Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use, 7735-7738 [2018-03609]
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
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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 LYMPHOSEEK
(technetium (Tc 99m) tilmanocept).
LYMPHOSEEK is indicated for
lymphatic mapping with a hand-held
gamma counter to assist in the
localization of lymph nodes draining a
primary tumor site in patients with
breast cancer or melanoma. Subsequent
to this approval, the USPTO received a
patent term restoration application for
LYMPHOSEEK (U.S. Patent No.
6,409,990) from Navidea
Biopharmaceuticals, Inc., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
November 4, 2015, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
LYMPHOSEEK 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
LYMPHOSEEK is 4,398 days. Of this
time, 3,816 days occurred during the
testing phase of the regulatory review
period, while 582 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 (the FD&C Act) (21
U.S.C. 355(i)) became effective:
February 28, 2001. FDA has verified the
applicant’s claim that the date the
investigational new drug application
became effective was on February 28,
2001.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: August 10,
2011. FDA has verified the applicant’s
claim that the new drug application
(NDA) for LYMPHOSEEK (NDA 202207)
was initially submitted on August 10,
2011.
3. The date the application was
approved: March 13, 2013. FDA has
verified the applicant’s claim that NDA
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202207 was approved on March 13,
2013.
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 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
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03610 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0341]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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7735
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the reporting and
recordkeeping requirements of our
regulations concerning new animal
drugs for investigational use.
Submit either electronic or
written comments on the collection of
information by April 23, 2018.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–0341 for ‘‘New Animal Drugs
for Investigational Use.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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: 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.
‘‘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 (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
New Animal Drugs for Investigational
Use—21 CFR Part 511
OMB Control Number 0910–0117—
Extension
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to approve new animal
drugs. A new animal drug application
(NADA) cannot be approved until,
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among other things, the new animal
drug has been demonstrated to be safe
and effective for its intended use(s). In
order to properly test a new animal drug
for an intended use, appropriate
scientific investigations must be
conducted. Under specific
circumstances, section 512(j) of the
FD&C Act (21 U.S.C. 360b(j)) permits
the use of an investigational new animal
drug to generate data to support an
NADA approval. Section 512(j) of the
FD&C Act authorizes us to issue
regulations relating to the
investigational use of new animal drugs.
Our regulations in part 511 (21 CFR
part 511) set forth the conditions for
investigational use of new animal drugs
and require reporting and
recordkeeping. The information
collected is necessary to protect the
public health. We use the information to
determine that investigational animal
drugs are distributed only to qualified
investigators, adequate drug
accountability records are maintained,
and edible food products from treated
food-producing animals are safe for
human consumption. We also use the
information collected to monitor the
validity of the studies submitted to us
to support new animal drug approval.
Reporting: Our regulations require
that certain information be submitted to
us in a ‘‘Notice of Claimed
Investigational Exemption for a New
Animal Drug’’ (NCIE) to qualify for the
exemption and to control shipment of
the new animal drug and prevent
potential abuse. The NCIE must contain,
among other things, the following
specific information: (1) Identity of the
new animal drug, (2) labeling, (3)
statement of compliance of any nonclinical laboratory studies with good
laboratory practices, (4) name and
address of each clinical investigator, (5)
the approximate number of animals to
be treated or amount of new animal
drug(s) to be shipped, and (6)
information regarding the use of edible
tissues from investigational animals
(§ 511.1(b)(4) (21 CFR 511.1(b)(4)). If the
new animal drug is to be used in foodproducing animals, e.g., cattle, swine,
chickens, fish, etc., certain data must be
submitted to us to obtain authorization
for the use of edible food products from
treated food-producing animals
(§ 511.1(b)(5)). We require sponsors
upon request to submit information
with respect to the investigation to
determine whether there are grounds for
terminating the exemption
(§ 511.1(b)(6)). We require sponsors to
report findings that may suggest
significant hazards pertinent to the
safety of the new animal drug
(§ 511.1(b)(8)(ii)). We also require
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reporting by importers of investigational
new animal drugs for clinical
investigational use in animals
(§ 511.1(b)(9)). The information
provided by the sponsor in the NCIE is
needed to ensure that the proposed
investigational use of the new animal
drug is safe and that any edible food
will not be distributed without proper
authorization from FDA. Information
contained in an NCIE submission is
monitored under our Bio-Research
Monitoring Program. This program
permits us to monitor the validity of the
studies and to ensure the proper use of
the drugs is maintained by the
investigators.
Recordkeeping: If the new animal
drug is only for tests in vitro or in
laboratory research animals, the person
distributing the new animal drug must
maintain records showing the name and
post office address of the expert or
expert organization to whom it is
shipped and the date, quantity, and
batch or code mark of each shipment
and delivery for a period of 2 years after
such shipment or delivery (§ 511.1(a)(3)
and (b)(3)). We require complete records
of the investigation, including records of
the receipt and disposition of each
shipment or delivery of the
investigational new animal drug
(§ 511.1(b)(7)). We also require records
of all reports received by a sponsor from
investigators to be retained for 2 years
after the termination of an
investigational exemption or approval of
a new animal drug application
(§ 511.1(b)(8)(i)).
Description of Respondents:
Respondents to this collection of
information are persons who use new
animal drugs for investigational
purposes. Investigational new animal
drugs are used primarily by drug
industry firms, academic institutions,
and the government. Investigators may
include individuals from these entities,
as well as research firms and members
of the medical professions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/activity
511.1(b)(4); submission of NCIE .........................................
511.1(b)(5); submission of data to obtain authorization for
the use of edible food products .......................................
511.1(b)(6); submission of any additional information upon
request of FDA .................................................................
511.1(b)(8)(ii); reporting of findings that may suggest significant hazards pertinent to the safety of the new animal drug ...........................................................................
511.1(b)(9); reporting by importers of investigational new
animal drugs for clinical investigational use in animals ...
Total ..............................................................................
1 There
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
104
15.38
1,600
1
1,600
104
0.30
31
8
248
104
0.02
2
1
2
104
0.14
15
2
30
104
0.14
15
8
120
........................
........................
1,663
........................
2,000
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/activity
511.1(a)(3); maintain records showing the name and post
office address of the expert or expert organization to
whom the new animal drug is shipped and the date,
quantity, and batch or code mark of each shipment and
delivery for a period of 2 years after such shipment or
delivery .............................................................................
511.1(b)(3); maintain records showing the name and post
office address of the expert or expert organization to
whom the new animal drug or feed containing same is
shipped and the date, quantity, and batch or code mark
of each shipment and delivery for a period of 2 years
after such shipment or delivery ........................................
511.1(b)(7); maintain records of the investigation, including
records of the receipt and disposition of each shipment
or delivery of the investigational new animal drug ..........
511.1(b)(8)(i); maintain records of all reports received by a
sponsor from investigators ...............................................
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Total ..............................................................................
1 There
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
104
2.5
260
1
260
104
15.38
1,600
1
1,600
104
15.38
1,600
3.5
5,600
104
15.38
1,600
3.5
5,600
........................
........................
5,060
........................
13,060
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
reporting requirements, record
preparation, and maintenance for this
collection of information is based on our
informal communication with industry.
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Based on the number of sponsors
subject to animal drug user fees, we
estimate that there are 104 respondents.
We use this estimate consistently
throughout the table and calculate the
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‘‘number of responses per respondent’’
by dividing the total annual responses
by number of respondents. Additional
information needed to make a final
calculation of the total burden hours
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
(i.e., the number of respondents, the
number of recordkeepers, the number of
NCIEs received, etc.) is derived from our
records. The burden for this information
collection has changed since the last
OMB approval. We estimate an overall
increase in burden that we attribute to
an increase in the number of annual
responses and records.
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03609 Filed 2–21–18; 8:45 am]
Approval is withdrawn as of
March 26, 2018.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DATES:
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2018–N–0508]
Parke-Davis, Subsidiary of Pfizer, Inc.
et al.; Withdraw of Approval of 38 New
Drug Applications and 43 Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 38 new drug
applications (NDAs) and 43 abbreviated
new drug applications (ANDAs) from
multiple applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
BILLING CODE 4164–01–P
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
TABLE 1
Application No.
Drug
Applicant
NDA 010151 ......
Dilantin (phenytoin sodium) Injection USP, 50 milligrams
(mg)/milliliter (mL).
Zolyse (chymotrypsin) for Ophthalmic Solution, 750 units/vial
Parke-Davis, Subsidiary of Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017.
Alcon Laboratories, Inc., 6201 S. Freeway, TC–45, Fort
Worth, TX 76134–2099.
Hospira Inc., 8401 W. 102nd St., Pleasant Prairie, WI 53158.
NDA 011903 ......
NDA 012125 ......
NDA 012516 ......
NDA 016774 ......
NDA 016775 ......
NDA 016793 ......
NDA 016997 ......
NDA 017364 ......
NDA 017575 ......
NDA 017717 ......
NDA
NDA
NDA
NDA
017869
017993
018052
018128
......
......
......
......
Carbocaine (mepivacaine hydrochloride (HCl)) Injection USP,
3%.
Carbocaine
with
Neo-Cobefrin
(mepivacaine
HCl;
levonordefrin) Injection USP, 2%; 0.05 mg/mL.
Sansert (methysergide maleate) Tablets, 2 mg ......................
Serentil (mesoridazine besylate) Tablets, Equivalent to (EQ)
10 mg base, 25 mg base, 50 mg base, and 100 mg base.
Serentil (mesoridazine besylate) Injection, EQ 25 mg base/
mL.
Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500
mg/vial, 1 gram (g)/vial, and 2 g/vial.
Serentil (mesoridazine besylate) Oral Concentrate, EQ 25
mg base/mL.
Aquatensen (methyclothiazide) Tablets USP, 5 mg ................
DTIC-Dome (dacarbazine) for Injection, 100 mg/vial and 200
mg/vial.
Gyne-Lotrimin (clotrimazole) Vaginal Tablets, 100 mg ...........
NDA 018418 ......
NDA 018439 ......
Funduscein-25 (fluorescein sodium) Injection, 25% ................
Hydergine (ergoloid mesylates) Tablets, 0.5 mg and 1 mg ....
Gyne-Lotrimin (clotrimazole) Vaginal Cream, 1% ...................
Ovcon-50 (norethindrone and ethinyl estradiol) Tablets USP
(21-Day Regimen), 1 mg and 0.05 mg.
Chlor-Trimeton
(chlorpheniramine
maleate
and
pseudoephedrine sulfate) Extended-Release Tablets, 8 mg
and 120 mg.
Hydergine (ergoloid mesylates) Oral Solution, 1 mg/mL .........
Multi-Vitamins Concentrate for Infusion, Injection ...................
NDA 018471 ......
NDA 018517 ......
Ocuclear (oxymetazoline HCl) Ophthalmic Solution, 0.025%
Metronidazole Tablets USP, 250 mg and 500 mg ..................
NDA 018969 ......
NDA 020045 ......
Liposyn III 10% (soybean oil) Injection, 10% ..........................
Shade UVAGuard (avobenzone, octinoxate, oxybenzone) Lotion, 3%/7.5%/3%.
Gyne-Lotrimin Combination Pack (clotrimazole) Vaginal
Cream and Vaginal Tablets, 1% and 100 mg.
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NDA 018397 ......
NDA 020289 ......
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Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936–1080.
Do.
Do.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham,
PA 19044.
Novartis Pharmaceuticals Corp.
Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 400,
Somerset, NJ 08873.
Bayer Healthcare Pharmaceuticals, Inc., 100 Bayer Blvd.,
Whippany, NJ 07981.
Bayer HealthCare, LLC, 100 Bayer Blvd., P.O. Box 915,
Whippany, NJ 07981–0915.
Novartis Pharmaceuticals Corp.
Do.
Bayer HealthCare, LLC.
Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC,
100 Enterprise Dr., Rockaway, NJ 07866.
Bayer HealthCare, LLC.
Novartis Pharmaceuticals Corp.
Watson Laboratories, Inc., Subsidiary of Teva
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
Bayer HealthCare, LLC.
IVAX Pharmaceuticals, Inc., Subsidiary of Teva
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
Hospira, Inc.
Bayer HealthCare, LLC.
Do.
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Pharma19044.
]]>Agencies
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7735-7738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0341]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drugs for Investigational Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting and
recordkeeping requirements of our regulations concerning new animal
drugs for investigational use.
DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
[[Page 7736]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-0341 for ``New Animal Drugs for Investigational Use.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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: 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.
``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 (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
New Animal Drugs for Investigational Use--21 CFR Part 511
OMB Control Number 0910-0117--Extension
FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to approve new animal drugs. A new animal drug
application (NADA) cannot be approved until, among other things, the
new animal drug has been demonstrated to be safe and effective for its
intended use(s). In order to properly test a new animal drug for an
intended use, appropriate scientific investigations must be conducted.
Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C.
360b(j)) permits the use of an investigational new animal drug to
generate data to support an NADA approval. Section 512(j) of the FD&C
Act authorizes us to issue regulations relating to the investigational
use of new animal drugs.
Our regulations in part 511 (21 CFR part 511) set forth the
conditions for investigational use of new animal drugs and require
reporting and recordkeeping. The information collected is necessary to
protect the public health. We use the information to determine that
investigational animal drugs are distributed only to qualified
investigators, adequate drug accountability records are maintained, and
edible food products from treated food-producing animals are safe for
human consumption. We also use the information collected to monitor the
validity of the studies submitted to us to support new animal drug
approval.
Reporting: Our regulations require that certain information be
submitted to us in a ``Notice of Claimed Investigational Exemption for
a New Animal Drug'' (NCIE) to qualify for the exemption and to control
shipment of the new animal drug and prevent potential abuse. The NCIE
must contain, among other things, the following specific information:
(1) Identity of the new animal drug, (2) labeling, (3) statement of
compliance of any non-clinical laboratory studies with good laboratory
practices, (4) name and address of each clinical investigator, (5) the
approximate number of animals to be treated or amount of new animal
drug(s) to be shipped, and (6) information regarding the use of edible
tissues from investigational animals (Sec. 511.1(b)(4) (21 CFR
511.1(b)(4)). If the new animal drug is to be used in food-producing
animals, e.g., cattle, swine, chickens, fish, etc., certain data must
be submitted to us to obtain authorization for the use of edible food
products from treated food-producing animals (Sec. 511.1(b)(5)). We
require sponsors upon request to submit information with respect to the
investigation to determine whether there are grounds for terminating
the exemption (Sec. 511.1(b)(6)). We require sponsors to report
findings that may suggest significant hazards pertinent to the safety
of the new animal drug (Sec. 511.1(b)(8)(ii)). We also require
[[Page 7737]]
reporting by importers of investigational new animal drugs for clinical
investigational use in animals (Sec. 511.1(b)(9)). The information
provided by the sponsor in the NCIE is needed to ensure that the
proposed investigational use of the new animal drug is safe and that
any edible food will not be distributed without proper authorization
from FDA. Information contained in an NCIE submission is monitored
under our Bio-Research Monitoring Program. This program permits us to
monitor the validity of the studies and to ensure the proper use of the
drugs is maintained by the investigators.
Recordkeeping: If the new animal drug is only for tests in vitro or
in laboratory research animals, the person distributing the new animal
drug must maintain records showing the name and post office address of
the expert or expert organization to whom it is shipped and the date,
quantity, and batch or code mark of each shipment and delivery for a
period of 2 years after such shipment or delivery (Sec. 511.1(a)(3)
and (b)(3)). We require complete records of the investigation,
including records of the receipt and disposition of each shipment or
delivery of the investigational new animal drug (Sec. 511.1(b)(7)). We
also require records of all reports received by a sponsor from
investigators to be retained for 2 years after the termination of an
investigational exemption or approval of a new animal drug application
(Sec. 511.1(b)(8)(i)).
Description of Respondents: Respondents to this collection of
information are persons who use new animal drugs for investigational
purposes. Investigational new animal drugs are used primarily by drug
industry firms, academic institutions, and the government.
Investigators may include individuals from these entities, as well as
research firms and members of the medical professions.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4); submission of NCIE. 104 15.38 1,600 1 1,600
511.1(b)(5); submission of data 104 0.30 31 8 248
to obtain authorization for the
use of edible food products....
511.1(b)(6); submission of any 104 0.02 2 1 2
additional information upon
request of FDA.................
511.1(b)(8)(ii); reporting of 104 0.14 15 2 30
findings that may suggest
significant hazards pertinent
to the safety of the new animal
drug...........................
511.1(b)(9); reporting by 104 0.14 15 8 120
importers of investigational
new animal drugs for clinical
investigational use in animals.
-------------------------------------------------------------------------------
Total....................... .............. .............. 1,663 .............. 2,000
----------------------------------------------------------------------------------------------------------------
\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 Average burden
21 CFR Section/activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
511.1(a)(3); maintain records 104 2.5 260 1 260
showing the name and post
office address of the expert or
expert organization to whom the
new animal drug is shipped and
the date, quantity, and batch
or code mark of each shipment
and delivery for a period of 2
years after such shipment or
delivery.......................
511.1(b)(3); maintain records 104 15.38 1,600 1 1,600
showing the name and post
office address of the expert or
expert organization to whom the
new animal drug or feed
containing same is shipped and
the date, quantity, and batch
or code mark of each shipment
and delivery for a period of 2
years after such shipment or
delivery.......................
511.1(b)(7); maintain records of 104 15.38 1,600 3.5 5,600
the investigation, including
records of the receipt and
disposition of each shipment or
delivery of the investigational
new animal drug................
511.1(b)(8)(i); maintain records 104 15.38 1,600 3.5 5,600
of all reports received by a
sponsor from investigators.....
-------------------------------------------------------------------------------
Total....................... .............. .............. 5,060 .............. 13,060
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the time required for reporting requirements,
record preparation, and maintenance for this collection of information
is based on our informal communication with industry. Based on the
number of sponsors subject to animal drug user fees, we estimate that
there are 104 respondents. We use this estimate consistently throughout
the table and calculate the ``number of responses per respondent'' by
dividing the total annual responses by number of respondents.
Additional information needed to make a final calculation of the total
burden hours
[[Page 7738]]
(i.e., the number of respondents, the number of recordkeepers, the
number of NCIEs received, etc.) is derived from our records. The burden
for this information collection has changed since the last OMB
approval. We estimate an overall increase in burden that we attribute
to an increase in the number of annual responses and records.
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03609 Filed 2-21-18; 8:45 am]
BILLING CODE 4164-01-P
