80 FR 26062 - Administrative Applications and the Phased Review Process; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 87 (May 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 87 (May 6, 2015)
| Page Range | 26062-26063 | |
| FR Document | 2015-10480 |
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)] [Notices] [Pages 26062-26063] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10480] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0147 (formerly Docket No. 2002D-0449)] Administrative Applications and the Phased Review Process; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #132 entitled ``Administrative Applications and the Phased Review Process.'' This guidance defines the ``phased review process'' for reviewing application-level information during the investigational period of new animal drug development, and an ``administrative'' new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: 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 request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Katherine Weld, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0846, Katherine.Weld@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 6, 2002 (67 FR 67631), FDA published the notice of availability for a draft guidance entitled ``The Administrative New Animal Drug Application Process'' giving interested persons until January 21, 2003, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance was updated to clarify current processes and include information about generic new animal drugs. The guidance announced in this notice finalizes the draft guidance dated November 6, 2002. To be legally marketed, a new animal drug must be the subject of either an approved application under section 512(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b), a conditional approval under section 571 of the FD&C Act (21 U.S.C. 360ccc), or an index listing under section 572 of the FD&C Act (21 U.S.C. 360ccc-1). Sections 512(b)(1) and 512(n)(1) of the FD&C Act describes the information that must be submitted to FDA, specifically the Center for [[Page 26063]] Veterinary Medicine (CVM), as part of an NADA or ANADA, respectively. CVM encourages sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, we have found that the submission of data supporting discrete technical sections during the investigational phase of the new animal drug is the most appropriate and productive. This ``phased review'' of data submissions has created efficiencies for CVM and the animal pharmaceutical industry. These increased efficiencies have facilitated the approval of both pioneer and generic new animal drugs. This guidance defines what an administrative (A)NADA is, defines and describes the phased review process, and briefly discusses how sponsors should submit an administrative (A)NADA and the time frame for review. II. Significance of Guidance This level 1 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 Administrative Applications and the Phased Review Process. It does 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. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032. The collections of information in section 512(n)(1) of the FD&C Act have been approved under OMB control number 0910-0669. IV. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-10480 Filed 5-5-15; 8:45 am] BILLING CODE 4164-01-P
![26062 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices
populations to support indications in number 0910–0231 (subparts A through drug development, and an
the pediatric population. If E, premarket approval). ‘‘administrative’’ new animal drug
extrapolation is found to be appropriate, application (NADA) or abbreviated new
V. Reference
FDA believes that statistical modeling animal drug application (ANADA), the
and methods can be used to increase the The following reference have been content, the procedures a sponsor
precision of pediatric inferences. placed on display in the Division of should follow to submit such an
This guidance should be used in Dockets Management (see ADDRESSES), application, and the intended time
conjunction with other device-specific and may be seen by interested persons frame for its review.
guidances to help ensure that medical between 9 a.m. and 4 p.m., Monday
DATES: Submit either electronic or
devices intended for use in pediatric through Friday, and are available
written comments on Agency guidances
population provide reasonable electronically at http://
at any time.
assurance of safety and effectiveness. www.regulations.gov. (FDA has verified
the Web site address, but we are not ADDRESSES: Submit written requests for
II. Significance of Guidance single copies of the guidance to the
responsible for any subsequent changes
This draft guidance is being issued to the Web sites after this document Policy and Regulations Staff (HFV–6),
consistent with FDA’s good guidance publishes in the Federal Register.) Center for Veterinary Medicine, Food
practices regulation (21 CFR 10.115). 1. FDA guidance entitled ‘‘Premarket and Drug Administration, 7519 Standish
The draft guidance, when finalized, will Assessment of Pediatric Medical Pl., Rockville, MD 20855. Send one self-
represent the Agency’s current thinking Devices,’’ March 24, 2014, available at addressed adhesive label to assist that
on extrapolation of data for pediatric http://www.fda.gov/MedicalDevices/ office in processing your request. See
uses. It does not create or confer any DeviceRegulationandGuidance/ the SUPPLEMENTARY INFORMATION section
rights for or on any person and does not GuidanceDocuments/ucm089740.htm. for electronic access to the guidance
operate to bind FDA or the public. An document.
alternative approach may be used if VI. Comments Submit electronic comments on the
such approach satisfies the Interested persons may submit either guidance to http://www.regulations.gov.
requirements of the applicable statute electronic comments regarding this Submit written comments to the
and regulations. document to http://www.regulations.gov Division of Dockets Management (HFA–
or written comments to the Division of 305), Food and Drug Administration,
III. Electronic Access
Dockets Management (see ADDRESSES). It 5630 Fishers Lane, Rm. 1061, Rockville,
Persons interested in obtaining a copy is only necessary to send one set of MD 20852.
of the draft guidance may do so by comments. Identify comments with the FOR FURTHER INFORMATION CONTACT:
downloading an electronic copy from docket number found in brackets in the Katherine Weld, Center for Veterinary
the Internet. A search capability for all heading of this document. Received Medicine (HFV–108), Food and Drug
Center for Devices and Radiological comments may be seen in the Division Administration, 7500 Standish Pl.,
Health guidance documents is available of Dockets Management between 9 a.m. Rockville, MD 20855, 240–402–0846,
at http://www.fda.gov/MedicalDevices/ and 4 p.m., Monday through Friday, and Katherine.Weld@fda.hhs.gov.
DeviceRegulationandGuidance/ will be posted to the docket at http://
GuidanceDocuments/default.htm. www.regulations.gov. SUPPLEMENTARY INFORMATION:
Guidance documents are also available Dated: April 30, 2015. I. Background
at http://www.regulations.gov. Persons
Leslie Kux, In the Federal Register of November
unable to download an electronic copy
of ‘‘Leveraging Existing Clinical Data for Associate Commissioner for Policy. 6, 2002 (67 FR 67631), FDA published
Extrapolation to Pediatric Uses of [FR Doc. 2015–10482 Filed 5–5–15; 8:45 am] the notice of availability for a draft
Medical Devices’’ may send an email BILLING CODE 4164–01–P guidance entitled ‘‘The Administrative
request to CDRH-Guidance@fda.hhs.gov New Animal Drug Application Process’’
to receive an electronic copy of the giving interested persons until January
document. Please use the document DEPARTMENT OF HEALTH AND 21, 2003, to comment on the draft
number 1827 to identify the guidance HUMAN SERVICES guidance. FDA received several
you are requesting. comments on the draft guidance and
Food and Drug Administration those comments were considered as the
IV. Paperwork Reduction Act of 1995 [Docket No. FDA–2002–D–0147 (formerly guidance was finalized. The guidance
This draft guidance refers to Docket No. 2002D–0449)] was updated to clarify current processes
previously approved collections of and include information about generic
information found in FDA regulations. Administrative Applications and the new animal drugs. The guidance
These collections of information are Phased Review Process; Guidance for announced in this notice finalizes the
subject to review by the Office of Industry; Availability draft guidance dated November 6, 2002.
Management and Budget (OMB) under AGENCY: Food and Drug Administration, To be legally marketed, a new animal
the Paperwork Reduction Act of 1995 HHS. drug must be the subject of either an
(44 U.S.C. 3501–3520). The collections ACTION: Notice. approved application under section
of information in 21 CFR parts 801 and 512(b) of the Federal Food, Drug, and
809 have been approved under OMB SUMMARY: The Food and Drug Cosmetic Act (the FD&C Act) (21 U.S.C.
control number 0910–0485 (medical Administration (FDA) is announcing the 360b), a conditional approval under
tkelley on DSK3SPTVN1PROD with NOTICES
device labeling); the collections of availability of a guidance for industry section 571 of the FD&C Act (21 U.S.C.
information in 21 CFR part 812 have (GFI) #132 entitled ‘‘Administrative 360ccc), or an index listing under
been approved under OMB control Applications and the Phased Review section 572 of the FD&C Act (21 U.S.C.
number 0910–0078 (investigational Process.’’ This guidance defines the 360ccc–1). Sections 512(b)(1) and
device exemptions); the collections of ‘‘phased review process’’ for reviewing 512(n)(1) of the FD&C Act describes the
information in 21 CFR part 814 have application-level information during the information that must be submitted to
been approved under OMB control investigational period of new animal FDA, specifically the Center for
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![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices 26063
Veterinary Medicine (CVM), as part of will be posted to the docket at http:// Administration, 5630 Fishers Lane, Rm.
an NADA or ANADA, respectively. www.regulations.gov. 1061, Rockville, MD 20852.
CVM encourages sponsors to submit
data for review at the most appropriate V. Electronic Access FOR FURTHER INFORMATION CONTACT:
and productive times in the drug Persons with access to the Internet Xiaoqiu Tang, Center for Drug
development process. Rather than may obtain the guidance at either Evaluation and Research, Food and
submitting all data for review as part of http://www.fda.gov/AnimalVeterinary/ Drug Administration, 10903 New
a complete application, we have found GuidanceComplianceEnforcement/ Hampshire Ave., Bldg. 75, Rm. 4730,
that the submission of data supporting GuidanceforIndustry/default.htm or Silver Spring, MD 20993–0002, 301–
discrete technical sections during the http://www.regulations.gov. 796–5850.
investigational phase of the new animal Dated: April 30, 2015. SUPPLEMENTARY INFORMATION:
drug is the most appropriate and Leslie Kux,
productive. This ‘‘phased review’’ of I. Background
Associate Commissioner for Policy.
data submissions has created
[FR Doc. 2015–10480 Filed 5–5–15; 8:45 am] In the Federal Register of June 11,
efficiencies for CVM and the animal
BILLING CODE 4164–01–P 2010 (75 FR 33311), FDA announced the
pharmaceutical industry. These
increased efficiencies have facilitated availability of a guidance for industry,
the approval of both pioneer and generic ‘‘Bioequivalence Recommendations for
DEPARTMENT OF HEALTH AND Specific Products,’’ which explained the
new animal drugs.
This guidance defines what an HUMAN SERVICES process that would be used to make
administrative (A)NADA is, defines and product-specific BE recommendations
Food and Drug Administration available to the public on FDA’s Web
describes the phased review process,
and briefly discusses how sponsors [Docket No. FDA–2015–D–1378] site at http://www.fda.gov/Drugs/
should submit an administrative GuidanceComplianceRegulatory
(A)NADA and the time frame for review. Bioequivalence Recommendations for Information/Guidances/default.htm. As
Clozapine Orally Disintegrating described in that guidance, FDA
II. Significance of Guidance Tablets/Oral; Draft Guidance for adopted this process as a means to
This level 1 guidance is being issued Industry; Availability develop and disseminate product-
consistent with FDA’s good guidance specific BE recommendations and
AGENCY: Food and Drug Administration,
practices regulation (21 CFR 10.115). provide a meaningful opportunity for
HHS.
The guidance represents the current the public to consider and comment on
thinking of FDA on Administrative ACTION: Notice. those recommendations. This notice
Applications and the Phased Review SUMMARY: The Food and Drug announces the availability of one draft
Process. It does establish any rights for Administration (FDA) is announcing the BE recommendation for clozapine
any person and is not binding on FDA availability of a draft guidance for ODTs.
or the public. You can use an alternative industry entitled ‘‘Bioequivalence Clozapine tablets, marketed under the
approach if it satisfies the requirements Recommendations for Clozapine,’’ for name CLOZARIL, are the subject of new
of the applicable statutes and the orally disintegrating tablets (ODTs). drug application (NDA) 19–758, held by
regulations. The recommendations provide specific Novartis Pharmaceuticals Corporation
III. Paperwork Reduction Act of 1995 guidance on the design of and approved by FDA on September 26,
bioequivalence (BE) studies to support 1989. FazaClo ODTs were approved by
This guidance refers to previously
abbreviated new drug applications FDA on February 19, 2004, under NDA
approved collections of information
(ANDAs) for clozapine ODTs. 21–590, currently held by Jazz
found in FDA regulations. These
collections of information are subject to DATES: Although you can comment on Pharmaceuticals III International LTD,
review by the Office of Management and any guidance at any time (see 21 CFR based upon a finding that FazaClo ODTs
Budget (OMB) under the Paperwork 10.115(g)(5)), to ensure that the Agency were bioequivalent to CLOZARIL
Reduction Act of 1995 (44 U.S.C. 3501– considers your comment on the draft immediate-release tablets. FazaClo
3520). The collections of information in guidance before it begins work on the ODTs are available as yellow, orally
21 CFR part 514 have been approved final version of the guidance, submit disintegrating tablets of 12.5, 25, 100,
under OMB control number 0910–0032. either electronic or written comments 150, and 200 1 milligrams (mg) of
The collections of information in on the draft guidance by July 6, 2015. clozapine for oral administration
section 512(n)(1) of the FD&C Act have ADDRESSES: Submit written requests for without water. They are formulated to
been approved under OMB control single copies of the draft guidance to the disintegrate once exposed to saliva and
number 0910–0669. Division of Drug Information, Center for then are easily swallowed.
Drug Evaluation and Research, Food In June 2005, FDA published a
IV. Comments and Drug Administration, 10001 New guidance for industry entitled
Interested persons may submit either Hampshire Ave., Hillandale Building, ‘‘Clozapine Tablets: In Vivo
electronic comments regarding this 4th Floor, Silver Spring, MD 20993– Bioequivalence and In Vitro Dissolution
document to http://www.regulations.gov 0002. Send one self-addressed adhesive Testing’’ (Clozapine Guidance) (70 FR
or written comments to the Division of label to assist that office in processing 35447, June 20, 2005), which replaced a
Dockets Management (see ADDRESSES). It your requests. See the SUPPLEMENTARY 1996 product-specific bioequivalence
tkelley on DSK3SPTVN1PROD with NOTICES
is only necessary to send one set of INFORMATION section for electronic guidance for clozapine tablets. The 2005
comments. Identify comments with the access to the draft guidance documents. Clozapine Guidance recommends that
docket number found in brackets in the Submit electronic comments on the ANDA applicants employ multiple-
heading of this document. Received draft guidance to http:// dose, steady-state studies to evaluate the
comments may be seen in the Division www.regulations.gov. Submit written
of Dockets Management between 9 a.m. comments to the Division of Dockets 1 FDA approved the supplemental NDA for the
and 4 p.m., Monday through Friday, and Management (HFA–305), Food and Drug 150 and 200 mg strengths on July 9, 2010.
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Document Created: 2015-12-16 07:41:23
Document Modified: 2015-12-16 07:41:23
| 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 Agency guidances at any time. | |
| Contact | Katherine Weld, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0846, [email protected] | |
| FR Citation | 80 FR 26062 |
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