82 FR 49836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 207 (October 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49836-49837 | |
| FR Document | 2017-23445 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49836-49837] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23445] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6145] Agency Information Collection Activities; Proposed Collection; 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 or Agency) 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 information collection provisions of the dispute resolution procedures for science-based decisions on products regulated by the Center for Veterinary Medicine (CVM). DATES: Submit either electronic or written comments on the collection of information by December 26, 2017. 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 December 26, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 26, 2017. 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''). 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-2017-N-6145 for ``Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine.'' 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.thefederalregister.org/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 [[Page 49837]] 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. Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM--21 CFR Section 10.75 OMB Control Number 0910-0566--Extension 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. FDA estimates the burden of this collection of information as follows: 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: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23445 Filed 10-26-17; 8:45 am] BILLING CODE 4164-01-P
![49836 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
Dated: October 24, 2017. Comments submitted electronically, its consideration of comments. The
Anna K. Abram, including attachments, to https:// second copy, which will have the
Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to claimed confidential information
Legislation, and Analysis. the docket unchanged. Because your redacted/blacked out, will be available
[FR Doc. 2017–23450 Filed 10–26–17; 8:45 am] comment will be made public, you are for public viewing and posted on
BILLING CODE 4164–01–P solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND third party may not wish to be posted, contact information to be made publicly
HUMAN SERVICES such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Food and Drug Administration confidential business information, such in the body of your comments and you
[Docket No. FDA–2017–N–6145] as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Agency Information Collection information, or other information that as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; identifies you in the body of your except in accordance with 21 CFR 10.20
Comment Request; Dispute Resolution comments, that information will be and other applicable disclosure law. For
Procedures for Science-Based posted on https://www.regulations.gov. more information about FDA’s posting
Decisions on Products Regulated by • If you want to submit a comment of comments to public dockets, see 80
the Center for Veterinary Medicine with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. written/paper submission and in the 23389.pdf.
ACTION: Notice. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
SUMMARY: The Food and Drug
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing an opportunity for public received, go to https://
Submit written/paper submissions as www.regulations.gov and insert the
comment on the proposed collection of follows: docket number, found in brackets in the
certain information by the Agency. • Mail/Hand delivery/Courier (for heading of this document, into the
Under the Paperwork Reduction Act of written/paper submissions): Dockets
1995 (PRA), Federal Agencies are ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
required to publish notice in the Drug Administration, 5630 Fishers
Federal Register concerning each Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
proposed collection of information, • For written/paper comments
including each proposed extension of an FOR FURTHER INFORMATION CONTACT: Ila
submitted to the Dockets Management
existing collection of information, and Staff, FDA will post your comment, as S. Mizrachi, Office of Operations, Food
to allow 60 days for public comment in well as any attachments, except for and Drug Administration, Three White
response to the notice. This notice information submitted, marked and Flint North, 10A–12M, 11601
solicits comments on the information identified, as confidential, if submitted Landsdown St., North Bethesda, MD
collection provisions of the dispute as detailed in ‘‘Instructions.’’ 20852, 301–796–7726, PRAStaff@
resolution procedures for science-based Instructions: All submissions received fda.hhs.gov.
decisions on products regulated by the must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
Center for Veterinary Medicine (CVM). 2017–N–6145 for ‘‘Dispute Resolution PRA (44 U.S.C. 3501–3520), Federal
DATES: Submit either electronic or Procedures for Science-Based Decisions Agencies must obtain approval from the
written comments on the collection of on Products Regulated by the Center for Office of Management and Budget
information by December 26, 2017. Veterinary Medicine.’’ Received (OMB) for each collection of
ADDRESSES: You may submit comments comments, those filed in a timely information they conduct or sponsor.
as follows. Please note that late, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
untimely filed comments will not be in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
considered. Electronic comments must submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
be submitted on or before December 26, Submissions,’’ publicly viewable at or requirements that members of the
2017. The https://www.regulations.gov https://www.regulations.gov or at the public submit reports, keep records, or
electronic filing system will accept Dockets Management Staff between 9 provide information to a third party.
comments until midnight Eastern Time a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44
at the end of December 26, 2017. Friday. U.S.C. 3506(c)(2)(A)) requires Federal
Comments received by mail/hand • Confidential Submissions—To Agencies to provide a 60-day notice in
delivery/courier (for written/paper submit a comment with confidential the Federal Register concerning each
submissions) will be considered timely information that you do not wish to be proposed collection of information,
if they are postmarked or the delivery made publicly available, submit your including each proposed extension of an
asabaliauskas on DSKBBXCHB2PROD with NOTICES
service acceptance receipt is on or comments only as a written/paper existing collection of information,
before that date. submission. You should submit two before submitting the collection to OMB
copies total. One copy will include the for approval. To comply with this
Electronic Submissions information you claim to be confidential requirement, FDA is publishing notice
Submit electronic comments in the with a heading or cover note that states of the proposed collection of
following way: ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The With respect to the following
https://www.regulations.gov. Follow the Agency will review this copy, including collection of information, FDA invites
instructions for submitting comments. the claimed confidential information, in comments on these topics: (1) Whether
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![Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49837
the proposed collection of information Science-Based Decisions on Products scientific disagreement with a written
is necessary for the proper performance Regulated by the Center for Veterinary decision by CVM, they may submit a
of FDA’s functions, including whether Medicine’’ (https://www.fda.gov/ request for a review of that decision by
the information will have practical downloads/AnimalVeterinary/ following the established procedures
utility; (2) the accuracy of FDA’s GuidanceComplianceEnforcement/ discussed in the guidance.
estimate of the burden of the proposed GuidanceforIndustry/UCM052393.pdf), CVM encourages applicants to begin
collection of information, including the describes the process by which CVM
validity of the methodology and the resolution of science-based disputes
formally resolves disputes relating to
assumptions used; (3) ways to enhance with discussions with the review team/
scientific controversies. A scientific
the quality, utility, and clarity of the group, including the Team Leader or
controversy involves issues concerning
information to be collected; and (4) Division Director. The Center prefers
a specific product regulated by CVM
ways to minimize the burden of the related to matters of technical expertise that differences of opinion regarding
collection of information on and requires specialized education, science or science-based policy be
respondents, including through the use training, or experience to be understood resolved between the review team/group
of automated collection techniques, and resolved. The guidance details and the applicant. If the matter is not
when appropriate, and other forms of information on how CVM intends to resolved by this preferred method then
information technology. apply provisions of existing regulations CVM recommends that the applicant
Dispute Resolution Procedures for regarding internal review of Agency follow the procedures in GFI #79.
Science-Based Decisions on Products decisions. In addition, the guidance FDA estimates the burden of this
Regulated by CVM—21 CFR Section outlines the established procedures for collection of information as follows:
10.75 persons who are sponsors, applicants, or
manufacturers of animal drugs or other
OMB Control Number 0910–0566— products regulated by CVM that wish to
Extension submit a request for review of a
CVM’s Guidance for Industry (GIF) scientific dispute. When a sponsor,
#79, ‘‘Dispute Resolution Procedures for applicant, or manufacturer has a
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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 DEPARTMENT OF HEALTH AND by December 26, 2017 to ensure that the
receiving one or fewer requests for HUMAN SERVICES Agency considers your comment on this
review of a scientific dispute per year, draft guidance before it begins work on
on average. We base our estimate on Food and Drug Administration the final version of the guidance.
CVM’s experience over the past 6 years [Docket No. FDA–2017–D–5912] ADDRESSES: You may submit comments
in handling formal appeals for scientific on any guidance at any time as follows:
disputes. The burden of this collection Pediatric Gastroesophageal Reflux
has changed. The number of Disease: Developing Drugs for Electronic Submissions
respondents decreased from two to one Treatment; Draft Guidance for
Submit electronic comments in the
annually, the number of responses per Industry; Availability
following way:
respondent remained at four annually, AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
the hours per response remained at 10 HHS. https://www.regulations.gov. Follow the
annually, and the total number of hours ACTION: Notice of availability. instructions for submitting comments.
decreased from 80 to 40. This decrease Comments submitted electronically,
in the total hours is the result of a SUMMARY: The Food and Drug including attachments, to https://www.
natural fluctuation in the number of Administration (FDA or Agency) is regulations.gov will be posted to the
respondents taking advantage of this announcing the availability of a draft docket unchanged. Because your
dispute resolution process. guidance for industry entitled ‘‘Pediatric comment will be made public, you are
Dated: October 24, 2017.
Gastroesophageal Reflux Disease: solely responsible for ensuring that your
Developing Drugs for Treatment.’’ The comment does not include any
Anna K. Abram, purpose of this draft guidance is to confidential information that you or a
Deputy Commissioner for Policy, Planning, assist sponsors in the clinical third party may not wish to be posted,
Legislation, and Analysis. development of drugs for the treatment
asabaliauskas on DSKBBXCHB2PROD with NOTICES
such as medical information, your or
[FR Doc. 2017–23445 Filed 10–26–17; 8:45 am] of gastroesophageal reflux disease anyone else’s Social Security number, or
BILLING CODE 4164–01–P (GERD) in the pediatric patient confidential business information, such
population, including guidance on as a manufacturing process. Please note
clinical presentation by age and disease, that if you include your name, contact
study populations, endpoints, and information, or other information that
pharmacometric issues affecting dosing. identifies you in the body of your
DATES: Submit either electronic or comments, that information will be
written comments on the draft guidance posted on https://www.regulations.gov.
VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/82_FR_50043/page/2.svg)
Document Created: 2017-10-27 02:06:38
Document Modified: 2017-10-27 02:06:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by December 26, 2017. | |
| 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] | |
| FR Citation | 82 FR 49836 |
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