82 FR 4890 - Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability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 | 4890-4892 | |
| FR Document | 2017-00795 |
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)] [Notices] [Pages 4890-4892] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00795] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-4412] Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance March 20, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food [[Page 4891]] 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-2016-D-4412 for ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Andrew LeBoeuf, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240- 402-0503, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the Hatch-Waxman Amendments) created, among other things, section 505(j) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)). Under section 505(j) of the FD&C Act, an ANDA applicant can rely on FDA's previous finding that the reference listed drug (RLD) is safe and effective so long as the ANDA applicant demonstrates that the proposed drug product and the RLD are the same with respect to active ingredient(s), dosage form, route of administration, strength, and, with certain exceptions, labeling. An ANDA must also include sufficient information to demonstrate that the proposed product is bioequivalent to the RLD, and that the ANDA meets the approval requirements relating to chemistry, manufacturing, and controls. An ANDA generally is not required to be the same as the listed drug it references in certain respects. For example, a generic drug generally can differ from its RLD in certain respects with regard to the device or with respect to inactive ingredients. Drug products that meet the approval requirements under section 505(j) of the FD&C Act are generally considered by FDA to be therapeutically equivalent to their RLD. Products classified as therapeutically equivalent can be substituted with the full expectation that the generic product will produce the same clinical effect and safety profile as the RLD under the conditions specified in the labeling. These general principles apply to products submitted in ANDAs, including drug-device combination products. A generic drug-device combination product classified as therapeutically equivalent to the RLD can be expected to produce the same clinical effect and safety profile as the RLD under the conditions specified in labeling. This does not mean, however, that the proposed generic drug-device combination product and its RLD need to be identical in all respects. FDA recognizes that an identical design may not always be feasible and, in certain instances, differences in the design of the user interface for a generic drug-device combination product as compared to the RLD may exist without precluding approval of the generic combination drug- device product under an ANDA. In some instances in which differences exist, certain additional information and/or data relating to the user- interface of the proposed generic drug-device combination product, such as data from comparative use human factors studies, may be appropriate to support approval of the proposed product in an ANDA. The extent to which differences between the proposed product and the RLD affect the approvability of the proposed ANDA product will be evaluated on a case- by-case basis. This draft guidance provides general principles, including recommendations on threshold analyses, which are intended to assist potential applicants in the identification and the assessment of differences in the design of the user interface of a proposed generic drug-device combination product when compared to the user interface for its RLD. This draft guidance also provides recommendations on the design and conduct of comparative use human factors studies that may help applicants determine whether design differences identified between the proposed generic drug-device combination product and its RLD would preclude approval as an ANDA under the FD&C Act. 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 ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug- Device Combination Product Submitted in an ANDA.'' It does not establish any rights for any [[Page 4892]] 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 http://www.regulations.gov. Dated: January 10, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00795 Filed 1-13-17; 8:45 am] BILLING CODE 4164-01-P
![4890 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
two be combined by creating a P&A advocacy, collaboration with other functioning. The combined PPR and
Protection and Advocacy Annual federally-funded entities, and identify SGP allow federal staff to review the
Program Performance Report and best practices for efficient use of federal same information from the programs in
Statement of Goals and Priorities form. funds. a streamlined format that reduces the
By combining the forms, P&As will have Comments in Response to the 60 Day need to reenter the same information
a reduced burden because they will only Federal Register Notice multiple times. ACL does not plan to
have to submit one annual report. The make any changes in the data collection
combined form will also allow federal A notice was published in the Federal based on these comments.
reviewers to analyze patterns more Register in Vol. 81, No. 57592 on
August 23, 2016, announcing that ACL SUPPLEMENTARY INFORMATION: In
readily between goals and priority compliance with the requirements of
setting and program performance. was requesting approval of a data
collection (ICR New). ACL received two Section 506(c)(2)(A) of the Paperwork
The annual PPR and SGP are comments expressing concern that the Reduction Act of 1995, the
reviewed by federal staff for compliance combination of the SGP and PPR Administration on Community Living is
and outcomes. Information in the PPRs reporting forms would reduce the soliciting public comment on the
and SGPs is analyzed to create a overall oversight of the P&A program. burden related to the information
national profile of programmatic ACL responds that, while the reporting collection described above. The form is
compliance, outcomes, and goals and forms are being combined, the content available at: http://www.acl.gov/
priorities for P&A Systems for tracking which the grantees are reporting Programs/AIDD/Program_Resource_
accomplishments against goals and to remains the same, with the addition of Search/Results_PA.aspx.
formulate areas of technical assistance more quantitative measures to support Estimated Burden: The average
related to compliance with Federal the qualitative data that the grantees burden for the 57 Protection and
requirements and program performance. provide every year. The addition of Advocacy Systems i was calculated
Information collected in the unified more quantitative measures will provide based on consultations with selected
report will inform AIDD of trends in a fuller picture of how the programs are States.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Protection and Advocacy Annual Program Performance Report and State-
ment of Goals and Priorities ........................................................................ 57 1 75 4,275
Estimated Total Annual Burden ‘‘Comparative Analyses and Related including attachments, to http://
Hours: 4,275. Comparative Use Human Factors www.regulations.gov will be posted to
Dated: January 10, 2017. Studies for a Drug-Device Combination the docket unchanged. Because your
Edwin L. Walker, Product Submitted in an ANDA.’’ This comment will be made public, you are
draft guidance is intended to assist solely responsible for ensuring that your
Acting Administrator and Assistant Secretary
for Aging. potential applicants who plan to comment does not include any
develop and submit an abbreviated new confidential information that you or a
[FR Doc. 2017–00880 Filed 1–13–17; 8:45 am]
drug application (ANDA) to seek third party may not wish to be posted,
BILLING CODE 4154–01–P
approval of a generic combination such as medical information, your or
product that includes both a drug anyone else’s Social Security number, or
DEPARTMENT OF HEALTH AND constituent part and a delivery device confidential business information, such
HUMAN SERVICES constituent part. as a manufacturing process. Please note
DATES: Although you can comment on that if you include your name, contact
Food and Drug Administration any guidance at any time (see 21 CFR information, or other information that
10.115(g)(5)), to ensure that the Agency identifies you in the body of your
[Docket No. FDA–2016–D–4412] comments, that information will be
considers your comment on this draft
Comparative Analyses and Related guidance before it begins work on the posted on http://www.regulations.gov.
final version of the guidance, submit • If you want to submit a comment
Comparative Use Human Factors
either electronic or written comments with confidential information that you
Studies for a Drug-Device Combination
on the draft guidance March 20, 2017. do not wish to be made available to the
Product Submitted in an Abbreviated
public, submit the comment as a
New Drug Application; Draft Guidance ADDRESSES: You may submit comments written/paper submission and in the
for Industry; Availability as follows: manner detailed (see ‘‘Written/Paper
AGENCY: Food and Drug Administration, Electronic Submissions Submissions’’ and ‘‘Instructions’’).
HHS.
Submit electronic comments in the Written/Paper Submissions
ACTION: Notice of availability.
sradovich on DSK3GMQ082PROD with NOTICES
following way: Submit written/paper submissions as
SUMMARY: The Food and Drug • Federal eRulemaking Portal: http:// follows:
Administration (FDA or Agency) is www.regulations.gov. Follow the • Mail/Hand delivery/Courier (for
announcing the availability of a draft instructions for submitting comments. written/paper submissions): Division of
guidance for industry entitled Comments submitted electronically, Dockets Management (HFA–305), Food
i This number includes the 50 States, District of
Columbia, Puerto Rico and three Outlying Areas.
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![4892 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
person and is not binding on FDA or the DATES: Although you can comment on viewable at http://www.regulations.gov
public. You can use an alternative any guidance at any time (see 21 CFR or at the Division of Dockets
approach if it satisfies the requirements 10.115(g)(5)), to ensure that the Agency Management between 9 a.m. and 4 p.m.,
of the applicable statutes and considers your comment on this draft Monday through Friday.
regulations. guidance before it begins work on the • Confidential Submissions—To
II. Electronic Access final version of the guidance, submit submit a comment with confidential
either electronic or written comments information that you do not wish to be
Persons with access to the Internet on the draft guidance by February 16, made publicly available, submit your
may obtain the draft guidance at either 2017. comments only as a written/paper
http://www.fda.gov/Drugs/Guidance submission. You should submit two
ADDRESSES: You may submit comments
ComplianceRegulatoryInformation/ copies total. One copy will include the
Guidances/default.htm or http:// as follows:
information you claim to be confidential
www.regulations.gov. Electronic Submissions with a heading or cover note that states
Dated: January 10, 2017. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, following way: CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. • Federal eRulemaking Portal: http:// Agency will review this copy, including
[FR Doc. 2017–00795 Filed 1–13–17; 8:45 am] www.regulations.gov. Follow the the claimed confidential information, in
BILLING CODE 4164–01–P instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
including attachments, to http:// claimed confidential information
DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to redacted/blacked out, will be available
HUMAN SERVICES the docket unchanged. Because your for public viewing and posted on http://
comment will be made public, you are www.regulations.gov. Submit both
Food and Drug Administration solely responsible for ensuring that your copies to the Division of Dockets
[Docket No. FDA–2017–D–0121] comment does not include any Management. If you do not wish your
confidential information that you or a name and contact information to be
Compliance Policy for Required third party may not wish to be posted, made publicly available, you can
Warning Statements on Small- such as medical information, your or provide this information on the cover
Packaged Cigars; Draft Guidance for anyone else’s Social Security number, or sheet and not in the body of your
Industry; Availability confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
AGENCY: Food and Drug Administration, information marked as ‘‘confidential’’
that if you include your name, contact
HHS. will not be disclosed except in
information, or other information that
ACTION: Notice of availability. identifies you in the body of your accordance with 21 CFR 10.20 and other
SUMMARY: The Food and Drug comments, that information will be applicable disclosure law. For more
Administration (FDA) is announcing the posted on http://www.regulations.gov. information about FDA’s posting of
availability of a draft guidance for • If you want to submit a comment comments to public dockets, see 80 FR
industry entitled ‘‘Compliance Policy with confidential information that you 56469, September 18, 2015, or access
for Required Warning Statements on do not wish to be made available to the the information at: http://www.fda.gov/
Small-Packaged Cigars.’’ The draft public, submit the comment as a regulatoryinformation/dockets/
guidance, when finalized, is intended to written/paper submission and in the default.htm.
assist any person who manufacturers, manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
packages, sells, offers to sell, distributes, Submissions’’ and ‘‘Instructions’’). read background documents or the
or imports cigars in small packages, in electronic and written/paper comments
Written/Paper Submissions
complying with the warning statement received, go to http://
requirements in FDA’s regulations Submit written/paper submissions as www.regulations.gov and insert the
deeming all other products that meet the follows: docket number, found in brackets in the
statutory definition of a tobacco product • Mail/Hand delivery/Courier (for heading of this document, into the
to be subject to Chapter IX of the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Federal Food, Drug, and Cosmetic Act Dockets Management (HFA–305), Food and/or go to the Division of Dockets
(the FD&C Act). The draft guidance and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
describes FDA’s compliance policy for Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
cigars in packaging that is too small or • For written/paper comments Submit written requests for single
otherwise unable to accommodate a submitted to the Division of Dockets copies of this guidance to the Center for
label with sufficient space to bear the Management, FDA will post your Tobacco Products, Food and Drug
required warning statements. The draft comment, as well as any attachments, Administration, Document Control
guidance explains that FDA does not except for information submitted, Center, Bldg. 71, Rm. G335, 10903 New
intend to take enforcement action with marked and identified, as confidential, Hampshire Ave., Silver Spring, MD
respect to cigars that do not comply if submitted as detailed in 20993–0002. Send one self-addressed
with the size and placement ‘‘instructions.’’ adhesive label to assist that office in
requirements in the regulation when the Instructions: All submissions received processing your request or include a fax
sradovich on DSK3GMQ082PROD with NOTICES
information and specifications required must include the Docket No. FDA– number to which the guidance
under the regulation appear on the 2017–D–0121 for ‘‘Compliance Policy document may be sent. See the
carton or other outer container or for Required Warning Statements on SUPPLEMENTARY INFORMATION section for
wrapper that could accommodate the Small-Packaged Cigars.’’ Received information on electronic access to the
required warning statements, or on a tag comments will be placed in the docket guidance.
otherwise firmly and permanently and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
affixed to the cigar package. ‘‘Confidential Submissions,’’ publicly Deirdre Jurand, Center for Tobacco
VerDate Sep<11>2014 18:21 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/82_FR_4900/page/3.svg)
Document Created: 2017-01-14 01:44:48
Document Modified: 2017-01-14 01:44:48
| 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 March 20, 2017. | |
| Contact | Andrew LeBoeuf, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240- 402-0503, [email protected] | |
| FR Citation | 82 FR 4890 |
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