Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: HRSA Ryan White HIV/AIDS Program AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-Revision, 66202-66203 [2019-26099]
Download as PDF
<![CDATA[
66202
Federal Register / Vol. 84, No. 232 / Tuesday, December 3, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
lotter on DSKBCFDHB2PROD with NOTICES
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product AIMOVIG
(erenumab-aooe). AIMOVIG is indicated
for the preventive treatment of migraine
in adults. Subsequent to this approval,
the USPTO received a patent term
restoration application for AIMOVIG
(U.S. Patent No. 9,102,731) from Amgen,
Inc., and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated May 13, 2019, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of AIMOVIG represented the
first permitted commercial marketing or
use of the product. Thereafter, the
VerDate Sep<11>2014
18:27 Dec 02, 2019
Jkt 250001
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
AIMOVIG is 2,042 days. Of this time,
1,675 days occurred during the testing
phase of the regulatory review period,
while 367 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: October 16, 2012. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
October 16, 2012.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 17, 2017. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
AIMOVIG (BLA 761077) was initially
submitted on May 17, 2017.
3. The date the application was
approved: May 17, 2018. FDA has
verified the applicant’s claim that BLA
761077 was approved on May 17, 2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 689 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26081 Filed 12–2–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: HRSA Ryan
White HIV/AIDS Program AIDS Drug
Assistance Program Data Report, OMB
No. 0915–0345—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 3, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, pursuant to Section
3506(c)(2)(A), the Paperwork Reduction
Act of 1995.
SUMMARY:
E:\FR\FM\03DEN1.SGM
03DEN1
66203
Federal Register / Vol. 84, No. 232 / Tuesday, December 3, 2019 / Notices
Information Collection Request Title:
HRSA Ryan White HIV/AIDS Program
(RWHAP) AIDS Drug Assistance
Program Data Report, OMB No. 0915–
0345—Revision.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) AIDS Drug
Assistance Program (ADAP) is
authorized under Part B of the RWHAP
legislation, codified in sections 2611 et
seq. of the Public Health Service Act,
which provides grants to U.S. states and
territories. RWHAP ADAP is a state and
territory-administered program that
provides Food and Drug Administration
approved medications to low-income
people with HIV who have limited or no
health coverage from private insurance,
Medicaid, or Medicare. RWHAP ADAP
funds may also be used to purchase
health insurance for eligible clients and
for services that enhance access,
adherence, and monitoring of drug
treatments.
All 50 states, the District of Columbia,
Puerto Rico, Guam, the U.S. Virgin
Islands, and the five U.S. Pacific
Territories or Associated Jurisdictions
receive RWHAP Part B grant awards
including funds for RWHAP ADAP.
RWHAP Part B reporting requirements
include the annual submission of an
ADAP Data Report (ADR), including a
Recipient Report and a Client Report.
The Recipient Report is a collection of
basic information about grant recipient
characteristics and policies including
program administration, purchasing
mechanisms, funding, and
expenditures. The Client Report is a
collection of client-level records (one
record for each client enrolled in the
RWHAP ADAP), which includes the
client’s encrypted unique identifier,
basic demographic data, enrollment
information, services received and
clinical data.
HRSA is proposing several changes to
the ADR Recipient and Client Reports to
improve question clarity, delete obsolete
data elements, combine related data
elements, add new data elements, and
improve response options to reflect
program practices and support HRSA’s
analysis and understanding of program
impact. Specifically, the Recipient
Report includes the following proposed
changes:
• Addition of two new ‘‘Yes/No’’
questions,
• addition of one new follow-up
question that requests the number of
new clients enrolled,
• clarification on two existing
questions,
• revision to one existing question
that requests program income and
manufacturer rebates reinvested in
ADAP, and
• deletion of six obsolete data
elements.
The Client Report includes the
following proposed changes:
• Revision to reporting of RWHAP
ADAP-funded medications to include
all medications rather than a subset of
medications;
• revision to one existing question
that requests reporting of all RWHAP
ADAP-funded medications using the
National Drug Code from the Drug
Identification Code (d-codes);
• revision to reporting of clinical data
for clients to include all clients rather
than a subset of clients; and
• deletion of three data elements that
were combined with other existing data
elements.
Overall, HRSA does not anticipate
these proposed revisions resulting in a
change in the reporting burden. New
and revised data elements require
reporting of information that should
already be collected by recipients to
meet legislative or programmatic
requirements for the proper oversight
and administration of the program.
Need and Proposed Use of the
Information: RWHAP requires the
submission of annual reports by the
Secretary of HHS to the appropriate
committees of Congress. HRSA uses the
ADR to evaluate the national impact of
the RWHAP ADAP by providing clientlevel data on individuals being served,
services being delivered, and costs
associated with these services. The
client-level data is used to monitor
health outcomes of people with HIV
receiving care and treatment through the
RWHAP ADAP, to monitor the use of
RWHAP ADAP funds in addressing the
HIV epidemic and its impact on
vulnerable communities, and to track
progress toward achieving the goals
identified in the National HIV/AIDS
Strategy.
Likely Respondents: State ADAPs of
RWHAP Part B recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOUR
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Grantee Report ....................................................................
Client-level Report ...............................................................
54
54
1
1
54
54
6
81
324
4,374
Total ..............................................................................
* 54
........................
54
........................
4,698
lotter on DSKBCFDHB2PROD with NOTICES
* The same respondents complete the Grantee Report and the Client-level Report.
HRSA specifically requests comments
on (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
VerDate Sep<11>2014
18:27 Dec 02, 2019
Jkt 250001
use of automated collection techniques
or other forms of information
PO 00000
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–26099 Filed 12–2–19; 8:45 am]
BILLING CODE 4165–15–P
Frm 00058
Fmt 4703
Sfmt 4703
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 84, Number 232 (Tuesday, December 3, 2019)]
[Notices]
[Pages 66202-66203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26099]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: HRSA Ryan
White HIV/AIDS Program AIDS Drug Assistance Program Data Report, OMB
No. 0915-0345--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than February
3, 2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference, pursuant to Section 3506(c)(2)(A), the Paperwork
Reduction Act of 1995.
[[Page 66203]]
Information Collection Request Title: HRSA Ryan White HIV/AIDS
Program (RWHAP) AIDS Drug Assistance Program Data Report, OMB No. 0915-
0345--Revision.
Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) AIDS Drug
Assistance Program (ADAP) is authorized under Part B of the RWHAP
legislation, codified in sections 2611 et seq. of the Public Health
Service Act, which provides grants to U.S. states and territories.
RWHAP ADAP is a state and territory-administered program that provides
Food and Drug Administration approved medications to low-income people
with HIV who have limited or no health coverage from private insurance,
Medicaid, or Medicare. RWHAP ADAP funds may also be used to purchase
health insurance for eligible clients and for services that enhance
access, adherence, and monitoring of drug treatments.
All 50 states, the District of Columbia, Puerto Rico, Guam, the
U.S. Virgin Islands, and the five U.S. Pacific Territories or
Associated Jurisdictions receive RWHAP Part B grant awards including
funds for RWHAP ADAP. RWHAP Part B reporting requirements include the
annual submission of an ADAP Data Report (ADR), including a Recipient
Report and a Client Report. The Recipient Report is a collection of
basic information about grant recipient characteristics and policies
including program administration, purchasing mechanisms, funding, and
expenditures. The Client Report is a collection of client-level records
(one record for each client enrolled in the RWHAP ADAP), which includes
the client's encrypted unique identifier, basic demographic data,
enrollment information, services received and clinical data.
HRSA is proposing several changes to the ADR Recipient and Client
Reports to improve question clarity, delete obsolete data elements,
combine related data elements, add new data elements, and improve
response options to reflect program practices and support HRSA's
analysis and understanding of program impact. Specifically, the
Recipient Report includes the following proposed changes:
Addition of two new ``Yes/No'' questions,
addition of one new follow-up question that requests the
number of new clients enrolled,
clarification on two existing questions,
revision to one existing question that requests program
income and manufacturer rebates reinvested in ADAP, and
deletion of six obsolete data elements.
The Client Report includes the following proposed changes:
Revision to reporting of RWHAP ADAP-funded medications to
include all medications rather than a subset of medications;
revision to one existing question that requests reporting
of all RWHAP ADAP-funded medications using the National Drug Code from
the Drug Identification Code (d-codes);
revision to reporting of clinical data for clients to
include all clients rather than a subset of clients; and
deletion of three data elements that were combined with
other existing data elements.
Overall, HRSA does not anticipate these proposed revisions
resulting in a change in the reporting burden. New and revised data
elements require reporting of information that should already be
collected by recipients to meet legislative or programmatic
requirements for the proper oversight and administration of the
program.
Need and Proposed Use of the Information: RWHAP requires the
submission of annual reports by the Secretary of HHS to the appropriate
committees of Congress. HRSA uses the ADR to evaluate the national
impact of the RWHAP ADAP by providing client-level data on individuals
being served, services being delivered, and costs associated with these
services. The client-level data is used to monitor health outcomes of
people with HIV receiving care and treatment through the RWHAP ADAP, to
monitor the use of RWHAP ADAP funds in addressing the HIV epidemic and
its impact on vulnerable communities, and to track progress toward
achieving the goals identified in the National HIV/AIDS Strategy.
Likely Respondents: State ADAPs of RWHAP Part B recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hour
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 54 1 54 6 324
Client-level Report............. 54 1 54 81 4,374
-------------------------------------------------------------------------------
Total....................... * 54 .............. 54 .............. 4,698
----------------------------------------------------------------------------------------------------------------
* The same respondents complete the Grantee Report and the Client-level Report.
HRSA specifically requests comments on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-26099 Filed 12-2-19; 8:45 am]
BILLING CODE 4165-15-P
