80 FR 46019 - Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 148 (August 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 148 (August 3, 2015)
| Page Range | 46019-46020 | |
| FR Document | 2015-18968 |
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)] [Notices] [Pages 46019-46020] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18968] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1997-D-0187] Dissolution Testing and Specification Criteria for Immediate- Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.'' This draft guidance has been developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/ or abbreviated new drug applications (ANDAs), as appropriate, for immediate-release (IR) tablets and capsules that contain highly soluble drug substances. The draft guidance is intended to define when a standard release test and criteria may be used in lieu of extensive method development and specification-setting exercises. When final, this guidance will supersede the guidance for industry on ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms'' (August 1997) for biopharmaceutics classification system (BCS) class 1 and 3 drug substances that meet the criteria in this draft guidance. For class 2 and 4 drug substances, applicants should still refer to the August 1997 guidance mentioned previously. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 2, 2015. ADDRESSES: Submit written requests for single copies of the draft 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 draft guidance document. Submit electronic comments on the draft 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: Richard Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 301-796-1667. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.'' Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilization of the drug under physiological conditions, and the permeation across the gastrointestinal membrane. NDAs and ANDAs submitted to FDA contain bioavailability (BA) or bioequivalence (BE) data and in vitro dissolution data that, together with chemistry, manufacturing, and controls (CMC) data, characterize the quality and performance of the drug product. In vitro dissolution data are generally obtained from batches that have been used in pivotal clinical and/or bioavailability studies and from other human studies conducted during product development. Knowledge about the solubility, permeability, dissolution, and pharmacokinetics of a drug product is considered when defining dissolution test specifications for the drug approval process. The BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. The definitions of high and low solubility and high and low permeability are used as described in FDA's Biopharmaceutics Classification System (BCS) Guidance. The different classifications are: Class 1: High Solubility--High Permeability Drugs Class 2: Low Solubility--High Permeability Drugs Class 3: High Solubility--Low Permeability Drugs Class 4: Low Solubility--Low Permeability Drugs This classification can be used as a basis for determining when in vivo bioavailability and bioequivalence studies are needed and can be used to determine when a successful in vivo-in vitro correlation (IVIVC) is likely. The BCS suggests that, for certain high solubility drugs, dissolution testing can be standardized or may not be needed. Owing to their high solubility, BCS class 1 and 3 drugs are considered to be relatively low risk regarding the impact of dissolution on performance, provided the in vitro performance meets or exceeds the recommendations discussed in the guidance. [[Page 46020]] This draft guidance establishes standard dissolution methodology and specifications that are appropriate for BCS class 1 and class 3 drugs. The availability of these standards will facilitate the rapid development of dissolution methodology and related specifications for these classes during drug development and application review. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. 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. III. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that 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 parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. IV. 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: July 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-18968 Filed 7-31-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46019
payment. The Pay.gov feature is guidance for industry entitled I. Background
available on the FDA Web site after ‘‘Dissolution Testing and Specification FDA is announcing the availability of
completing the Generic Drug User Fee Criteria for Immediate-Release Solid a draft guidance for industry entitled
Cover Sheet and generating the user fee Oral Dosage Forms Containing ‘‘Dissolution Testing and Specification
ID number. Biopharmaceutics Classification System Criteria for Immediate-Release Solid
Please include the user fee ID number Class 1 and 3 Drugs.’’ This draft Oral Dosage Forms Containing
on your check, bank draft, or postal guidance has been developed to provide Biopharmaceutics Classification System
money order and make payable to the manufacturers with recommendations Class 1 and 3 Drugs.’’ Drug absorption
order of the Food and Drug for submission of new drug applications from a solid dosage form after oral
Administration. Your payment can be (NDAs), investigational new drug administration depends on the release
mailed to: Food and Drug applications (INDs), and/or abbreviated of the drug substance from the drug
Administration, P.O. Box 979108, St. new drug applications (ANDAs), as product, the dissolution or
Louis, MO 63197–9000. If checks are to appropriate, for immediate-release (IR) solubilization of the drug under
be sent by a courier that requests a street tablets and capsules that contain highly physiological conditions, and the
address, the courier can deliver checks soluble drug substances. The draft permeation across the gastrointestinal
to: U.S. Bank, Attention: Government guidance is intended to define when a membrane. NDAs and ANDAs
Lockbox 979108, 1005 Convention standard release test and criteria may be submitted to FDA contain
Plaza, St. Louis, MO 63101. (Note: This used in lieu of extensive method bioavailability (BA) or bioequivalence
U.S. Bank address is for courier delivery development and specification-setting (BE) data and in vitro dissolution data
only.) Please make sure that the FDA exercises. When final, this guidance will that, together with chemistry,
post office box number (P.O. Box supersede the guidance for industry on manufacturing, and controls (CMC)
979108) is written on the check, bank ‘‘Dissolution Testing of Immediate data, characterize the quality and
draft, or postal money order. Release Solid Oral Dosage Forms’’ performance of the drug product. In
If paying by wire transfer, please (August 1997) for biopharmaceutics vitro dissolution data are generally
reference your unique user fee ID classification system (BCS) class 1 and obtained from batches that have been
number when completing your transfer. 3 drug substances that meet the criteria used in pivotal clinical and/or
The originating financial institution in this draft guidance. For class 2 and bioavailability studies and from other
may charge a wire transfer fee. Please 4 drug substances, applicants should human studies conducted during
ask your financial institution about the still refer to the August 1997 guidance product development. Knowledge about
wire transfer fee and include it with mentioned previously. the solubility, permeability, dissolution,
your payment to ensure that your fee is
DATES: Although you can comment on and pharmacokinetics of a drug product
fully paid. The account information is
any guidance at any time (see 21 CFR is considered when defining dissolution
as follows: New York Federal Reserve
10.115(g)(5)), to ensure that the Agency test specifications for the drug approval
Bank, U.S. Department of Treasury,
considers your comment on this draft process.
TREAS NYC, 33 Liberty St., New York,
guidance before it begins work on the The BCS is a scientific framework for
NY 10045, account number: 75060099,
final version of the guidance, submit classifying drug substances based on
routing number: 021030004, SWIFT:
either electronic or written comments their aqueous solubility and intestinal
FRNYUS33, Beneficiary: FDA, 8455
on the draft guidance by October 2, permeability. The definitions of high
Colesville Rd., Silver Spring, MD
2015. and low solubility and high and low
20993–0002. The tax identification
permeability are used as described in
number of FDA is 53–0196965.
ADDRESSES: Submit written requests for FDA’s Biopharmaceutics Classification
Dated: July 28, 2015. single copies of the draft guidance to the System (BCS) Guidance. The different
Leslie Kux, Division of Drug Information, Center for classifications are:
Associate Commissioner for Policy. Drug Evaluation and Research, Food Class 1: High Solubility—High
[FR Doc. 2015–18915 Filed 7–31–15; 8:45 am] and Drug Administration, 10001 New Permeability Drugs
BILLING CODE 4164–01–P Hampshire Ave., Hillandale Building, Class 2: Low Solubility—High
4th Floor, Silver Spring, MD 20993– Permeability Drugs
0002. Send one self-addressed adhesive Class 3: High Solubility—Low
DEPARTMENT OF HEALTH AND label to assist that office in processing Permeability Drugs
HUMAN SERVICES your requests. See the SUPPLEMENTARY Class 4: Low Solubility—Low
INFORMATION section for electronic Permeability Drugs
Food and Drug Administration access to the draft guidance document.
This classification can be used as a
[Docket No. FDA–1997–D–0187] Submit electronic comments on the basis for determining when in vivo
draft guidance to http:// bioavailability and bioequivalence
Dissolution Testing and Specification www.regulations.gov. Submit written studies are needed and can be used to
Criteria for Immediate-Release Solid comments to the Division of Dockets determine when a successful in vivo-in
Oral Dosage Forms Containing Management (HFA–305), Food and Drug vitro correlation (IVIVC) is likely. The
Biopharmaceutics Classification Administration, 5630 Fishers Lane, Rm. BCS suggests that, for certain high
System Class 1 and 3 Drugs; Draft 1061, Rockville, MD 20852. solubility drugs, dissolution testing can
Guidance for Industry; Availability
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
be standardized or may not be needed.
AGENCY: Food and Drug Administration, Richard Lostritto, Center for Drug Owing to their high solubility, BCS class
HHS. 1 and 3 drugs are considered to be
Evaluation and Research, Food and
ACTION: Notice. relatively low risk regarding the impact
Drug Administration, 10903 New
of dissolution on performance, provided
Hampshire Avenue, Silver Spring, MD
SUMMARY: The Food and Drug the in vitro performance meets or
20993, 301–796–1667.
Administration (FDA or Agency) is exceeds the recommendations discussed
announcing the availability of a draft SUPPLEMENTARY INFORMATION: in the guidance.
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![46020 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
This draft guidance establishes Dated: July 29, 2015. 100 percent of the costs of each activity
standard dissolution methodology and Leslie Kux, for each year (sections 743(b)(2)(A)(i),
specifications that are appropriate for Associate Commissioner for Policy. (ii), and (iv)), and these fees must be
BCS class 1 and class 3 drugs. The [FR Doc. 2015–18968 Filed 7–31–15; 8:45 am] made available solely to pay for the
availability of these standards will BILLING CODE 4164–01–P costs of each activity for which the fee
facilitate the rapid development of was incurred (section 743(b)(3)). These
dissolution methodology and related fees are effective on October 1, 2015,
specifications for these classes during DEPARTMENT OF HEALTH AND and will remain in effect through
drug development and application HUMAN SERVICES September 30, 2016. Section
review. 743(b)(2)(B)(iii) of the FD&C Act directs
Food and Drug Administration
This draft guidance is being issued FDA to develop a proposed set of
consistent with FDA’s good guidance [Docket No. FDA–2015–N–0007] guidelines in consideration of the
practices regulation (21 CFR 10.115). burden of fee amounts on small
Food Safety Modernization Act businesses. As a first step in developing
The draft guidance, when finalized, will Domestic and Foreign Facility
represent the Agency’s current thinking these guidelines, FDA invited public
Reinspection, Recall, and Importer comment on the potential impact of the
on Dissolution Testing and Reinspection Fee Rates for Fiscal Year
Specification Criteria for Immediate- fees authorized by section 743 of the
2016
Release Solid Oral Dosage Forms FD&C Act on small businesses (76 FR
Containing Biopharmaceutics AGENCY: Food and Drug Administration, 45818, August 1, 2011). The comment
Classification System Class 1 and 3 HHS. period for this request ended November
Drugs. It does not create or confer any ACTION: Notice. 30, 2011. As stated in FDA’s September
rights for or on any person and does not 2011 ‘‘Guidance for Industry:
SUMMARY: The Food and Drug Implementation of the Fee Provisions of
operate to bind FDA or the public. An Administration (FDA) is announcing the
alternative approach may be used if Section 107 of the FDA Food Safety
fiscal year (FY) 2016 fee rates for certain Modernization Act,’’ (http://
such approach satisfies the domestic and foreign facility
requirements of the applicable statutes www.fda.gov/Food/Guidance
reinspections, failures to comply with a
and regulations. Regulation/GuidanceDocuments
recall order, and importer reinspections
that are authorized by the Federal Food, RegulatoryInformation/FoodDefense/
II. Comments ucm274176.htm), because FDA
Drug, and Cosmetic Act (the FD&C Act),
as amended by the FDA Food Safety recognizes that for small businesses the
Interested persons may submit either
Modernization Act (FSMA). These fees full cost recovery of FDA reinspection
electronic comments regarding this
are effective on October 1, 2015, and or recall oversight could impose severe
document to http://www.regulations.gov
will remain in effect through September economic hardship, FDA intends to
or written comments to the Division of
30, 2016. consider reducing certain fees for those
Dockets Management (see ADDRESSES). It
is only necessary to send one set of FOR FURTHER INFORMATION CONTACT: firms. FDA does not intend to issue
comments. Identify comments with the Jason Lewis, Office of Resource invoices for reinspection or recall order
docket number found in brackets in the Management, Office of Regulatory fees until FDA publishes a guidance
heading of this document. Received Affairs, Food and Drug Administration, document outlining the process through
comments may be seen in the Division 12420 Parklawn Dr., Rm. 2046, which firms may request a reduction in
of Dockets Management between 9 a.m. Rockville, MD 20857, 301–796–5957, fees.
and 4 p.m., Monday through Friday, and email: Jason.Lewis@fda.hhs.gov. In addition, as stated in the
will be posted to the docket at http:// SUPPLEMENTARY INFORMATION: September 2011 Guidance, FDA is in
www.regulations.gov. I. Background the process of considering various
issues associated with the assessment
III. The Paperwork Reduction Act of Section 107 of FSMA (Pub. L. 111– and collection of importer reinspection
1995 353) added section 743 to the FD&C Act fees. The fee rates set forth in this notice
(21 U.S.C. 379j–31) to provide FDA with
This draft guidance refers to will be used to determine any importer
the authority to assess and collect fees
previously approved collections of reinspection fees assessed in FY 2016.
from, in part: (1) The responsible party
information that are subject to review by for each domestic facility and the U.S. II. Estimating the Average Cost of a
the Office of Management and Budget agent for each foreign facility subject to Supported Direct FDA Work Hour for
(OMB) under the Paperwork Reduction a reinspection, to cover reinspection- FY 2016
Act of 1995 (44 U.S.C. 3501–3520). The related costs; (2) the responsible party
collections of information in 21 CFR for a domestic facility and an importer FDA is required to estimate 100
parts 312 and 314 have been approved who does not comply with a recall percent of its costs for each activity in
under OMB control numbers 0910–0014 order, to cover food 1 recall activities order to establish fee rates for FY 2016.
and 0910–0001, respectively. associated with such order; and (3) each In each year, the costs of salary (or
importer subject to a reinspection to personnel compensation) and benefits
IV. Electronic Access cover reinspection-related costs for FDA employees account for between
mstockstill on DSK4VPTVN1PROD with NOTICES
(sections 743(a)(1)(A), (B), and (D) of the 50 and 60 percent of the funds available
Persons with access to the Internet
FD&C Act). Section 743 of the FD&C Act to, and used by, FDA. Almost all of the
may obtain the document at either
directs FDA to establish fees for each of remaining funds (operating funds)
http://www.fda.gov/Drugs/Guidance these activities based on an estimate of
ComplianceRegulatoryInformation/ available to FDA are used to support
Guidances/default.htm or http:// 1 The term ‘‘food’’ for purposes of this document
FDA employees for paying rent, travel,
www.regulations.gov. has the same meaning as such term in section 201(f)
utility, information technology, and
of the FD&C Act (21 U.S.C. 321(f)). other operating costs.
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Document Created: 2018-02-23 10:51:58
Document Modified: 2018-02-23 10:51:58
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 2, 2015. | |
| Contact | Richard Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 301-796-1667. | |
| FR Citation | 80 FR 46019 |
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