82 FR 4894 - Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 10 (January 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 10 (January 17, 2017)
| Page Range | 4894-4896 | |
| FR Document | 2017-00820 |
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)] [Notices] [Pages 4894-4896] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00820] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-0114] Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled [[Page 4895]] ``Referencing Approved Drug Products in ANDA Submissions.'' Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA submission. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 20, 2017. 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-2017-D-0114 for ``Referencing Approved Drug Products in ANDA Submissions.'' 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: 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 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 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. FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9291, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Referencing Approved Drug Products in ANDA Submissions.'' To obtain approval of an ANDA submitted under section 505(j) of the FD&C Act (21 U.S.C. 355(j)), an ANDA applicant generally must show, among other things, that the proposed generic drug has the same active ingredient(s), conditions of use, route of administration, dosage form, strength, and, with certain permissible differences, labeling as the specific listed drug referred to in the ANDA, i.e., the RLD. Under section 505(j)(2)(A)(iv) of the FD&C Act, the ANDA applicant also must demonstrate that the proposed generic drug is bioequivalent to the RLD and, if in vivo bioequivalence studies are required for approval of the ANDA, the applicant must use the reference standard selected by FDA in such testing (21 CFR 314.3(b)). Further, under section 505(j)(2)(A)(vi) of the FD&C Act, a generic drug must meet the same high standards of quality and manufacturing as drug products approved under section 505(c) of the FD&C Act. This guidance provides information to potential applicants on how to identify a ``reference listed drug,'' ``reference standard,'' and the ``basis of submission'' in ANDA submissions. A variety of factors has led to confusion among stakeholders on what these terms mean and how an ANDA applicant should use them. These factors include the discontinued marketing of many approved drug products and FDA's identification of reference standards with the RLD symbol (``+'') in the printed version, and under the ``RLD'' column in the electronic version, of FDA's ``Approved Drug Products with Therapeutic Equivalence Evaluations'' (the ``Orange Book''). This guidance is intended to address this confusion by explaining what these terms mean and clarifying the differences among them. This guidance provides [[Page 4896]] recommendations on how to accurately use these terms in an ANDA, how persons can request FDA designation of an RLD, and how persons can request FDA selection of a reference standard. 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 current thinking of FDA on Referencing Approved Drug Products in ANDA Submissions. 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 draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: January 11, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00820 Filed 1-13-17; 8:45 am] BILLING CODE 4164-01-P
![4894 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
or at the Division of Dockets Administration, Document Control guidance provides FDA’s interpretation
Management between 9 a.m. and 4 p.m., Center, 10903 New Hampshire Ave., of, and a compliance policy for, this
Monday through Friday. Bldg. 71, Rm. G335, Silver Spring, MD label requirement.
• Confidential Submissions—To 20993–0002, 1–877–287–1373, email: Retail establishments, such as vape
submit a comment with confidential AskCTP@fda.hhs.gov. shops, which engage in certain activities
information that you do not wish to be SUPPLEMENTARY INFORMATION: may also be subject to certain
made publicly available, submit your requirements of the FD&C Act that
comments only as a written/paper I. Background apply to tobacco product manufacturers
submission. You should submit two We are announcing the availability of and to establishments that engage in the
copies total. One copy will include the a draft guidance for industry entitled manufacture, preparation,
information you claim to be confidential ‘‘Interpretation of and Compliance compounding, or processing of tobacco
with a heading or cover note that states Policy for Certain Label Requirement; product. These activities may also
‘‘THIS DOCUMENT CONTAINS Applicability of Certain Federal Food, include modifying a product so that it
CONFIDENTIAL INFORMATION.’’ The Drug, and Cosmetic Act Requirements to is a new tobacco product requiring
Agency will review this copy, including Vape Shops.’’ compliance with the premarket
the claimed confidential information, in This draft guidance document, when authorization requirements. This draft
its consideration of comments. The finalized, will provide FDA’s guidance explains which activities
second copy, which will have the interpretation of, and a compliance subject vape shops to these FD&C Act
claimed confidential information policy for, the label requirement under requirements and the limited
redacted/blacked out, will be available section 903(a)(2)(C) of the FD&C Act (21 circumstances under which FDA does
for public viewing and posted on U.S.C. 387c(a)(2)(C)). This draft not intend to enforce compliance.
https://www.regulations.gov. Submit guidance document, when finalized, is
also intended to assist retailers who sell II. Significance of Guidance
both copies to the Division of Dockets
Management. If you do not wish your newly deemed products by explaining FDA is issuing this draft guidance
name and contact information to be whether engaging in certain activities consistent with FDA’s good guidance
made publicly available, you can subjects such establishments to practices regulation (21 CFR 10.115).
provide this information on the cover additional requirements of the FD&C The draft guidance, when finalized, will
sheet and not in the body of your Act and the limited circumstances represent the current thinking of FDA.
comments and you must identify this under which FDA does not intend to It does not establish any rights for any
information as ‘‘confidential.’’ Any enforce compliance. person and is not binding on FDA or the
information marked as ‘‘confidential’’ The Family Smoking Prevention and public. You can use an alternative
will not be disclosed except in Tobacco Control Act (Pub. L. 111–31) approach if it satisfies the requirements
accordance with 21 CFR 10.20 and other (Tobacco Control Act), enacted on June of the applicable statutes and
22, 2009, amends section 904 of the regulations.
applicable disclosure law. For more
FD&C Act (21 U.S.C. 387d) and provides
information about FDA’s posting of III. Electronic Access
FDA with the authority to regulate the
comments to public dockets, see 80 FR
manufacture, marketing, and Persons with access to the Internet
56469, September 18, 2015, or access
distribution of tobacco products to may obtain an electronic version of the
the information at: http://www.fda.gov/
protect the public health generally and draft guidance at either https://
regulatoryinformation/dockets/
to reduce tobacco use by minors. www.regulations.gov or http://
default.htm. Cigarettes, cigarette tobacco, roll-your-
Docket: For access to the docket to www.fda.gov/TobaccoProducts/
own tobacco, and smokeless tobacco Labeling/RulesRegulationsGuidance/
read background documents or the were immediately covered by FDA’s
electronic and written/paper comments default.htm.
tobacco product authorities in chapter
received, go to https:// Dated: January 9, 2017.
IX of the FD&C Act, when the Tobacco
www.regulations.gov and insert the Control Act went into effect. As for Leslie Kux,
docket number, found in brackets in the other types of tobacco products, section Associate Commissioner for Policy.
heading of this document, into the 901(b) of the FD&C Act (21 U.S.C. [FR Doc. 2017–00773 Filed 1–13–17; 8:45 am]
‘‘Search’’ box and follow the prompts 387a(b)) grants FDA authority to deem BILLING CODE 4164–01–P
and/or go to the Division of Dockets those products subject to chapter IX of
Management, 5630 Fishers Lane, Rm. the FD&C Act. Under that authority,
1061, Rockville, MD 20852. FDA issued a rule deeming all other DEPARTMENT OF HEALTH AND
Submit written requests for single products that meet the statutory HUMAN SERVICES
copies of the draft guidance to the definition of ‘‘tobacco product,’’ set
Center for Tobacco Products, Food and Food and Drug Administration
forth in section 201(rr) of the FD&C Act
Drug Administration, Document Control (21 U.S.C. 321(rr)), except for [Docket No. FDA–2017–D–0114]
Center, Bldg. 71, Rm. G335, 10903 New accessories of those products, as subject
Hampshire Ave., Silver Spring, MD to chapter IX of the FD&C Act (81 FR Referencing Approved Drug Products
20993–0002. Send one self-addressed 28974). FDA published the final rule on in Abbreviated New Drug Application
adhesive label to assist that office in May 10, 2016, and it became effective Submissions; Draft Guidance for
processing your request or include a fax on August 8, 2016. Industry; Availability
number to which the guidance Section 903(a)(2)(C) of the FD&C Act
sradovich on DSK3GMQ082PROD with NOTICES
document may be sent. See the AGENCY: Food and Drug Administration,
provides that a tobacco product in HHS.
SUPPLEMENTARY INFORMATION section for package form is misbranded unless its
electronic access to the guidance ACTION: Notice of availability.
label contains ‘‘an accurate statement of
document. the percentage of tobacco used in the SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: product that is domestically grown Administration (FDA or Agency) is
Katherine Collins, Center for Tobacco tobacco and the percentage that is announcing the availability of a draft
Products, Food and Drug foreign grown tobacco.’’ The draft guidance for industry entitled
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![4896 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
recommendations on how to accurately variety of viewpoints, including from Instructions: All submissions received
use these terms in an ANDA, how competent authorities in other countries must include the Docket No. FDA–
persons can request FDA designation of and from private entities, to help inform 2016–N–4662 for ‘‘Public Hearing:
an RLD, and how persons can request FDA regarding risk-based Strategic Partnerships to Enhance the
FDA selection of a reference standard. decisionmaking, commodity-specific Safety of Imported Foods: Capacity
This draft guidance is being issued export control programs in other Building, Risk-Based Decisionmaking,
consistent with FDA’s good guidance countries, and systems recognition. Recognition of Commodity Food Control
practices regulation (21 CFR 10.115). DATES: See ‘‘How to Participate in the Programs, and Systems Recognition.’’
The draft guidance, when finalized, will Hearing’’ in the SUPPLEMENTARY Received comments will be placed in
represent the current thinking of FDA INFORMATION section of this document the docket and, except for those
on Referencing Approved Drug Products for dates and times of the public submitted as ‘‘Confidential
in ANDA Submissions. It does not meetings, closing dates for advance Submissions,’’ publicly viewable at
establish any rights for any person and registration, requesting special https://www.regulations.gov or at the
is not binding on FDA or the public. accommodations due to disability, Division of Dockets Management
You can use an alternative approach if closing date to submit comments to the between 9 a.m. and 4 p.m., Monday
it satisfies the requirements of the docket, and other information regarding through Friday.
applicable statutes and regulations. meeting participation. • Confidential Submissions—To
II. Electronic Access ADDRESSES: You may submit comments
submit a comment with confidential
as follows: information that you do not wish to be
Persons with access to the Internet made publicly available, submit your
may obtain the draft guidance at either Electronic Submissions comments only as a written/paper
http://www.fda.gov/Drugs/Guidance submission. You should submit two
ComplianceRegulatoryInformation/ Submit electronic comments in the
following way: copies total. One copy will include the
Guidances/default.htm or https://
• Federal eRulemaking Portal: information you claim to be confidential
www.regulations.gov.
https://www.regulations.gov. Follow the with a heading or cover note that states
Dated: January 11, 2017. ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments.
Leslie Kux, CONFIDENTIAL INFORMATION.’’ We
Comments submitted electronically,
Associate Commissioner for Policy. including attachments, to https:// will review this copy, including the
[FR Doc. 2017–00820 Filed 1–13–17; 8:45 am] www.regulations.gov will be posted to claimed confidential information, in our
BILLING CODE 4164–01–P the docket unchanged. Because your consideration of comments. The second
comment will be made public, you are copy, which will have the claimed
solely responsible for ensuring that your confidential information redacted/
DEPARTMENT OF HEALTH AND comment does not include any blacked out, will be available for public
HUMAN SERVICES confidential information that you or a viewing and posted on https://
third party may not wish to be posted, www.regulations.gov. Submit both
Food and Drug Administration copies to the Division of Dockets
such as medical information, your or
[Docket No. FDA–2016–N–4662] anyone else’s Social Security number, or Management. If you do not wish your
confidential business information, such name and contact information to be
Public Hearing: Strategic Partnerships as a manufacturing process. Please note made publicly available, you can
To Enhance the Safety of Imported that if you include your name, contact provide this information on the cover
Foods: Capacity Building, Risk-Based information, or other information that sheet and not in the body of your
Decisionmaking, Recognition of identifies you in the body of your comments and you must identify this
Commodity Food Control Programs, comments, that information will be information as ‘‘confidential.’’ Any
and Systems Recognition; Request for posted on https://www.regulations.gov. information marked as ‘‘confidential’’
Comments • If you want to submit a comment will not be disclosed except in
with confidential information that you accordance with 21 CFR 10.20 and other
AGENCY: Food and Drug Administration,
do not wish to be made available to the applicable disclosure law. For more
HHS.
public, submit the comment as a information about FDA’s posting of
ACTION:Notice of public hearing; request comments to public dockets, see 80 FR
for comments. written/paper submission and in the
manner detailed (see ‘‘Written/Paper 56469, September 18, 2015, or access
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). the information at: http://www.fda.gov/
Administration (FDA or we) is regulatoryinformation/dockets/
announcing a public hearing regarding Written/Paper Submissions default.htm.
FDA initiatives for enhancing the safety Submit written/paper submissions as Docket: For access to the docket to
of foods (for humans and animals) follows: read background documents or the
imported into the United States. The • Mail/Hand delivery/Courier (for electronic and written/paper comments
hearing will focus on partnerships to written/paper submissions): Division of received, go to https://
improve safety capabilities through Dockets Management (HFA–305), Food www.regulations.gov and insert the
capacity building; partnerships that and Drug Administration, 5630 Fishers docket number, found in brackets in the
incorporate information from private Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the
entities and foreign competent • For written/paper comments ‘‘Search’’ box and follow the prompts
sradovich on DSK3GMQ082PROD with NOTICES
authorities to inform risk-based submitted to the Division of Dockets and/or go to the Division of Dockets
decisionmaking; partnerships that Management, FDA will post your Management, 5630 Fishers Lane, Rm.
recognize commodity-specific export comment, as well as any attachments, 1061, Rockville, MD 20852.
programs; and partnerships that except for information submitted, FOR FURTHER INFORMATION CONTACT:
recognize the robustness of a nation’s marked and identified, as confidential, Wade Woolfolk, Food and Drug
entire food safety system. In addition, if submitted as detailed in Administration, Center for Food Safety
we are seeking information from a ‘‘Instructions.’’ and Applied Nutrition (HFS–550), 5001
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Document Created: 2017-01-14 01:44:52
Document Modified: 2017-01-14 01:44:52
| 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 | 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 March 20, 2017. | |
| Contact | Gail Schmerfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9291, [email protected] | |
| FR Citation | 82 FR 4894 |
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