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, 59787-59788 [2015-25121]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 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.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 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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Alice Tsai, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1149, Silver Spring, MD 20993–0002, 240–402–6069, Alice.Tsai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On July 9, 2012, the President signed into law FDASIA. This new law includes the reauthorization of PDUFA that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. Title I of FDASIA is the fifth authorization of PDUFA and includes by reference the performance goals and procedures for PDUFA V transmitted by the Secretary of Health and Human Services to Congress in a commitment letter. FDA developed recommendations for PDUFA V in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders from July 2010 through May 2011. These recommendations included an FDA commitment to contract with an independent accounting or consulting firm to review the adequacy of the PDUFA adjustment for changes in workload (hereafter referred to as the workload adjuster). The workload adjuster was introduced in PDUFA III to allow for FDA to augment the total user fee revenue amount each fiscal year (after adjusting for inflation) to account for changes in workload volume in the human drug application review process. Workload volume is measured by the changes in the number of new drug applications (NDAs) and biologics license applications (BLAs), active commercial investigational new drugs (INDs), efficacy supplements, and manufacturing supplements submitted to the human drug review program during the most recent 5-year period. VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 In PDUFA IV, the workload adjuster was expanded to account for the workload complexity (known as the adjustment for changes in review activities; hereafter referred to as the Complexity Factor) associated with the review of NDAs/BLAs and active commercial INDs. The NDA/BLA complexity is measured by changes in the number of labeling supplements, annual report reviews, and NDA/BLA meetings per NDA/BLA. IND complexity is measured by changes in the number of special protocol assessments and IND meetings per active commercial IND. As part of the PDUFA IV recommendations, FDA committed to an evaluation of the adjustment for changes in review activities by an independent consulting firm. The study, conducted by Deloitte & Touche, LLP, in fiscal year (FY) 2009, found that the adjustment methodology used by FDA reasonably captures changes in the workload complexity for reviewing human drug applications under PDUFA IV. Although the FY 2009 evaluation concluded that the adjustment methodology was reasonable at that time, the complexity of new drug applications and FDA’s regulatory responsibilities are constantly evolving. Moreover, the complexity component of the PDUFA IV workload adjuster was formulated before the enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Thus, the workload adjuster does not account for new and significant review activities required by FDAAA, such as risk evaluation and mitigation strategies, safety labeling changes, advisory committee meetings, and post-market safety requirements, among others. Given the dynamic nature of drug products and FDA’s regulatory responsibilities, FDA committed to periodic reassessments of the workload adjuster in PDUFA V to ensure that it is achieving its intended role of adjusting the user fee revenues to reflect actual changes in FDA s workload volume and complexity. The PDUFA V commitment letter instructs FDA to contract with an independent accounting or consulting firm to conduct two assessments of the workload adjuster. The first assessment (to examine the performance of the workload adjuster since FY 2009) conducted by IBM in FY 2013, found that the workload adjuster does reasonably represent changes in workload volume associated with the human drug review process. However, the report concluded that methodology was flawed with respect to measuring workload complexity, because it does PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 59787 not represent total amount of work per submission. The report recommended that FDA consider removing the Complexity Factor. In addition, the report found that the workload adjuster’s use of 5-year rolling averages to measure changes in workload against the base years was not as sensitive to recent trends as 3-year rolling averages would be. The report is available at https://www.fda.gov/downloads/ ForIndustry/UserFees/ PrescriptionDrugUserFee/UCM350567. After reviewing the report and public comments, FDA discontinued the use of the Complexity Factor in the adjustment methodology and adopted 3-year averages to measure changes in workload volume. The second assessment (to address the recommendations from the first evaluation and assess the continued performance of the workload adjuster) was just completed. The independent consulting firm is required to submit a report based on its assessment. The report will evaluate whether the workload adjuster reasonably represents actual changes in workload volume and will present options to discontinue, retain, or modify any elements of the adjustment. After review of the report and receipt of public comment, FDA, if warranted, may adopt appropriate changes to the methodology. FDA is seeking public comment now on the second assessment of the PDUFA Workload Adjuster, available at https:// www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/ UCM464878.pdf. Dated: September 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25117 Filed 10–1–15; 8:45 am] BILLING CODE 4164–01–P 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. Request for comments; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the SUMMARY: E:\FR\FM\02OCN1.SGM 02OCN1 59788 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 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. Submit either electronic or written comments by November 2, 2015. ADDRESSES: You may submit comments as follows: DATES: 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’’). mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 Vivo Bioequivalence of Product Performance and Quality of NonSystemically 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 https://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 https:// 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: https://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 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 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 selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information SUMMARY: E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59787-59788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25121]


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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: 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): 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 https://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 https://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: https://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 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 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
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