Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine, 5783-5784 [2018-02593]
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Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
2006, which was 30 days after FDA
receipt of an earlier 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: December 17,
2014. FDA has verified the applicant’s
claim that the new drug application
(NDA) for ENTRESTO (NDA 207620)
was initially submitted on December 17,
2014.
3. The date the application was
approved: July 7, 2015. FDA has verified
the applicant’s claim that NDA 207620
was approved on July 7, 2015.
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 1,296 days, 732
days, 519 days, 270 days or 225 days of
patent term extension.
III. Petitions
sradovich on DSK3GMQ082PROD with NOTICES
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.
VerDate Sep<11>2014
16:57 Feb 08, 2018
Jkt 244001
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02592 Filed 2–8–18; 8:45 am]
5783
Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine—21 CFR 10.75
BILLING CODE 4164–01–P
OMB Control Number 0910–0566—
Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Center for Veterinary Medicine’s
(CVM’s) Guidance for Industry (GIF)
#79, ‘‘Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine’’ (https://www.fda.gov/
downloads/AnimalVeterinary/Guidance
ComplianceEnforcement/Guidancefor
Industry/UCM052393.pdf), describes the
process by which CVM formally
resolves disputes relating to scientific
controversies. A scientific controversy
involves issues concerning a specific
product regulated by CVM related to
matters of technical expertise and
requires specialized education, training,
or experience to be understood and
resolved. The guidance details
information on how CVM intends to
apply provisions of existing regulations
regarding internal review of Agency
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants, or
manufacturers of animal drugs or other
products regulated by CVM that wish to
submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established procedures
discussed in the guidance.
CVM encourages applicants to begin
the resolution of science-based disputes
with discussions with the review team/
group, including the Team Leader or
Division Director. The Center prefers
that differences of opinion regarding
science or science-based policy be
resolved between the review team/group
and the applicant. If the matter is not
resolved by this preferred method then
CVM recommends that the applicant
follow the procedures in GFI #79.
In the Federal Register of October 27,
2017 (82 FR 49836), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received no comments.
FDA estimates the burden of this
collection of information as follows:
Food and Drug Administration
[Docket No. FDA–2017–N–6145]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Dispute Resolution
Procedures for Science-Based
Decisions on Products Regulated by
the Center for Veterinary Medicine
AGENCY:
Food and Drug Administration,
HHS.
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.
DATES: Fax written comments on the
collection of information by March 12,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0566. 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.
SUMMARY:
PO 00000
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09FEN1
5784
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
10.75, Request for review of a scientific dispute ................
1
4
4
10
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the next 3 years, CVM anticipates
receiving one or fewer requests for
review of a scientific dispute per year,
on average. We base our estimate on
CVM’s experience over the past 6 years
in handling formal appeals for scientific
disputes. The burden of this collection
has changed. The number of
respondents decreased from two to one
annually, the number of responses per
respondent remained at four annually,
the hours per response remained at 10
annually, and the total number of hours
decreased from 80 to 40. This decrease
in the total hours is the result of a
natural fluctuation in the number of
respondents taking advantage of this
dispute resolution process.
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02593 Filed 2–8–18; 8:45 am]
BILLING CODE 4164–01–P
Fax written comments on the
collection of information by March 12,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0770. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0334]
Postmarketing Safety Reports for
Human Drug and Biological Products:
Waivers From Electronic Submission
Requirements
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Safety Reports for Human Drug and
Biological Products: Electronic
Submission Requirements
OMB Control Number 0910–0770—
Extension
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.
This information collection supports
information collection found in FDA
regulations. In the Federal Register of
June 10, 2014 (79 FR 33072), FDA
published a final rule entitled
‘‘Postmarketing Safety Reports for
Human Drug and Biological Products:
Electronic Submission Requirements.’’
The final rule amended FDA’s
postmarketing safety reporting
regulations for human drug and
biological products under 21 CFR parts
310, 314, and 600 and added part 329
1 FDA currently has OMB approval for
submission of postmarketing safety reports under
parts 310, 314, and 600. The information collection
for parts 310 and 314 is approved under OMB
Control Numbers 0910–0291 and 0910–0230. The
information collection for part 600 is approved
under OMB Control Numbers 0910–0291 and 0910–
0308. Submissions required by section 760 of the
AGENCY:
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
Notice.
VerDate Sep<11>2014
16:57 Feb 08, 2018
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to require that persons subject to
mandatory reporting requirements
submit safety reports in an electronic
format that FDA can process, review,
and archive. Specifically, this includes:
• Manufacturers; packers;
distributors; applicants with approved
new drug applications, abbreviated new
drug applications, and biologics
licensing applications (BLAs); and those
that market prescription drugs for
human use without an approved
application must submit postmarketing
safety reports to the Agency (§§ 310.305,
314.80, 314.98, and 600.80);
• manufacturers, packers, or
distributors whose name appears on the
label of nonprescription human drug
products marketed without an approved
application must report serious adverse
events associated with their products
(section 760 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
379aa)); and
• applicants with approved BLAs
must submit biological lot distribution
reports to the Agency (§ 600.81).
Under §§ 310.305(e)(2), 314.80(g)(2),
329.100(c)(2), 600.80(h)(2), and
600.81(b)(2), of the regulations, those
who are subject to these postmarketing
safety reporting requirements may
request a waiver from the electronic
format requirement. While FDA
currently has OMB approval for the
collection of postmarketing safety
reports,1 this information collection
supports respondents seeking waivers
from submitting those reports in
electronic format as required by the
regulations.
In the Federal Register of October 30,
2017 (82 FR 50141), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received in response to the notice.
We therefore estimate the burden of
this collection of information as follows:
FD&C Act have been approved under OMB Control
Number 0910–0636.
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5783-5784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6145]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Dispute Resolution
Procedures for Science-Based Decisions on Products Regulated by the
Center for Veterinary Medicine
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: Fax written comments on the collection of information by March
12, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0566.
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.
Dispute Resolution Procedures for Science-Based Decisions on Products
Regulated by the Center for Veterinary Medicine--21 CFR 10.75
OMB Control Number 0910-0566--Extension
The Center for Veterinary Medicine's (CVM's) Guidance for Industry
(GIF) #79, ``Dispute Resolution Procedures for Science-Based Decisions
on Products Regulated by the Center for Veterinary Medicine'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052393.pdf), describes the process by which CVM
formally resolves disputes relating to scientific controversies. A
scientific controversy involves issues concerning a specific product
regulated by CVM related to matters of technical expertise and requires
specialized education, training, or experience to be understood and
resolved. The guidance details information on how CVM intends to apply
provisions of existing regulations regarding internal review of Agency
decisions. In addition, the guidance outlines the established
procedures for persons who are sponsors, applicants, or manufacturers
of animal drugs or other products regulated by CVM that wish to submit
a request for review of a scientific dispute. When a sponsor,
applicant, or manufacturer has a scientific disagreement with a written
decision by CVM, they may submit a request for a review of that
decision by following the established procedures discussed in the
guidance.
CVM encourages applicants to begin the resolution of science-based
disputes with discussions with the review team/group, including the
Team Leader or Division Director. The Center prefers that differences
of opinion regarding science or science-based policy be resolved
between the review team/group and the applicant. If the matter is not
resolved by this preferred method then CVM recommends that the
applicant follow the procedures in GFI #79.
In the Federal Register of October 27, 2017 (82 FR 49836), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received no comments.
FDA estimates the burden of this collection of information as
follows:
[[Page 5784]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75, Request for review of a scientific dispute.................. 1 4 4 10 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In the next 3 years, CVM anticipates receiving one or fewer
requests for review of a scientific dispute per year, on average. We
base our estimate on CVM's experience over the past 6 years in handling
formal appeals for scientific disputes. The burden of this collection
has changed. The number of respondents decreased from two to one
annually, the number of responses per respondent remained at four
annually, the hours per response remained at 10 annually, and the total
number of hours decreased from 80 to 40. This decrease in the total
hours is the result of a natural fluctuation in the number of
respondents taking advantage of this dispute resolution process.
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02593 Filed 2-8-18; 8:45 am]
BILLING CODE 4164-01-P
