83 FR 4216 - Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 20 (January 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 20 (January 30, 2018)
| Page Range | 4216-4218 | |
| FR Document | 2018-01662 |
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)] [Notices] [Pages 4216-4218] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01662] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-7001] Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualified Infectious Disease Product Designation Questions and Answers.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this draft guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product (QIDP). DATES: Submit either electronic or written comments on the draft guidance by April 2, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: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-2017-D-7001 for ``Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry.'' 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 [[Page 4217]] 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.thefederalregister.org/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: Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301- 796-1182. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Qualified Infectious Disease Product Designation Questions and Answers.'' Title VIII of FDASIA created the Generating Antibiotic Incentives Now (GAIN) provisions under section 505E of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355f). GAIN offers incentives for the development of antibacterial and antifungal drugs for human use to treat serious or life-threatening infections. The primary incentive contained in GAIN is a 5-year extension of exclusivity for which a QIDP-designated application qualifies upon approval under the FD&C Act. QIDPs also receive fast track designation at the sponsor's request (21 U.S.C. 356(b)(1)) and the first marketing application submitted for approval of a QIDP is granted priority review (21 U.S.C. 360n-1). This draft guidance provides information on the implementation of GAIN and responses to common questions that might arise regarding QIDP designation and review of QIDP new drug applications. 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 qualified infectious disease product designation questions and answers. 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 Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (PRA), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Draft Guidance for Industry on Qualified Infectious Disease Product Designation Questions and Answers. Description: As described in the draft guidance, a sponsor may request a QIDP designation at any time prior to that sponsor's submission of a marketing application under section 505(b) of the FD&C Act (21 U.S.C. 355(b)) for that sponsor's drug product. A request for QIDP designation should be submitted either to an investigational new drug (IND) application or as pre-IND correspondence. The cover letter for the QIDP designation request should include the following text in bold font at the top of the page: ``Request for Qualified Infectious Disease Product Designation Questions and Answers.'' Requests for multiple indications can be combined in a single submission or made separately. The sponsor should clearly identify each indication for which it is requesting QIDP designation. As described further in the draft guidance, each request should include: (1) A discussion of the information that supports the role of the drug as an antibacterial or antifungal drug, for example, in vitro data, including any available data on mechanism of action; data from animal models of infection; (2) any available human data from phase 1, phase 2, or phase 3 studies; (3) the specific serious or life- threatening indication(s) for which the sponsor intends (or has begun) to develop the drug and the rationale or suitability for developing the drug for the proposed serious or life-threatening infection(s); and (4) the request may (but is not required to) include information to demonstrate that the product is an antibacterial or antifungal drug that has the capacity to treat a serious or life-threatening infection caused by either of the following: resistant pathogen(s), including novel or emerging infectious pathogens, and qualifying pathogens listed in 21 CFR 317.2. We estimate that approximately 33 requests for QIDP designation, as described in the draft guidance, will be submitted annually by approximately 25 sponsors, and that it will take approximately 60 hours to prepare and submit each request. FDA estimates the burden of this collection of information as follows: [[Page 4218]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Hours per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- Requests for a QIDP Designation.................................... 25 1.32 33 60 1,980 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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: January 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01662 Filed 1-29-18; 8:45 am] BILLING CODE 4164-01-P
![4216 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
was August 8, 2011, which was the date Dated: January 24, 2018. identifies you in the body of your
a major health or environmental effects Leslie Kux, comments, that information will be
test was begun. Associate Commissioner for Policy. posted on https://www.regulations.gov.
[FR Doc. 2018–01640 Filed 1–29–18; 8:45 am] • If you want to submit a comment
2. The date the application was
with confidential information that you
initially submitted with respect to the BILLING CODE 4164–01–P
do not wish to be made available to the
animal drug product under section 512 public, submit the comment as a
of the FD&C Act (21 U.S.C. 360b): written/paper submission and in the
DEPARTMENT OF HEALTH AND
January 29, 2016. The applicant claims manner detailed (see ‘‘Written/Paper
HUMAN SERVICES
January 25, 2016, as the date the new Submissions’’ and ‘‘Instructions’’).
animal drug application (NADA) for Food and Drug Administration
GALLIPRANT (NADA 141–455) was Written/Paper Submissions
[Docket No. FDA–2017–D–7001] Submit written/paper submissions as
initially submitted. However, FDA
records indicate that NADA 141–455 Qualified Infectious Disease Product follows:
was submitted on January 29, 2016. • Mail/Hand delivery/Courier (for
Designation Questions and Answers;
written/paper submissions): Dockets
3. The date the application was Draft Guidance for Industry;
Management Staff (HFA–305), Food and
approved: March 20, 2016. The Availability
Drug Administration, 5630 Fishers
applicant claims that NADA 141–455 AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
was approved on March 21, 2016, HHS. • For written/paper comments
however, FDA records indicate that ACTION: Notice of availability. submitted to the Dockets Management
NADA 141–455 was approved on Staff, FDA will post your comment, as
Sunday, March 20, 2016. SUMMARY: The Food and Drug well as any attachments, except for
This determination of the regulatory Administration (FDA or Agency) is information submitted, marked and
announcing the availability of a draft identified, as confidential, if submitted
review period establishes the maximum
guidance for industry entitled as detailed in ‘‘Instructions.’’
potential length of a patent extension.
‘‘Qualified Infectious Disease Product Instructions: All submissions received
However, the USPTO applies several Designation Questions and Answers.’’ must include the Docket No. FDA–
statutory limitations in its calculations The Food and Drug Administration 2017–D–7001 for ‘‘Qualified Infectious
of the actual period for patent extension. Safety and Innovation Act (FDASIA) Disease Product Designation Questions
In its application for patent extension, creates incentives for the development and Answers; Draft Guidance for
this applicant seeks 899 days of patent of antibacterial and antifungal drug Industry.’’ Received comments will be
term extension. products that treat serious or life- placed in the docket and, except for
III. Petitions threatening infections. The purpose of those submitted as ‘‘Confidential
this draft guidance is to provide a Submissions,’’ publicly viewable at
Anyone with knowledge that any of resource for information on FDA’s https://www.regulations.gov or at the
the dates as published are incorrect may policies and procedures related to the Dockets Management Staff between 9
submit either electronic or written designation of a qualified infectious a.m. and 4 p.m., Monday through
comments and, under 21 CFR 60.24, ask disease product (QIDP). Friday.
for a redetermination (see DATES). DATES: Submit either electronic or • Confidential Submissions—To
Furthermore, as specified in § 60.30 (21 written comments on the draft guidance submit a comment with confidential
CFR 60.30), any interested person may by April 2, 2018 to ensure that the information that you do not wish to be
petition FDA for a determination Agency considers your comment on this made publicly available, submit your
regarding whether the applicant for draft guidance before it begins work on comments only as a written/paper
the final version of the guidance. submission. You should submit two
extension acted with due diligence
ADDRESSES: You may submit comments copies total. One copy will include the
during the regulatory review period. To
on any guidance at any time as follows: information you claim to be confidential
meet its burden, the petition must
with a heading or cover note that states
comply with all the requirements of Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
§ 60.30, including but not limited to: CONFIDENTIAL INFORMATION.’’ The
Submit electronic comments in the
Must be timely (see DATES), must be following way: Agency will review this copy, including
filed in accordance with § 10.20, must • Federal eRulemaking Portal: the claimed confidential information, in
contain sufficient facts to merit an FDA https://www.regulations.gov. Follow the its consideration of comments. The
investigation, and must certify that a instructions for submitting comments. second copy, which will have the
true and complete copy of the petition Comments submitted electronically, claimed confidential information
has been served upon the patent including attachments, to https:// redacted/blacked out, will be available
applicant. (See H. Rept. 857, part 1, 98th www.regulations.gov will be posted to for public viewing and posted on
Cong., 2d sess., pp. 41–42, 1984.) the docket unchanged. Because your https://www.regulations.gov. Submit
Petitions should be in the format comment will be made public, you are both copies to the Dockets Management
specified in 21 CFR 10.30. solely responsible for ensuring that your Staff. If you do not wish your name and
Submit petitions electronically to comment does not include any contact information to be made publicly
https://www.regulations.gov at Docket confidential information that you or a available, you can provide this
daltland on DSKBBV9HB2PROD with NOTICES
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
petitions (two copies are required) to the
anyone else’s Social Security number, or must identify this information as
Dockets Management Staff (HFA–305),
confidential business information, such ‘‘confidential.’’ Any information marked
Food and Drug Administration, 5630 as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note
Fishers Lane, Rm. 1061, Rockville, MD that if you include your name, contact except in accordance with 21 CFR 10.20
20852. information, or other information that and other applicable disclosure law. For
VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1](https://thefederalregister.org/doc/83_FR_4236/page/1.svg)
![4218 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
Activity responses per Total hours
respondents responses response
respondent
Requests for a QIDP Designation ....................................... 25 1.32 33 60 1,980
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access considered. Electronic comments must identified, as confidential, if submitted
Persons with access to the internet be submitted on or before April 2, 2018. as detailed in ‘‘Instructions.’’
may obtain the draft guidance at either The https://www.regulations.gov Instructions: All submissions received
https://www.fda.gov/Drugs/Guidance electronic filing system will accept must include the Docket No. FDA–
ComplianceRegulatoryInformation/ comments until midnight Eastern Time 2016–E–0482 for ‘‘Determination of
Guidances/default.htm or https:// at the end of April 2, 2018. Comments Regulatory Review Period for Purposes
received by mail/hand delivery/courier of Patent Extension; VIEKIRA PAK.’’
www.regulations.gov.
(for written/paper submissions) will be Received comments, those filed in a
Dated: January 24, 2018. considered timely if they are timely manner (see ADDRESSES), will be
Leslie Kux, postmarked or the delivery service placed in the docket and, except for
Associate Commissioner for Policy. acceptance receipt is on or before that those submitted as ‘‘Confidential
[FR Doc. 2018–01662 Filed 1–29–18; 8:45 am] date. Submissions,’’ publicly viewable at
BILLING CODE 4164–01–P https://www.regulations.gov or at the
Electronic Submissions Dockets Management Staff between 9
Submit electronic comments in the a.m. and 4 p.m., Monday through
DEPARTMENT OF HEALTH AND following way: Friday.
HUMAN SERVICES • Confidential Submissions—To
• Federal eRulemaking Portal:
submit a comment with confidential
https://www.regulations.gov. Follow the
Food and Drug Administration information that you do not wish to be
instructions for submitting comments.
[Docket No. FDA–2016–E–0482] made publicly available, submit your
Comments submitted electronically,
comments only as a written/paper
including attachments, to https://
Determination of Regulatory Review submission. You should submit two
www.regulations.gov will be posted to
Period for Purposes of Patent copies total. One copy will include the
the docket unchanged. Because your
Extension; VIEKIRA PAK information you claim to be confidential
comment will be made public, you are
with a heading or cover note that states
AGENCY: Food and Drug Administration, solely responsible for ensuring that your
‘‘THIS DOCUMENT CONTAINS
HHS. comment does not include any
CONFIDENTIAL INFORMATION.’’ The
ACTION: Notice. confidential information that you or a
Agency will review this copy, including
third party may not wish to be posted,
the claimed confidential information, in
SUMMARY: The Food and Drug such as medical information, your or
its consideration of comments. The
Administration (FDA or the Agency) has anyone else’s Social Security number, or
second copy, which will have the
determined the regulatory review period confidential business information, such
claimed confidential information
for VIEKIRA PAK and is publishing this as a manufacturing process. Please note
redacted/blacked out, will be available
notice of that determination as required that if you include your name, contact
for public viewing and posted on
by law. FDA has made the information, or other information that
https://www.regulations.gov. Submit
determination because of the identifies you in the body of your
both copies to the Dockets Management
submission of an application to the comments, that information will be
Staff. If you do not wish your name and
Director of the U.S. Patent and posted on https://www.regulations.gov.
contact information to be made publicly
Trademark Office (USPTO), Department • If you want to submit a comment available, you can provide this
of Commerce, for the extension of a with confidential information that you information on the cover sheet and not
patent which claims that human drug do not wish to be made available to the in the body of your comments and you
product. public, submit the comment as a must identify this information as
DATES: Anyone with knowledge that any written/paper submission and in the ‘‘confidential.’’ Any information marked
of the dates as published (in the manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed
SUPPLEMENTARY INFORMATION section) are Submissions’’ and ‘‘Instructions’’). except in accordance with § 10.20 (21
incorrect may submit either electronic Written/Paper Submissions CFR 10.20) and other applicable
or written comments and ask for a disclosure law. For more information
redetermination by April 2, 2018. Submit written/paper submissions as about FDA’s posting of comments to
Furthermore, any interested person may follows: public dockets, see 80 FR 56469,
petition FDA for a determination • Mail/Hand delivery/Courier (for September 18, 2015, or access the
regarding whether the applicant for written/paper submissions): Dockets information at: https://www.gpo.gov/
extension acted with due diligence Management Staff (HFA–305), Food and fdsys/pkg/FR-2015-09-18/pdf/2015-
daltland on DSKBBV9HB2PROD with NOTICES
during the regulatory review period by Drug Administration, 5630 Fishers 23389.pdf.
July 30, 2018. See ‘‘Petitions’’ in the Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to
SUPPLEMENTARY INFORMATION section for • For written/paper comments read background documents or the
more information. submitted to the Dockets Management electronic and written/paper comments
ADDRESSES: You may submit comments Staff, FDA will post your comment, as received, go to https://
as follows. Please note that late, well as any attachments, except for www.regulations.gov and insert the
untimely filed comments will not be information submitted, marked and docket number, found in brackets in the
VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1](https://thefederalregister.org/doc/83_FR_4236/page/3.svg)
Document Created: 2018-10-26 10:10:45
Document Modified: 2018-10-26 10:10:45
| 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 | Submit either electronic or written comments on the draft guidance by April 2, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301- 796-1182. | |
| FR Citation | 83 FR 4216 |
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