Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff; Availability, 66013-66014 [2015-27418]

Download as PDF Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices (44 U.S.C. 3501–3520). The collection of information in 21 CFR part 312 (investigational new drug applications) has been approved under OMB control number 0910–0014. The collection of information in 21 CFR part 314 (new drug applications) has been approved under OMB control number 0910–0001. The collection of information resulting from special protocol assessments has been approved under OMB control number 0910–0470. The collection of information resulting from formal meetings between applicants and FDA has been approved under OMB control number 0910–0429. The collection of information resulting from good laboratory practices has been approved under OMB control number 0910–0119. The collection of information resulting from current good manufacturing practices has been approved under OMB control number 0910–0139. III. Electronic Access Persons with access to the Internet may obtain the document athttps://www. fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/RegulatoryInformation/Guidances/ default.htm, or https:// www.regulations.gov. Dated: October 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27361 Filed 10–27–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0142] Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ‘‘Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.’’ The guidance provides recommendations concerning the evaluation of the nonclinical safety mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 of reformulated drug products or products being used by an alternate route. It is intended for use by interested individuals in industry and reviewers within the Center for Drug Evaluation and Research (CDER). The goals of this guidance are to foster and expedite the development of reformulated drug products or the use of previously approved drugs by alternate routes, communicate to industry current CDER thoughts pertaining to safety data needed to support these drug products, and increase uniformity within CDER on expectations for the nonclinical development of reformulated drug products or products being used by an alternate route. This guidance finalizes the draft guidance of the same name published on March 7, 2008. DATES: Submit either electronic or written comments on Agency guidances at any time. 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 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 66013 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– 2008–D–0142 for ‘‘Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff.’’ 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. E:\FR\FM\28OCN1.SGM 28OCN1 66014 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. 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: Paul C. Brown, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 22, Rm. 6472, Silver Spring, MD 20993–0002, 301–796–0856. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance for industry and review staff entitled ‘‘Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.’’ This guidance provides recommendations regarding the nonclinical evaluation of a new formulation containing a previously approved drug substance and of a product proposed for use by an alternate route of administration for which the product was not previously approved. Generally, nonclinical data support use of a drug product by a particular route and also reflect the planned duration of use. Much of the available nonclinical information used to support approval of the initial formulation can be used to support the safety of additional formulations assuming all legal rights to the information are met. Information used to support an initial formulation, however, may not always be sufficient to support such additional approvals because changes in the formulation could produce a new toxicity. This is particularly true if the drug product’s route of administration is different or the duration of use changes markedly. Therefore, additional nonclinical studies might be recommended to ensure that the toxicity of a new formulation is fully characterized. This guidance provides general nonclinical considerations for all reformulations or new routes of use and several route-specific considerations. The considerations in this guidance can also be applied to routes not specifically mentioned in the guidance. This guidance finalizes the draft guidance of the same name published on March 7, 2008. Changes to the guidance include the addition of a recommendation that toxicology studies VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 be conducted under good laboratory practices, clarification that histopathology can be limited in some cases to locally exposed tissues, the addition of a reference to the International Conference on Harmonisation guidance for industry entitled ‘‘S10 Photosafety Evaluation of Pharmaceuticals,’’ and other clarifications to the studies recommended for specific routes such as dermal, ocular, and intranasal. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: October 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27418 Filed 10–27–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Diseases Agents, Drug Resistance and Drug Discovery. Date: November 16–17, 2015. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301–435– 2306, boundst@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Skeletal Muscle. Date: November 17, 2015. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Daniel F McDonald, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4110, MSC 7814, Bethesda, MD 20892, (301) 435– 1215, mcdonald@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Pathophysiological Correlates of Visual System Disorders and Mechanisms of Intervention. Date: November 19, 2015. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Alessandra C Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205 MSC7846, Bethesda, MD 20892, (301) 435– 1021, rovescaa@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 23, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–27427 Filed 10–27–15; 8:45 am] BILLING CODE 4140–01–P Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Biology of Infectious PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66013-66014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0142]


Nonclinical Safety Evaluation of Reformulated Drug Products and 
Products Intended for Administration by an Alternate Route; Guidance 
for Industry and Review Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry and review staff entitled 
``Nonclinical Safety Evaluation of Reformulated Drug Products and 
Products Intended for Administration by an Alternate Route.'' The 
guidance provides recommendations concerning the evaluation of the 
nonclinical safety of reformulated drug products or products being used 
by an alternate route. It is intended for use by interested individuals 
in industry and reviewers within the Center for Drug Evaluation and 
Research (CDER). The goals of this guidance are to foster and expedite 
the development of reformulated drug products or the use of previously 
approved drugs by alternate routes, communicate to industry current 
CDER thoughts pertaining to safety data needed to support these drug 
products, and increase uniformity within CDER on expectations for the 
nonclinical development of reformulated drug products or products being 
used by an alternate route. This guidance finalizes the draft guidance 
of the same name published on March 7, 2008.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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-2008-D-0142 for ``Nonclinical Safety Evaluation of Reformulated 
Drug Products and Products Intended for Administration by an Alternate 
Route; Guidance for Industry and Review Staff.'' 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.

[[Page 66014]]

    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Paul C. Brown, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg., 22, Rm. 6472, Silver Spring, MD 20993-0002, 301-
796-0856.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
review staff entitled ``Nonclinical Safety Evaluation of Reformulated 
Drug Products and Products Intended for Administration by an Alternate 
Route.'' This guidance provides recommendations regarding the 
nonclinical evaluation of a new formulation containing a previously 
approved drug substance and of a product proposed for use by an 
alternate route of administration for which the product was not 
previously approved.
    Generally, nonclinical data support use of a drug product by a 
particular route and also reflect the planned duration of use. Much of 
the available nonclinical information used to support approval of the 
initial formulation can be used to support the safety of additional 
formulations assuming all legal rights to the information are met. 
Information used to support an initial formulation, however, may not 
always be sufficient to support such additional approvals because 
changes in the formulation could produce a new toxicity. This is 
particularly true if the drug product's route of administration is 
different or the duration of use changes markedly. Therefore, 
additional nonclinical studies might be recommended to ensure that the 
toxicity of a new formulation is fully characterized.
    This guidance provides general nonclinical considerations for all 
reformulations or new routes of use and several route-specific 
considerations. The considerations in this guidance can also be applied 
to routes not specifically mentioned in the guidance.
    This guidance finalizes the draft guidance of the same name 
published on March 7, 2008. Changes to the guidance include the 
addition of a recommendation that toxicology studies be conducted under 
good laboratory practices, clarification that histopathology can be 
limited in some cases to locally exposed tissues, the addition of a 
reference to the International Conference on Harmonisation guidance for 
industry entitled ``S10 Photosafety Evaluation of Pharmaceuticals,'' 
and other clarifications to the studies recommended for specific routes 
such as dermal, ocular, and intranasal.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on nonclinical safety evaluation of 
reformulated drug products and products intended for administration by 
an alternate route. It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27418 Filed 10-27-15; 8:45 am]
 BILLING CODE 4164-01-P
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