80 FR 59787 - Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 191 (October 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 191 (October 2, 2015)
| Page Range | 59787-59788 | |
| FR Document | 2015-25121 |
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)] [Notices] [Pages 59787-59788] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25121] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0684] Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening the [[Page 59788]] comment period related to the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of nonsystemically absorbed drug products intended for use in veterinary species, published in the Federal Register of March 18, 2015 (80 FR 14146). FDA is reopening the comment period to receive new information. DATES: Submit either electronic or written comments by November 2, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-N-0684 for Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: John Harshman, CVM, Food and Drug Administration, HFV-170, MPN2, 7500 Standish Place, Rockville, MD 20855, 240-402-0845. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 18, 2015 (80 FR 14146), FDA announced a public meeting to discuss the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence of nonsystemically absorbed drug products intended for use in veterinary species. In the same notice, FDA said that it is seeking additional public comment to the docket. Interested persons were originally given until May 18, 2015, to comment on this issue. Following publication of that notice, FDA received a request to allow interested persons additional time to comment. In response to that request, FDA published a Federal Register notice on June 10, 2015, reopening the comment period for 60 days, until August 10, 2015. II. Request for Comments Following publication of the June 10, 2015, notice reopening the comment period for 60 days, FDA received a request to allow interested persons an additional 30 days to comment. FDA has considered the request and is reopening the comment period for 30 days, until November 2, 2015. Dated: September 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25121 Filed 10-1-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59787
applicable disclosure law. For more In PDUFA IV, the workload adjuster not represent total amount of work per
information about FDA’s posting of was expanded to account for the submission. The report recommended
comments to public dockets, see 80 FR workload complexity (known as the that FDA consider removing the
56469, September 18, 2015, or access adjustment for changes in review Complexity Factor. In addition, the
the information at: http://www.fda.gov/ activities; hereafter referred to as the report found that the workload
regulatoryinformation/dockets/ Complexity Factor) associated with the adjuster’s use of 5-year rolling averages
default.htm. review of NDAs/BLAs and active to measure changes in workload against
Docket: For access to the docket to commercial INDs. The NDA/BLA the base years was not as sensitive to
read background documents or the complexity is measured by changes in recent trends as 3-year rolling averages
electronic and written/paper comments the number of labeling supplements, would be. The report is available at
received, go to http:// annual report reviews, and NDA/BLA http://www.fda.gov/downloads/
www.regulations.gov and insert the meetings per NDA/BLA. IND ForIndustry/UserFees/
docket number, found in brackets in the complexity is measured by changes in PrescriptionDrugUserFee/UCM350567.
heading of this document, into the the number of special protocol After reviewing the report and public
‘‘Search’’ box and follow the prompts assessments and IND meetings per comments, FDA discontinued the use of
and/or go to the Division of Dockets active commercial IND. the Complexity Factor in the adjustment
Management, 5630 Fishers Lane, rm. As part of the PDUFA IV methodology and adopted 3-year
1061, Rockville, MD 20852. recommendations, FDA committed to an averages to measure changes in
FOR FURTHER INFORMATION CONTACT:
evaluation of the adjustment for changes workload volume.
Alice Tsai, Center for Drug Evaluation in review activities by an independent The second assessment (to address the
and Research, Food and Drug consulting firm. The study, conducted recommendations from the first
Administration, 10903 New Hampshire by Deloitte & Touche, LLP, in fiscal year evaluation and assess the continued
Ave., Bldg. 51, Rm. 1149, Silver Spring, (FY) 2009, found that the adjustment performance of the workload adjuster)
MD 20993–0002, 240–402–6069, methodology used by FDA reasonably was just completed. The independent
Alice.Tsai@fda.hhs.gov. captures changes in the workload consulting firm is required to submit a
complexity for reviewing human drug report based on its assessment. The
SUPPLEMENTARY INFORMATION: On July 9,
applications under PDUFA IV. Although report will evaluate whether the
2012, the President signed into law the FY 2009 evaluation concluded that workload adjuster reasonably represents
FDASIA. This new law includes the the adjustment methodology was actual changes in workload volume and
reauthorization of PDUFA that provides reasonable at that time, the complexity will present options to discontinue,
FDA with the necessary resources to of new drug applications and FDA’s retain, or modify any elements of the
maintain a predictable and efficient regulatory responsibilities are adjustment. After review of the report
review process for human drug and constantly evolving. Moreover, the and receipt of public comment, FDA, if
biologic products. complexity component of the PDUFA IV warranted, may adopt appropriate
Title I of FDASIA is the fifth workload adjuster was formulated changes to the methodology.
authorization of PDUFA and includes before the enactment of the Food and FDA is seeking public comment now
by reference the performance goals and Drug Administration Amendments Act on the second assessment of the PDUFA
procedures for PDUFA V transmitted by of 2007 (FDAAA). Thus, the workload Workload Adjuster, available at http://
the Secretary of Health and Human adjuster does not account for new and www.fda.gov/downloads/ForIndustry/
Services to Congress in a commitment significant review activities required by UserFees/PrescriptionDrugUserFee/
letter. FDA developed recommendations FDAAA, such as risk evaluation and UCM464878.pdf.
for PDUFA V in consultation with drug mitigation strategies, safety labeling Dated: September 29, 2015.
industry representatives, patient and changes, advisory committee meetings,
consumer advocates, health care Leslie Kux,
and post-market safety requirements, Associate Commissioner for Policy.
professionals, and other public among others.
stakeholders from July 2010 through [FR Doc. 2015–25117 Filed 10–1–15; 8:45 am]
Given the dynamic nature of drug
May 2011. These recommendations products and FDA’s regulatory BILLING CODE 4164–01–P
included an FDA commitment to responsibilities, FDA committed to
contract with an independent periodic reassessments of the workload
accounting or consulting firm to review adjuster in PDUFA V to ensure that it is DEPARTMENT OF HEALTH AND
the adequacy of the PDUFA adjustment achieving its intended role of adjusting HUMAN SERVICES
for changes in workload (hereafter the user fee revenues to reflect actual Food and Drug Administration
referred to as the workload adjuster). changes in FDA s workload volume and
The workload adjuster was complexity. [Docket No. FDA–2015–N–0684]
introduced in PDUFA III to allow for The PDUFA V commitment letter
FDA to augment the total user fee instructs FDA to contract with an Identification of Alternative In Vitro
revenue amount each fiscal year (after independent accounting or consulting Bioequivalence Pathways Which Can
adjusting for inflation) to account for firm to conduct two assessments of the Reliably Ensure In Vivo Bioequivalence
changes in workload volume in the workload adjuster. The first assessment of Product Performance and Quality of
human drug application review process. (to examine the performance of the Non-Systemically Absorbed Drug
Workload volume is measured by the workload adjuster since FY 2009) Products for Animals; Reopening of
the Comment Period
mstockstill on DSK4VPTVN1PROD with NOTICES
changes in the number of new drug conducted by IBM in FY 2013, found
applications (NDAs) and biologics that the workload adjuster does AGENCY: Food and Drug Administration,
license applications (BLAs), active reasonably represent changes in HHS.
commercial investigational new drugs workload volume associated with the ACTION:Request for comments;
(INDs), efficacy supplements, and human drug review process. However, reopening of the comment period.
manufacturing supplements submitted the report concluded that methodology
to the human drug review program was flawed with respect to measuring SUMMARY: The Food and Drug
during the most recent 5-year period. workload complexity, because it does Administration (FDA) is reopening the
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![59788 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
comment period related to the use of in Vivo Bioequivalence of Product for electronic access to the guidance
vitro methods as a mechanism for Performance and Quality of Non- document.
assessing the in vivo product Systemically Absorbed Drug Products FOR FURTHER INFORMATION CONTACT: John
bioequivalence (BE) of nonsystemically for Animals; Reopening of the Comment Harshman, CVM, Food and Drug
absorbed drug products intended for use Period. Received comments will be Administration, HFV–170, MPN2, 7500
in veterinary species, published in the placed in the docket and, except for Standish Place, Rockville, MD 20855,
Federal Register of March 18, 2015 (80 those submitted as ‘‘Confidential 240–402–0845.
FR 14146). FDA is reopening the Submissions,’’ publicly viewable at
SUPPLEMENTARY INFORMATION:
comment period to receive new http://www.regulations.gov or at the
information. Division of Dockets Management I. Background
between 9 a.m. and 4 p.m., Monday In the Federal Register of March 18,
DATES: Submit either electronic or
through Friday. 2015 (80 FR 14146), FDA announced a
written comments by November 2, 2015. • Confidential Submissions—To
ADDRESSES: You may submit comments public meeting to discuss the use of in
submit a comment with confidential vitro methods as a mechanism for
as follows: information that you do not wish to be assessing the in vivo product
Electronic Submissions made publicly available submit your bioequivalence of nonsystemically
comments only as a written/paper absorbed drug products intended for use
Submit electronic comments in the submission. You should submit two
following way: in veterinary species. In the same
copies total. One copy will include the notice, FDA said that it is seeking
• Federal eRulemaking Portal: http:// information you claim to be confidential
www.regulations.gov. Follow the additional public comment to the
with a heading or cover note that states docket. Interested persons were
instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Comments submitted electronically, originally given until May 18, 2015, to
CONFIDENTIAL INFORMATION’’. The comment on this issue. Following
including attachments, to http:// Agency will review this copy, including
www.regulations.gov will be posted to publication of that notice, FDA received
the claimed confidential information, in
the docket unchanged. Because your a request to allow interested persons
its consideration of comments. The
comment will be made public, you are additional time to comment. In response
second copy, which will have the
solely responsible for ensuring that your to that request, FDA published a
claimed confidential information
comment does not include any Federal Register notice on June 10,
redacted/blacked out, will be available
confidential information that you or a 2015, reopening the comment period for
for public viewing and posted on http://
third party may not wish to be posted, 60 days, until August 10, 2015.
www.regulations.gov. Submit both
such as medical information, your or copies to the Division of Dockets II. Request for Comments
anyone else’s Social Security number, or Management. If you do not wish your Following publication of the June 10,
confidential business information, such name and contact information to be 2015, notice reopening the comment
as a manufacturing process. Please note made publicly available, you can period for 60 days, FDA received a
that if you include your name, contact provide this information on the cover request to allow interested persons an
information, or other information that sheet and not in the body of your additional 30 days to comment. FDA
identifies you in the body of your comments and you must identify this has considered the request and is
comments, that information will be information as ‘‘confidential.’’ Any reopening the comment period for 30
posted on http://www.regulations.gov. information marked as ‘‘confidential’’
• If you want to submit a comment days, until November 2, 2015.
will not be disclosed except in
with confidential information that you accordance with 21 CFR 10.20 and other Dated: September 28, 2015.
do not wish to be made available to the applicable disclosure law. For more Leslie Kux,
public submit the comment as a written/ information about FDA’s posting of Associate Commissioner for Policy.
paper submission and in the manner comments to public dockets, see 80 FR [FR Doc. 2015–25121 Filed 10–1–15; 8:45 am]
detailed (see ‘‘Written/Paper 56469, September 18, 2015, or access BILLING CODE 4164–01–P
Submissions’’ and ‘‘Instructions’’). the information at: http://www.fda.gov/
Written/Paper Submissions regulatoryinformation/dockets/
default.htm. DEPARTMENT OF HEALTH AND
Submit written/paper submissions as Docket: For access to the docket to HUMAN SERVICES
follows: read background documents or the
• Mail/Hand delivery/Courier (for electronic and written/paper comments Health Resources and Services
written/paper submissions): Division of received, go to http:// Administration
Dockets Management (HFA–305), Food www.regulations.gov and insert the
and Drug Administration, 5630 Fishers docket number, found in brackets in the Agency Information Collection
Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the Activities: Proposed Collection: Public
• For written/paper comments ‘‘Search’’ box and follow the prompts Comment Request
submitted to the Division of Dockets and/or go to the Division of Dockets AGENCY: Health Resources and Services
Management, FDA will post your Management, 5630 Fishers Lane, Rm. Administration, HHS.
comment, as well as any attachments, 1061, Rockville, MD 20852. ACTION: Notice.
except for information submitted, Submit written requests for single
mstockstill on DSK4VPTVN1PROD with NOTICES
marked and identified, as confidential, copies of the guidance to the Policy and SUMMARY: In compliance with the
if submitted as detailed in Regulations Staff (HFV–6), Center for requirement for opportunity for public
‘‘Instructions.’’ Veterinary Medicine, Food and Drug comment on proposed data collection
Instructions: All submissions received Administration, 7519 Standish Pl., projects (section 3506(c)(2)(A) of the
must include the Docket No. FDA– Rockville, MD 20855. Send one self- Paperwork Reduction Act of 1995), the
2015–N–0684 for Identification of addressed adhesive label to assist that Health Resources and Services
Alternative In Vitro Bioequivalence office in processing your requests. See Administration (HRSA) announces
Pathways Which Can Reliably Ensure In the SUPPLEMENTARY INFORMATION section plans to submit an Information
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Document Created: 2015-12-15 08:45:18
Document Modified: 2015-12-15 08:45:18
| 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 | Request for comments; reopening of the comment period. | |
| Dates | Submit either electronic or written comments by November 2, 2015. | |
| Contact | John Harshman, CVM, Food and Drug Administration, HFV-170, MPN2, 7500 Standish Place, Rockville, MD 20855, 240-402-0845. | |
| FR Citation | 80 FR 59787 |
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