Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 23969-23970 [2020-09170]
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Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
required by the court’s order, deemed
new tobacco products on the market as
of August 8, 2016, for which premarket
authorization applications are not filed
by May 12, 2020, are subject to FDA
enforcement actions, in the Agency’s
discretion. The court subsequently
clarified that its order did not restrict
FDA’s authority to enforce the
premarket review provisions against
deemed products, prior to May 12, 2020,
or during the 1-year review period.4 On
April 22, 2020, the court, upon FDA’s
motion, extended the premarket
application deadline set out in its order
by 120 days (until September 9, 2020)
in light of the global outbreak of
respiratory illness caused by a new
coronavirus.5
FDA is withdrawing the guidance
because the compliance deadlines
contained therein have passed, have
been vacated, or are stayed, with the
exception of those for reporting
requirements for harmful or potentially
harmful constituents (HPHC). FDA has
published and described these
deadlines in the Small Entity
Compliance Guide for the final deeming
rule; 6 they are also listed on the Center
for Tobacco Products’ HPHC website.7
Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09163 Filed 4–29–20; 8:45 am]
BILLING CODE 4164–01–P
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species—
21 CFR Part 516
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
OMB Control Number 0910–0620—
Extension
The Minor Use and Minor Species
Animal Health Act of 2004 (the MUMS
Act) (Pub. L. 108–282) added section
572 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360ccc–1), which authorizes FDA to
establish new regulatory procedures
intended to make more medications
legally available to veterinarians and
animal owners for the treatment of
minor animal species (species other
than cattle, horses, swine, chickens,
turkeys, dogs, and cats). In enacting the
MUMS Act, Congress sought to
encourage the development of these
new animal drugs. Congress recognized
that the markets for drugs intended to
treat these species are so small that
there are often insufficient economic
(PWG), Dkt. No. 154 (October 2, 2019). An appeal
is pending. See American Academy of Pediatrics v.
Cigar Ass’n of America, Nos. 19–2130, –2132,
–2198 (4th Cir.).
4 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., Case No. 8:18–cv–
883 (PWG), (D. Md. August 12, 2019), Dkt. No. 132.
5 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., Case No. 8:18–cv–
883 (PWG), (D. Md. April 22, 2020), Dkt. No. 182.
6 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/fda-deems-certaintobacco-products-subject-fda-authority-sales-anddistribution-restrictions-and.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
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 June 1,
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 0910–0620. 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, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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.
Notice.
VerDate Sep<11>2014
18:56 Apr 29, 2020
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Frm 00028
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23969
incentives to motivate drug companies
to develop data to support approvals.
Further, Congress recognized that some
minor species populations are too small
or their management systems too
diverse to make it practical to conduct
traditional studies to demonstrate safety
and effectiveness of animal drugs for
such uses.
As a result of these limitations, drug
companies have generally not been
willing or able to collect data to support
legal marketing of drugs for these
species. Consequently, Congress enacted
the MUMS Act to provide incentives to
develop new animal drugs for minor
species, while still ensuring appropriate
safeguards for animal and human
health. Section 572 of the FD&C Act
provides for a public index listing of
legally marketed unapproved new
animal drugs for minor species. FDA
regulations in part 516 (21 CFR part
516) specify, among other things, the
criteria and procedures for requesting
eligibility for indexing and for
requesting addition to the index, as well
as the annual reporting requirements for
index holders. The administrative
procedures and criteria for indexing a
new animal drug for use in a minor
species are set forth in §§ 516.111
through 516.171 (21 CFR 516.111
through 516.171). Section 516.165 sets
forth the annual reporting requirements
for index holders. FDA needs the
information to determine: (1) The
eligibility of a new animal drug for
indexing; (2) that a qualified expert
panel proposed to review certain
information regarding the new animal
drug meets the selection criteria listed
in the regulations; (3) whether the
Agency agrees with the
recommendation of a qualified expert
panel that a drug be added to the index;
and (4) whether there may be grounds
for removing a drug from the index.
In the Federal Register of January 7,
2020 (85 FR 714), we published a 60day notice requesting public comment
on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
7 For more information, please see https://
www.fda.gov/tobacco-products/productsingredients-components/harmful-and-potentiallyharmful-constituents-hphcs.
E:\FR\FM\30APN1.SGM
30APN1
23970
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
516.119; requires a foreign drug company to submit and
update the name and address of a permanent U.S. resident agent ........................................................................
516.121; written request for a meeting with FDA to discuss the requirements for indexing a new animal drug ...
516.123; written request for an informal conference and a
requestor’s written response to an FDA initial decision
denying a request .............................................................
516.125; correspondence and information associated with
investigational use of new animal drugs intended for indexing ...............................................................................
516.129; content and format of a request for determination
of eligibility for indexing ....................................................
516.141; information to be submitted to FDA by a requestor seeking to establish a qualified expert panel .....
516.143; content and format of the written report of the
qualified expert panel .......................................................
516.145; content and format of a request for addition to
the index ...........................................................................
516.161; content and format of a request for modification
of an indexed drug ...........................................................
516.163; information to be contained in a request to FDA
to transfer ownership of a drug’s index file to another
person ...............................................................................
516.165; requires drug experience reports and distributor
statements to be submitted to FDA .................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
5
1
5
1
5
30
2
60
4
240
3
1
3
8
24
2
3
6
20
120
30
2
60
20
1,200
20
1
20
16
320
20
1
20
120
2,400
20
1
20
20
400
3
1
3
4
12
1
1
1
2
2
10
10
100
5
500
........................
........................
........................
........................
5,223
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden per
recordkeeping
Total hours
516.141, requires the qualified expert panel leader to
maintain a copy of the written report and all notes
or minutes relating to panel deliberations that are
submitted to the requestor for 2 years after the report is submitted.
516.165, requires the holder of an indexed drug to
maintain records of all information pertinent to the
safety or effectiveness of the indexed drug, from
foreign and domestic sources.
30
2
60
0.5 ..........................
(30 minutes) ...........
30
10
2
20
1 .............................
20
Total ......................................................................
........................
........................
........................
................................
50
1
jbell on DSKJLSW7X2PROD with NOTICES
Number of
records per
recordkeeper
There are no capital costs or operating and maintenance costs associated with this collection of information.
We based our estimates in tables 1
and 2 on our experience with the
MUMS indexing program and the
requests for eligibility for indexing and
for addition to the index, as well as the
periodic drug experience reports
submitted during the past 3 years.
Our estimated burden for the
information collection reflects an
overall increase of 351 reporting hours
and a corresponding increase of 85
responses. We attribute this adjustment,
generally, to an increase in the number
of submissions we received over the last
few years. We also reduced our burden
hour estimate for drug experience
VerDate Sep<11>2014
18:56 Apr 29, 2020
Jkt 250001
reports and distributor statements under
§ 516.165 from 8 hours per submission
to 5 hours per submission based on our
experience with this type of reporting.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[Docket No. FDA–2020–N–0008]
[FR Doc. 2020–09170 Filed 4–29–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee:
Notice of Meeting; Postponement
AGENCY:
Food and Drug Administration,
HHS.
Notice of meeting;
postponement.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is postponing the
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]]>Agencies
[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23969-23970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Index of Legally
Marketed Unapproved New Animal Drugs for Minor Species
AGENCY: Food and Drug Administration, 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 June 1, 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 0910-0620. 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, 10A-12M, 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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species--21 CFR Part 516
OMB Control Number 0910-0620--Extension
The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS
Act) (Pub. L. 108-282) added section 572 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360ccc-1), which authorizes FDA to
establish new regulatory procedures intended to make more medications
legally available to veterinarians and animal owners for the treatment
of minor animal species (species other than cattle, horses, swine,
chickens, turkeys, dogs, and cats). In enacting the MUMS Act, Congress
sought to encourage the development of these new animal drugs. Congress
recognized that the markets for drugs intended to treat these species
are so small that there are often insufficient economic incentives to
motivate drug companies to develop data to support approvals. Further,
Congress recognized that some minor species populations are too small
or their management systems too diverse to make it practical to conduct
traditional studies to demonstrate safety and effectiveness of animal
drugs for such uses.
As a result of these limitations, drug companies have generally not
been willing or able to collect data to support legal marketing of
drugs for these species. Consequently, Congress enacted the MUMS Act to
provide incentives to develop new animal drugs for minor species, while
still ensuring appropriate safeguards for animal and human health.
Section 572 of the FD&C Act provides for a public index listing of
legally marketed unapproved new animal drugs for minor species. FDA
regulations in part 516 (21 CFR part 516) specify, among other things,
the criteria and procedures for requesting eligibility for indexing and
for requesting addition to the index, as well as the annual reporting
requirements for index holders. The administrative procedures and
criteria for indexing a new animal drug for use in a minor species are
set forth in Sec. Sec. 516.111 through 516.171 (21 CFR 516.111 through
516.171). Section 516.165 sets forth the annual reporting requirements
for index holders. FDA needs the information to determine: (1) The
eligibility of a new animal drug for indexing; (2) that a qualified
expert panel proposed to review certain information regarding the new
animal drug meets the selection criteria listed in the regulations; (3)
whether the Agency agrees with the recommendation of a qualified expert
panel that a drug be added to the index; and (4) whether there may be
grounds for removing a drug from the index.
In the Federal Register of January 7, 2020 (85 FR 714), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
[[Page 23970]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
516.119; requires a foreign drug 5 1 5 1 5
company to submit and update
the name and address of a
permanent U.S. resident agent..
516.121; written request for a 30 2 60 4 240
meeting with FDA to discuss the
requirements for indexing a new
animal drug....................
516.123; written request for an 3 1 3 8 24
informal conference and a
requestor's written response to
an FDA initial decision denying
a request......................
516.125; correspondence and 2 3 6 20 120
information associated with
investigational use of new
animal drugs intended for
indexing.......................
516.129; content and format of a 30 2 60 20 1,200
request for determination of
eligibility for indexing.......
516.141; information to be 20 1 20 16 320
submitted to FDA by a requestor
seeking to establish a
qualified expert panel.........
516.143; content and format of 20 1 20 120 2,400
the written report of the
qualified expert panel.........
516.145; content and format of a 20 1 20 20 400
request for addition to the
index..........................
516.161; content and format of a 3 1 3 4 12
request for modification of an
indexed drug...................
516.163; information to be 1 1 1 2 2
contained in a request to FDA
to transfer ownership of a
drug's index file to another
person.........................
516.165; requires drug 10 10 100 5 500
experience reports and
distributor statements to be
submitted to FDA...............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,223
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
516.141, requires the qualified expert panel 30 2 60 0.5...................................... 30
leader to maintain a copy of the written (30 minutes).............................
report and all notes or minutes relating to
panel deliberations that are submitted to
the requestor for 2 years after the report
is submitted.
516.165, requires the holder of an indexed 10 2 20 1........................................ 20
drug to maintain records of all information
pertinent to the safety or effectiveness of
the indexed drug, from foreign and domestic
sources.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We based our estimates in tables 1 and 2 on our experience with the
MUMS indexing program and the requests for eligibility for indexing and
for addition to the index, as well as the periodic drug experience
reports submitted during the past 3 years.
Our estimated burden for the information collection reflects an
overall increase of 351 reporting hours and a corresponding increase of
85 responses. We attribute this adjustment, generally, to an increase
in the number of submissions we received over the last few years. We
also reduced our burden hour estimate for drug experience reports and
distributor statements under Sec. 516.165 from 8 hours per submission
to 5 hours per submission based on our experience with this type of
reporting.
Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09170 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P
