Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys, 51449-51450 [2020-18244]
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
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 drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug 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 drug 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 drug product, VYLEESI
(bremelanotide), which is indicated for
the treatment of premenopausal women
with acquired, generalized hypoactive
sexual desire disorder (HSDD) as
characterized by low sexual desire that
causes marked distress or interpersonal
difficulty and is not due to a co-existing
medical or psychiatric condition,
problems with the relationship, or the
effects of a medication or drug
substance. The product is not indicated
for treatment of HSDD in
postmenopausal women or in men and
is not indicated to enhance sexual
performance. Subsequent to this
approval, the USPTO received a patent
term restoration application for
VYLEESI (U.S. Patent Nos. 6,579,968
and 6,794,489) from Palatin
Technologies, Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
January 21, 2020, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
VYLEESI represented the first permitted
commercial marketing or use of the
product. Thereafter, the 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
VYLEESI is 6,721 days. Of this time,
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18:01 Aug 19, 2020
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6,265 days occurred during the testing
phase of the regulatory review period,
while 456 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 (FD&C Act) (21 U.S.C.
355(i)) became effective: January 27,
2001. The applicant claims March 13,
2002, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 27, 2001,
which was 30 days after FDA receipt of
the first IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 23, 2018.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
VYLEESI (NDA 210557) was initially
submitted on March 23, 2018.
3. The date the application was
approved: June 21, 2019. FDA has
verified the applicant’s claim that NDA
210557 was approved on June 21, 2019.
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 applications for patent extension,
this applicant seeks 1,826 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.
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
PO 00000
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51449
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18240 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6063]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Customer/Partner
Service Surveys
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by September
21, 2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0360. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10:00 a.m.–12:00 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20AUN1.SGM
20AUN1
51450
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
Customer/Partner Service Surveys
OMB Control Number 0910–0360—
Extension
Under section 1003 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the Agency.
Executive Order 12862, entitled ‘‘Setting
Customer Service Standard,’’ directs
Federal Agencies that ‘‘provide
significant services directly to the
public’’ to ‘‘survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.’’ FDA
is seeking extension of an existing OMB
clearance to conduct a series of surveys
to implement Executive Order 12862.
Participation in the surveys is
voluntary. This request covers
customer/partner service surveys of
regulated entities, such as food
processors; cosmetic, drug, biologic, and
medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, courtesy, and problem
resolution in the context of individual
programs.
FDA estimates conducting 15
customer/partner service surveys per
year, each requiring an average of 15
minutes for review and completion. We
estimate respondents to these surveys to
be between 100 and 20,000 customers.
Some of these surveys will be repeats of
earlier surveys for purposes of
monitoring customer/partner service
and developing long-term data.
Respondents to this collection of
information cover a broad range of
stakeholders who have specific
characteristics related to certain
products or services regulated by FDA.
In the Federal Register of January 21,
2020 (85 FR 3389), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of survey
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Mail, telephone, web-based .................................................
55,000
1
55,000
0.25 (15
minutes)
1 There
Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18244 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1206]
Electronic Study Data Submission;
Data Standards; Support and
Requirement Begin for Study Data
Tabulation Model Version 1.7
Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3;
Correction
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration,
HHS.
ACTION:
13,750
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Total hours
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of July 7, 2020. The document
SUMMARY:
VerDate Sep<11>2014
18:01 Aug 19, 2020
Jkt 250001
announced the dates that support and
requirement will begin for version 1.7 of
the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data
Tabulation Model (SDTM)
Implementation Guide (IG) 3.3, and for
version 2.1 of the Define-Extensible
Markup Language (Define-XML). The
document provided the incorrect dates
for these electronic study data
standards. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 7, 2020 (85 FR
40658), in FR Doc. 2020–14512, the
following correction is made:
On page 40659, in the first column,
the last three sentences of the document
are corrected to read as follows:
‘‘Support for version 1.7 of the CDISC
SDTM IG 3.3 and version 2.1 of the
Define-XML will begin on March 15,
2021, and the date that the requirement
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
begins for CDISC version 1.7 SDTM IG
3.3 and version 2.1 of the Define-XML
for new drug applications, abbreviated
new drug applications, certain biologics
license applications, and
noncommercial investigational new
drug applications will be March 15,
2022. Support and requirement for
version 1.3 of the CDISC SDTM IG 3.1.3
will end on March 15, 2021.’’
Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18236 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6098]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration-Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\20AUN1.SGM
Notice.
20AUN1
]]>Agencies
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51449-51450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18244]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-6063]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Customer/Partner
Service Surveys
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 21, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0360. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10:00 a.m.-12:00
p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 51450]]
Customer/Partner Service Surveys
OMB Control Number 0910-0360--Extension
Under section 1003 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 393), FDA is authorized to conduct research and public
information programs about regulated products and responsibilities of
the Agency. Executive Order 12862, entitled ``Setting Customer Service
Standard,'' directs Federal Agencies that ``provide significant
services directly to the public'' to ``survey customers to determine
the kind and quality of services they want and their level of
satisfaction with existing services.'' FDA is seeking extension of an
existing OMB clearance to conduct a series of surveys to implement
Executive Order 12862. Participation in the surveys is voluntary. This
request covers customer/partner service surveys of regulated entities,
such as food processors; cosmetic, drug, biologic, and medical device
manufacturers; consumers; and health professionals. The request also
covers ``partner'' (State and local governments) customer service
surveys.
FDA will use the information from these surveys to identify
strengths and weaknesses in service to customers/partners and to make
improvements. The surveys will measure timeliness, appropriateness and
accuracy of information, courtesy, and problem resolution in the
context of individual programs.
FDA estimates conducting 15 customer/partner service surveys per
year, each requiring an average of 15 minutes for review and
completion. We estimate respondents to these surveys to be between 100
and 20,000 customers. Some of these surveys will be repeats of earlier
surveys for purposes of monitoring customer/partner service and
developing long-term data.
Respondents to this collection of information cover a broad range
of stakeholders who have specific characteristics related to certain
products or services regulated by FDA.
In the Federal Register of January 21, 2020 (85 FR 3389), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of survey Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mail, telephone, web-based......................................... 55,000 1 55,000 0.25 (15 13,750
minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18244 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P
