80 FR 66013 - Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 208 (October 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 208 (October 28, 2015)
| Page Range | 66013-66014 | |
| FR Document | 2015-27418 |
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)] [Notices] [Pages 66013-66014] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27418] ----------------------------------------------------------------------- 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 This guidance finalizes the draft guidance of the same name published on March 7, 2008.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: 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-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 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. [[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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices 66013
(44 U.S.C. 3501–3520). The collection of of reformulated drug products or Management, FDA will post your
information in 21 CFR part 312 products being used by an alternate comment, as well as any attachments,
(investigational new drug applications) route. It is intended for use by interested except for information submitted,
has been approved under OMB control individuals in industry and reviewers marked and identified, as confidential,
number 0910–0014. The collection of within the Center for Drug Evaluation if submitted as detailed in
information in 21 CFR part 314 (new and Research (CDER). The goals of this ‘‘Instructions’’.
drug applications) has been approved guidance are to foster and expedite the Instructions: All submissions received
under OMB control number 0910–0001. development of reformulated drug must include the Docket No. FDA–
The collection of information resulting products or the use of previously 2008–D–0142 for ‘‘Nonclinical Safety
from special protocol assessments has approved drugs by alternate routes, Evaluation of Reformulated Drug
been approved under OMB control communicate to industry current CDER Products and Products Intended for
number 0910–0470. The collection of thoughts pertaining to safety data Administration by an Alternate Route;
information resulting from formal needed to support these drug products, Guidance for Industry and Review
meetings between applicants and FDA and increase uniformity within CDER Staff.’’ Received comments will be
has been approved under OMB control on expectations for the nonclinical placed in the docket and, except for
number 0910–0429. The collection of development of reformulated drug those submitted as ‘‘Confidential
information resulting from good products or products being used by an Submissions,’’ publicly viewable at
laboratory practices has been approved alternate route. This guidance finalizes http://www.regulations.gov or at the
under OMB control number 0910–0119. the draft guidance of the same name Division of Dockets Management
The collection of information resulting published on March 7, 2008. between 9 a.m. and 4 p.m., Monday
from current good manufacturing through Friday.
DATES: Submit either electronic or
practices has been approved under OMB • Confidential Submissions—To
written comments on Agency guidances submit a comment with confidential
control number 0910–0139. at any time. information that you do not wish to be
III. Electronic Access ADDRESSES: You may submit comments made publicly available, submit your
Persons with access to the Internet as follows: comments only as a written/paper
may obtain the document athttp://www. Electronic Submissions submission. You should submit two
fda.gov/Drugs/GuidanceCompliance copies total. One copy will include the
RegulatoryInformation/Guidances/ Submit electronic comments in the information you claim to be confidential
default.htm, http://www.fda.gov/ following way: with a heading or cover note that states
BiologicsBloodVaccines/Guidance • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
ComplianceRegulatoryInformation/ www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
Guidances/default.htm, http://www.fda. instructions for submitting comments. Agency will review this copy, including
gov/RegulatoryInformation/Guidances/ Comments submitted electronically, the claimed confidential information, in
default.htm, or http:// including attachments, to http:// its consideration of comments. The
www.regulations.gov. www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Dated: October 22, 2015.
comment will be made public, you are redacted/blacked out, will be available
Leslie Kux,
solely responsible for ensuring that your for public viewing and posted on http://
Associate Commissioner for Policy. comment does not include any www.regulations.gov. Submit both
[FR Doc. 2015–27361 Filed 10–27–15; 8:45 am] confidential information that you or a copies to the Division of Dockets
BILLING CODE 4164–01–P third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
anyone else’s Social Security number, or made publicly available, you can
DEPARTMENT OF HEALTH AND confidential business information, such provide this information on the cover
HUMAN SERVICES as a manufacturing process. Please note sheet and not in the body of your
Food and Drug Administration that if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential’’. Any
[Docket No. FDA–2008–D–0142] identifies you in the body of your information marked as ‘‘confidential’’
comments, that information will be will not be disclosed except in
Nonclinical Safety Evaluation of posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Reformulated Drug Products and • If you want to submit a comment applicable disclosure law. For more
Products Intended for Administration with confidential information that you information about FDA’s posting of
by an Alternate Route; Guidance for do not wish to be made available to the comments to public dockets, see 80 FR
Industry and Review Staff; Availability public, submit the comment as a 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, written/paper submission and in the the information at: http://www.fda.gov/
HHS. manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). default.htm.
Docket: For access to the docket to
SUMMARY: The Food and Drug Written/Paper Submissions read background documents or the
Administration (FDA or Agency) is Submit written/paper submissions as electronic and written/paper comments
mstockstill on DSK4VPTVN1PROD with NOTICES
announcing the availability of a follows: received, go to http://
guidance for industry and review staff • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
entitled ‘‘Nonclinical Safety Evaluation written/paper submissions): Division of docket number, found in brackets in the
of Reformulated Drug Products and Dockets Management (HFA–305), Food heading of this document, into the
Products Intended for Administration and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
by an Alternate Route.’’ The guidance Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
provides recommendations concerning • For written/paper comments Management, 5630 Fishers Lane, Rm.
the evaluation of the nonclinical safety submitted to the Division of Dockets 1061, Rockville, MD 20852.
VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\28OCN1.SGM 28OCN1](https://thefederalregister.org/doc/80_FR_66221/page/1.svg)
![66014 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices
Submit written requests for single be conducted under good laboratory Diseases Agents, Drug Resistance and Drug
copies of this guidance to the Division practices, clarification that Discovery.
of Drug Information, Center for Drug histopathology can be limited in some Date: November 16–17, 2015.
Evaluation and Research, Food and cases to locally exposed tissues, the Time: 9:00 a.m. to 6:00 p.m.
Drug Administration, 10001 New addition of a reference to the Agenda: To review and evaluate grant
Hampshire Ave., Hillandale Building, International Conference on applications.
4th Floor, Silver Spring, MD 20993– Harmonisation guidance for industry Place: National Institutes of Health, 6701
0002. Send one self-addressed adhesive entitled ‘‘S10 Photosafety Evaluation of Rockledge Drive, Bethesda, MD 20892
label to assist that office in processing Pharmaceuticals,’’ and other (Virtual Meeting).
your requests. See the SUPPLEMENTARY clarifications to the studies Contact Person: Tera Bounds, DVM, Ph.D.,
INFORMATION section for electronic recommended for specific routes such Scientific Review Officer, Center for
access to the guidance document. as dermal, ocular, and intranasal. Scientific Review, National Institutes of
This guidance is being issued Health, 6701 Rockledge Drive, Room 3214,
FOR FURTHER INFORMATION CONTACT: Paul
consistent with FDA’s good guidance MSC 7808, Bethesda, MD 20892, 301–435–
C. Brown, Center for Drug Evaluation 2306, boundst@csr.nih.gov.
and Research, Food and Drug practices regulation (21 CFR 10.115).
Administration, 10903 New Hampshire The guidance represents the current Name of Committee: Center for Scientific
thinking of FDA on nonclinical safety Review Special Emphasis Panel; Small
Ave., Bldg., 22, Rm. 6472, Silver Spring,
evaluation of reformulated drug Business: Skeletal Muscle.
MD 20993–0002, 301–796–0856.
products and products intended for Date: November 17, 2015.
SUPPLEMENTARY INFORMATION: Time: 4:00 p.m. to 5:00 p.m.
administration by an alternate route. It
I. Background does not establish any rights for any Agenda: To review and evaluate grant
person and is not binding on FDA or the applications.
FDA is announcing the availability of Place: National Institutes of Health, 6701
a guidance for industry and review staff public. You can use an alternative
approach if it satisfies the requirements Rockledge Drive, Bethesda, MD 20892,
entitled ‘‘Nonclinical Safety Evaluation (Telephone Conference Call).
of Reformulated Drug Products and of the applicable statutes and
regulations. Contact Person: Daniel F McDonald, Ph.D.,
Products Intended for Administration Scientific Review Officer, Center for
by an Alternate Route.’’ This guidance II. Electronic Access Scientific Review, National Institutes of
provides recommendations regarding Health, 6701 Rockledge Drive, Room 4110,
Persons with access to the Internet
the nonclinical evaluation of a new MSC 7814, Bethesda, MD 20892, (301) 435–
may obtain the document at either
formulation containing a previously 1215, mcdonald@csr.nih.gov.
http://www.fda.gov/Drugs/Guidance
approved drug substance and of a
ComplianceRegulatoryInformation/ Name of Committee: Center for Scientific
product proposed for use by an alternate
Guidances/default.htm or http:// Review Special Emphasis Panel;
route of administration for which the
www.regulations.gov. Pathophysiological Correlates of Visual
product was not previously approved. System Disorders and Mechanisms of
Generally, nonclinical data support Dated: October 21, 2015.
Intervention.
use of a drug product by a particular Leslie Kux,
Date: November 19, 2015.
route and also reflect the planned Associate Commissioner for Policy. Time: 9:00 a.m. to 6:00 p.m.
duration of use. Much of the available [FR Doc. 2015–27418 Filed 10–27–15; 8:45 am] Agenda: To review and evaluate grant
nonclinical information used to support BILLING CODE 4164–01–P applications.
approval of the initial formulation can Place: National Institutes of Health, 6701
be used to support the safety of Rockledge Drive, Bethesda, MD 20892.
additional formulations assuming all DEPARTMENT OF HEALTH AND Contact Person: Alessandra C Rovescalli,
legal rights to the information are met. HUMAN SERVICES Ph.D., Scientific Review Officer, National
Information used to support an initial Institutes of Health, Center for Scientific
formulation, however, may not always National Institutes of Health
Review, 6701 Rockledge Drive, Rm 5205
be sufficient to support such additional MSC7846, Bethesda, MD 20892, (301) 435–
Center for Scientific Review; Notice of
approvals because changes in the 1021, rovescaa@mail.nih.gov.
Closed Meetings
formulation could produce a new (Catalogue of Federal Domestic Assistance
toxicity. This is particularly true if the Pursuant to section 10(d) of the Program Nos. 93.306, Comparative Medicine;
drug product’s route of administration is Federal Advisory Committee Act, as 93.333, Clinical Research, 93.306, 93.333,
different or the duration of use changes amended (5 U.S.C. App.), notice is 93.337, 93.393–93.396, 93.837–93.844,
markedly. Therefore, additional hereby given of the following meetings. 93.846–93.878, 93.892, 93.893, National
nonclinical studies might be The meetings will be closed to the Institutes of Health, HHS)
recommended to ensure that the toxicity public in accordance with the
of a new formulation is fully provisions set forth in sections Dated: October 23, 2015.
characterized. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Carolyn Baum,
This guidance provides general as amended. The grant applications and Program Analyst, Office of Federal Advisory
nonclinical considerations for all the discussions could disclose Committee Policy.
reformulations or new routes of use and confidential trade secrets or commercial [FR Doc. 2015–27427 Filed 10–27–15; 8:45 am]
several route-specific considerations. property such as patentable material, BILLING CODE 4140–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
The considerations in this guidance can and personal information concerning
also be applied to routes not specifically individuals associated with the grant
mentioned in the guidance. applications, the disclosure of which
This guidance finalizes the draft would constitute a clearly unwarranted
guidance of the same name published invasion of personal privacy.
on March 7, 2008. Changes to the Name of Committee: Center for Scientific
guidance include the addition of a Review Special Emphasis Panel; Member
recommendation that toxicology studies Conflict: Topics in Biology of Infectious
VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 E:\FR\FM\28OCN1.SGM 28OCN1](https://thefederalregister.org/doc/80_FR_66221/page/2.svg)
Document Created: 2018-02-27 08:57:46
Document Modified: 2018-02-27 08:57:46
| 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 of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 66013 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR