Competitive Generic Therapies; Draft Guidance for Industry; Availability, 4826-4828 [2019-02598]

Download as PDF 4826 Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: tkelley on DSKBCP9HB2PROD with NOTICES I. Background FDA is announcing the availability of a document entitled ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry.’’ The guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or lifethreatening diseases or conditions (referred to in the guidance as serious conditions), including those products designated as RMATs; provides information about the provisions in the 21st Century Cures Act (Cures Act) (Pub. L. 114–225) regarding the use of the accelerated approval pathway for regenerative medicine therapies that have been granted designation as an RMAT; describes how CBER will encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies that are being developed to address unmet needs in patients with serious conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff. VerDate Sep<11>2014 17:46 Feb 15, 2019 Jkt 247001 In the Federal Register of November 17, 2017 (82 FR 54385), FDA announced the availability of the draft guidance of the same title dated November 2017. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated November 2017. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled ‘‘Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry.’’ 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 ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.’’ 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. This guidance is not subject to Executive Order 12866. II. 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 312 have been approved under OMB control number 0910–0014; the collections of information regarding formal meetings described in the draft guidance, ’’Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,’’ have been approved under OMB control number 0910–0429; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338; the collections of information for expedited programs in ’’Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics,’’ have been approved under OMB control number 0910–0765; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 default.htm or https:// www.regulations.gov. Dated: February 13, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–02691 Filed 2–15–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–0065] Competitive Generic Therapies; Draft Guidance for Industry; 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 draft guidance for industry entitled ‘‘Competitive Generic Therapies.’’ On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a section was added to the FD&C Act that established a new process to designate, and expedite the development and review of, certain drugs intended for submission or submitted in an abbreviated new drug application (ANDA) and for which there is ‘‘inadequate generic competition.’’ This draft guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. This draft guidance also includes information on the actions FDA may take to expedite the development and review of an ANDA for a drug designated as a CGT. This draft guidance also provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as CGTs. DATES: Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\19FEN1.SGM 19FEN1 Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices tkelley on DSKBCP9HB2PROD with NOTICES • 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2019–D–0065 for ‘‘Competitive Generic Therapies.’’ 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 Dockets Management Staff 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 VerDate Sep<11>2014 17:46 Feb 15, 2019 Jkt 247001 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 Dockets Management Staff. 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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: Susan Levine, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993–0002, 240– 402–7936. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Competitive Generic Therapies.’’ On August 18, 2017, FDARA (Pub. L. 115– 52) was signed into law. As part of FDARA, the Generic Drug User Fee Amendments were reauthorized (Title III) to continue timely access to highquality affordable generic medicines. FDARA also created other PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 4827 enhancements associated with generic drugs. Specifically, section 803 of FDARA amended the FD&C Act to add section 506H (21 U.S.C. 356h), which established a new process to designate, and expedite the development and review of, certain drugs intended for submission or submitted in an ANDA and for which there is ‘‘inadequate generic competition.’’ FDA recognizes that various factors may influence a generic drug applicant’s decision to develop a certain drug. For instance, some drugs may not attract a high level of interest from generic drug applicants if there is a limited market for the products and/or if the products are more difficult to develop. Nevertheless, these drugs can play an important role in diagnosing, treating, and preventing various types of diseases or conditions, and incentivizing generic competition for these products can help ensure patients have access to the medicines they need. The provisions associated with CGTs are intended to incentivize effective development, efficient review, and timely market entry for drugs for which there is inadequate generic competition. This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. This guidance also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGT. These actions may help to clarify the regulatory expectations for a particular drug, assist applicants in developing a more complete submission, and ultimately promote a more efficient and effective ANDA review process and help reduce the number of review cycles necessary to obtain ANDA approval. This guidance also provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. FDARA created a new type of 180-day exclusivity, different from 180-day patent challenge exclusivity, for the first approved applicant of a drug with a CGT designation for which there were no unexpired patents or exclusivities listed in the Orange Book at the time of original submission of the ANDA. This new 180-exclusivity under FDARA (‘‘CGT exclusivity’’) is intended to incentivize competition for drugs that are not protected by patent or exclusivity and for which there is inadequate generic competition. This draft guidance is being issued consistent with FDA’s good guidance E:\FR\FM\19FEN1.SGM 19FEN1 4828 Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Competitive Generic Therapies.’’ 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. This guidance is not subject to Executive Order 12866. II. 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 314.94, including the submission of ANDAs and designations such as CGT product development, have been approved under OMB control number 0910–0001 (including 0910–0338 for Form FDA 356h). The collections of information associated with product development meetings, presubmission meetings, and mid-review cycle meetings between applicants and FDA have been approved under OMB control number 0910–0797. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: February 12, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–02598 Filed 2–15–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1093] tkelley on DSKBCP9HB2PROD with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:46 Feb 15, 2019 Jkt 247001 The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 21, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0546. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Food Additive Petitions and Investigational Food Additive Exemptions—21 CFR 570.17, 571.1, and 571.6 OMB Control Number 0910–0546— Extension Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the FD&C Act (21 U.S.C. 348(b)) specifies the information that must be submitted by a petitioner to establish the safety of a food additive and to secure the issuance of a regulation permitting its use. To implement the provisions of § 409 of the FD&C Act, we issued procedural regulations under 21 CFR part 571. These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 broader terms by the FD&C Act. The regulations add no substantive requirements to those indicated in the FD&C Act, but attempt to explain these requirements and provide a standard format for submission to speed processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in 21 CFR parts 501, 573, and 579. The labeling regulations are considered by FDA to be crossreferenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions. Regarding the investigational use of food additives, § 409(j) of the FD&C Act (§ 409(j)) (21 U.S.C. 348(j)) provides that any food additive, or any food bearing or containing such an additive, may be exempted from the requirements of this section if intended solely for investigational use by qualified experts. Investigational use of a food additive is typically to address the safety and/or intended physical or technical effect of the additive. To implement the provisions of § 409(j), we issued regulations under 21 CFR 570.17. These regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broad terms by the FD&C Act. Labeling requirements for investigational food additives are also set forth in various regulations contained in 21 CFR 501. The labeling regulations are considered by FDA to be cross-referenced to § 570.17, which is the subject of this same OMB clearance for investigational food additive files. The information collected is necessary to protect the public health. We use the information submitted by food manufacturers or food additive manufacturers to ascertain whether the data establish the identity of the substance, justify its intended effect in/ on the food, and establish that its intended use in/on food is safe. Description of Respondents: Respondents to this collection of information are food manufacturers or food additive manufacturers. In the Federal Register of August 3, 2018 (83 FR 38149), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4826-4828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02598]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0065]

Competitive Generic Therapies; 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
``Competitive Generic Therapies.'' On August 18, 2017, the FDA
Reauthorization Act of 2017 (FDARA), which amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a
section was added to the FD&C Act that established a new process to
designate, and expedite the development and review of, certain drugs
intended for submission or submitted in an abbreviated new drug
application (ANDA) and for which there is ``inadequate generic
competition.'' This draft guidance provides a description of the
process that applicants should follow to request designation of a drug
as a competitive generic therapy (CGT) and the criteria for designating
a drug as a CGT. This draft guidance also includes information on the
actions FDA may take to expedite the development and review of an ANDA
for a drug designated as a CGT. This draft guidance also provides
information on how FDA implements the statutory provisions providing
for a 180-day exclusivity period for certain first approved applicants
that submit ANDAs for drugs designated as CGTs.

DATES: Submit either electronic or written comments on the draft
guidance by April 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

Submit electronic comments in the following way:

[[Page 4827]]

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2019-D-0065 for ``Competitive Generic Therapies.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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: Susan Levine, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Competitive Generic Therapies.'' On August 18, 2017, FDARA
(Pub. L. 115-52) was signed into law. As part of FDARA, the Generic
Drug User Fee Amendments were reauthorized (Title III) to continue
timely access to high-quality affordable generic medicines. FDARA also
created other enhancements associated with generic drugs. Specifically,
section 803 of FDARA amended the FD&C Act to add section 506H (21
U.S.C. 356h), which established a new process to designate, and
expedite the development and review of, certain drugs intended for
submission or submitted in an ANDA and for which there is ``inadequate
generic competition.''
FDA recognizes that various factors may influence a generic drug
applicant's decision to develop a certain drug. For instance, some
drugs may not attract a high level of interest from generic drug
applicants if there is a limited market for the products and/or if the
products are more difficult to develop. Nevertheless, these drugs can
play an important role in diagnosing, treating, and preventing various
types of diseases or conditions, and incentivizing generic competition
for these products can help ensure patients have access to the
medicines they need. The provisions associated with CGTs are intended
to incentivize effective development, efficient review, and timely
market entry for drugs for which there is inadequate generic
competition.
This guidance provides a description of the process that applicants
should follow to request designation of a drug as a CGT and the
criteria for designating a drug as a CGT. This guidance also includes
information on the actions FDA may take to expedite the development and
review of ANDAs for drugs designated as CGT. These actions may help to
clarify the regulatory expectations for a particular drug, assist
applicants in developing a more complete submission, and ultimately
promote a more efficient and effective ANDA review process and help
reduce the number of review cycles necessary to obtain ANDA approval.
This guidance also provides information on how FDA implements the
statutory provisions providing for a 180-day exclusivity period for
certain first approved applicants that submit ANDAs for CGTs. FDARA
created a new type of 180-day exclusivity, different from 180-day
patent challenge exclusivity, for the first approved applicant of a
drug with a CGT designation for which there were no unexpired patents
or exclusivities listed in the Orange Book at the time of original
submission of the ANDA. This new 180-exclusivity under FDARA (``CGT
exclusivity'') is intended to incentivize competition for drugs that
are not protected by patent or exclusivity and for which there is
inadequate generic competition.
This draft guidance is being issued consistent with FDA's good
guidance

[[Page 4828]]

practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Competitive
Generic Therapies.'' 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. This guidance is not subject to Executive Order 12866.

II. 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 314.94, including the
submission of ANDAs and designations such as CGT product development,
have been approved under OMB control number 0910-0001 (including 0910-
0338 for Form FDA 356h). The collections of information associated with
product development meetings, presubmission meetings, and mid-review
cycle meetings between applicants and FDA have been approved under OMB
control number 0910-0797.

III. Electronic Access

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

Dated: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02598 Filed 2-15-19; 8:45 am]
BILLING CODE 4164-01-P

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