ohio, Court of
Federal Claims No: 19–0902V
57. Brad Bundesen, Washington, District of
Columbia, Court of Federal Claims No:
19–0903V
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58. Dana Sherrod, Carrollton, Texas, Court of
Federal Claims No: 19–0906V
59. Rhonda O’Brien, Washington, District of
Columbia, Court of Federal Claims No:
19–0909V
60. Adriana Lopez, Boston, Massachusetts,
Court of Federal Claims No: 19–0910V
61. Christina Witham, Gahanna, Ohio, Court
of Federal Claims No: 19–0912V
62. Jacqueline Venable, Washington, District
of Columbia, Court of Federal Claims No:
19–0913V
63. Kaminie Rampergash, Washington,
District of Columbia, Court of Federal
Claims No: 19–0914V
64. Jennifer Imm, Washington, District of
Columbia, Court of Federal Claims No:
19–0915V
65. Edward Zhao, Washington, District of
Columbia, Court of Federal Claims No:
19–0916V
66. Rosa Ortiz, Davenport, Iowa, Court of
Federal Claims No: 19–0917V
67. Laura Zalewski, Chicago, Illinois, Court
of Federal Claims No: 19–0918V
68. Angelena Walker, Bellefontaine, Ohio,
Court of Federal Claims No: 19–0919V
69. Anna Nasher, Dresher, Pennsylvania,
Court of Federal Claims No: 19–0920V
70. Lisa Simmons, Bellevue, Washington,
Court of Federal Claims No: 19–0924V
71. Tammie Walden, Gray, Georgia, Court of
Federal Claims No: 19–0927V
72. Abby L. Adams on behalf of Donald C.
Adams, Deceased, Linwood, New Jersey,
Court of Federal Claims No: 19–0929V
73. Melody Massi, Wayne, Pennsylvania,
Court of Federal Claims No: 19–0930V
74. Bridgett Runkles, Tinker Air Force Base,
Oklahoma, Court of Federal Claims No:
19–0934V
75. Judson Costlow, Richmond, Indiana,
Court of Federal Claims No: 19–0935V
76. Griselda Ruiz, Richmond, Virginia, Court
of Federal Claims No: 19–0936V
77. Virginia Carpanini, Hudson, New York,
Court of Federal Claims No: 19–0940V
78. Ralph F. Harper, Fernley, Nevada, Court
of Federal Claims No: 19–0941V
79. Sandra Lucchesi, Santa Rosa, California,
Court of Federal Claims No: 19–0943V
80. Leanne Roth, Carpinteria, California,
Court of Federal Claims No: 19–0944V
81. Gavin Beagley, American Fork, Utah,
Court of Federal Claims No: 19–0948V
[FR Doc. 2019–15910 Filed 7–25–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Request for Information: Ensuring
Patient Access and Effective Drug
Enforcement
Office of the Assistant
Secretary for Planning and Evaluation
(ASPE), HHS.
ACTION: Request for information.
AGENCY:
SUMMARY: This Request for Information
(RFI) seeks comment on ensuring
E:\FR\FM\26JYN1.SGM
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36112
Federal Register / Vol. 84, No. 144 / Friday, July 26, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
legitimate access to controlled
substances, including opioids, while
also preventing diversion and abuse, as
well as how federal, state, local, and
tribal entities can collaborate to address
these issues.
DATES: Comments must be received at
one of the addresses provided below, no
later than 5 p.m. on August 26, 2019.
ADDRESSES: Written comments can be
provided by email, fax or U.S. mail.
Email: EPAEDEAreport@hhs.gov.
Fax: (202) 690–5882.
Mail: U.S. Department of Health and
Human Services, Office of the Assistant
Secretary for Planning and Evaluation,
Office of Science and Data Policy, Attn:
EPAEDEA Report Feedback, 200
Independence Avenue SW, Room 434E,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Jessica White, Office of the Assistant
Secretary for Planning and Evaluation,
202–690–7100.
SUPPLEMENTARY INFORMATION:
I. Background
Section 3 of the Ensuring Patient
Access and Effective Drug Enforcement
Act of 2016 (EPAEDEA), Public Law
114–145, called for the Department of
Health and Human Services, acting
through the Commissioner of Food and
Drugs, the Administrator of the
Substance Abuse and Mental Health
Services Administration, the Director of
the Agency for Healthcare Research and
Quality, and the Director of the Centers
for Disease Control and Prevention, and
in coordination with the Administrator
of the Drug Enforcement Administration
and in consultation with the Secretary
of Defense and the Secretary of Veterans
Affairs, to submit a report to Congress
that identifies:
• Obstacles to legitimate patient access
to controlled substances
• issues with diversion of controlled
substances
• how collaboration between Federal,
State, local, and tribal law
enforcement agencies and the
pharmaceutical industry can benefit
patients and prevent diversion and
abuse of controlled substances;
• the availability of medical education,
training opportunities, and
comprehensive clinical guidance for
pain management and opioid
prescribing, and any gaps that should
be addressed
• beneficial enhancements to State
prescription drug monitoring
programs, including enhancements to
require comprehensive prescriber
input and to expand access to the
programs for appropriate authorized
users
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17:54 Jul 25, 2019
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• steps to improve reporting
requirements so that the public and
Congress have more information
regarding prescription opioids, such
as the volume and formulation of
prescription opioids prescribed
annually, the dispensing of such
prescription opioids, and outliers and
trends within large data sets.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
II. Solicitation of Comments
EPAEDEA requires that the report
incorporate feedback and
recommendations from the following:
(1) Patient groups; (2) pharmacies; (3)
drug manufacturers; (4) common or
contract carriers and warehousemen; (5)
hospitals, physicians, and other health
care providers; (6) State attorneys
general; (7) Federal, State, local, and
tribal law enforcement agencies; (8)
health insurance providers and entities
that provide pharmacy benefit
management services on behalf of a
health insurance provider; (9) wholesale
drug distributors; (10) veterinarians; (11)
professional medical societies and
boards; (12) State and local public
health authorities; and (13) health
services research organizations.
This RFI is seeking comment from
these stakeholders on the
aforementioned issue areas to be
covered by the report.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Review for: HEAL:
Optimization of Non-addictive Therapies
[Small Molecules and Biologics] to Treat
Pain.
Date: July 26, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Marilyn Moore-Hoon,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Activities, National Institute of Neurological
Disorders and Stroke, Bethesda, MD 20892,
301–827–9087, mooremar@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
III. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble.
Dated: July 16, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation (HSP).
[FR Doc. 2019–15952 Filed 7–25–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended.
Frm 00064
Fmt 4703
[FR Doc. 2019–15879 Filed 7–25–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Immigration and Customs
Enforcement
[OMB Control Number 1653–0043]
BILLING CODE 4150–15–P
PO 00000
Dated: July 19, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
Sfmt 4703
Agency Information Collection
Activities; Extension of a Currently
Approved Collection: Electronic Funds
Transfer Waiver Request; Comment
Request
U.S. Immigration and Customs
Enforcement, Department of Homeland
Security.
ACTION: 30-Day notice.
AGENCY:
SUMMARY: In accordance with the
Paperwork Reductions Act (PRA) of
1995 the Department of Homeland
Security (DHS), U.S. Immigration and
Customs Enforcement (ICE) will submit
the following Information Collection
Request (ICR) to the Office of
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]]>Agencies
[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36111-36112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15952]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Request for Information: Ensuring Patient Access and Effective
Drug Enforcement
AGENCY: Office of the Assistant Secretary for Planning and Evaluation
(ASPE), HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This Request for Information (RFI) seeks comment on ensuring
[[Page 36112]]
legitimate access to controlled substances, including opioids, while
also preventing diversion and abuse, as well as how federal, state,
local, and tribal entities can collaborate to address these issues.
DATES: Comments must be received at one of the addresses provided
below, no later than 5 p.m. on August 26, 2019.
ADDRESSES: Written comments can be provided by email, fax or U.S. mail.
Email: [email protected].
Fax: (202) 690-5882.
Mail: U.S. Department of Health and Human Services, Office of the
Assistant Secretary for Planning and Evaluation, Office of Science and
Data Policy, Attn: EPAEDEA Report Feedback, 200 Independence Avenue SW,
Room 434E, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Jessica White, Office of the Assistant
Secretary for Planning and Evaluation, 202-690-7100.
SUPPLEMENTARY INFORMATION:
I. Background
Section 3 of the Ensuring Patient Access and Effective Drug
Enforcement Act of 2016 (EPAEDEA), Public Law 114-145, called for the
Department of Health and Human Services, acting through the
Commissioner of Food and Drugs, the Administrator of the Substance
Abuse and Mental Health Services Administration, the Director of the
Agency for Healthcare Research and Quality, and the Director of the
Centers for Disease Control and Prevention, and in coordination with
the Administrator of the Drug Enforcement Administration and in
consultation with the Secretary of Defense and the Secretary of
Veterans Affairs, to submit a report to Congress that identifies:
Obstacles to legitimate patient access to controlled
substances
issues with diversion of controlled substances
how collaboration between Federal, State, local, and tribal
law enforcement agencies and the pharmaceutical industry can benefit
patients and prevent diversion and abuse of controlled substances;
the availability of medical education, training opportunities,
and comprehensive clinical guidance for pain management and opioid
prescribing, and any gaps that should be addressed
beneficial enhancements to State prescription drug monitoring
programs, including enhancements to require comprehensive prescriber
input and to expand access to the programs for appropriate authorized
users
steps to improve reporting requirements so that the public and
Congress have more information regarding prescription opioids, such as
the volume and formulation of prescription opioids prescribed annually,
the dispensing of such prescription opioids, and outliers and trends
within large data sets.
II. Solicitation of Comments
EPAEDEA requires that the report incorporate feedback and
recommendations from the following: (1) Patient groups; (2) pharmacies;
(3) drug manufacturers; (4) common or contract carriers and
warehousemen; (5) hospitals, physicians, and other health care
providers; (6) State attorneys general; (7) Federal, State, local, and
tribal law enforcement agencies; (8) health insurance providers and
entities that provide pharmacy benefit management services on behalf of
a health insurance provider; (9) wholesale drug distributors; (10)
veterinarians; (11) professional medical societies and boards; (12)
State and local public health authorities; and (13) health services
research organizations.
This RFI is seeking comment from these stakeholders on the
aforementioned issue areas to be covered by the report.
III. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble.
Dated: July 16, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and Evaluation (HSP).
[FR Doc. 2019-15952 Filed 7-25-19; 8:45 am]
BILLING CODE 4150-15-P
