82 FR 19050 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 78 (April 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 78 (April 25, 2017)
| Page Range | 19050-19051 | |
| FR Document | 2017-08307 |
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)] [Notices] [Pages 19050-19051] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08307] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0008] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 May 25, 2017. 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 [email protected]. All comments should be identified with the OMB control number 0910-0679. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. 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. Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act--OMB Control Number 0910-0679--Extension FDA's guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' provides information regarding FDA's current thinking on interpreting section 914 of Title IX of the Food and Drug Administration Amendments Act (FDAAA) (Pub. L. 110-85). Section 914 of FDAAA added new section 505(q) to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(q)) and governs certain citizen petitions and petitions for stay of Agency action that request that FDA take any form of action related to a pending application submitted under section 505(b)(2) or 505(j) of the FD&C Act. The guidance describes FDA's interpretation of section 505(q) of the FD&C Act regarding how the Agency will determine if: (1) The provisions of section 505(q) addressing the treatment of citizen petitions and petitions for stay of Agency action (collectively, petitions) apply to a particular petition and (2) a petition would delay approval of a pending abbreviated new drug application (ANDA) or a 505(b)(2) application. The guidance also describes how FDA will interpret the provisions of section 505(q) requiring that: (1) A petition includes a certification and (2) supplemental information or comments to a petition include a verification. Finally, the guidance addresses the relationship between the review of petitions and pending ANDAs and 505(b)(2) applications for which the Agency has not yet made a decision on approvability. The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 (Pub. L. 112-144). Section 1135 of FDASIA amended section 505(q) of the FD&C Act in two ways. First, it shortened FDA's deadline from 180 days to 150 days for responding to petitions subject to section 505(q) of the FD&C Act. Second, it expanded the scope of section 505(q) of the FD&C Act to include certain petitions concerning applications submitted under section 351(k) of the Public Health Service Act (42 U.S.C. 262), the abbreviated pathway for the approval of biosimilar biological products. Accordingly, we are now including submissions pertaining to biosimilar biological product applications in the information collection burden estimates in this document. Section 505(q)(1)(H) of the FD&C Act requires that citizen petitions and petitions for stay of Agency action that are subject to section 505(q) include a certification to be considered for review by FDA. Section 505(q)(1)(I) of the FD&C Act requires that supplemental information or comments to such citizen petitions and petitions for stay of Agency action include a verification to be accepted for review by FDA. The guidance sets forth the criteria the Agency will use in determining if the provisions of section 505(q) of the FD&C Act apply to a particular citizen petition or petition for stay of Agency action. The guidance states that one of the criteria for a citizen petition or petition for stay of Agency action to be subject to section 505(q) of the FD&C Act is that a related ANDA or 505(b)(2) application is pending at the time the citizen petition or petition for stay is submitted. Because petitioners or commenters may not be aware of the existence of a pending ANDA or 505(b)(2) application, the guidance recommends that all petitioners challenging the approvability of a possible ANDA or 505(b)(2) application include the certification required in section 505(q)(1)(H) of the FD&C Act and that petitioners and commenters submitting supplements or comments, respectively, to a citizen petition or petition for stay of action challenging the approvability of a possible ANDA or 505(b)(2) application include the verification required in section 505(q)(1)(I) of the FD&C Act. The guidance also recommends that if a petitioner submits a citizen petition or petition for stay of Agency action that is missing the required certification but is otherwise within the scope of section 505(q) of the FD&C Act and the petitioner would like FDA to review the citizen petition or petition for stay of Agency action, the petitioner should submit a letter withdrawing the deficient petition and submit a new petition that contains the required certification. FDA currently has OMB approval for the collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' (OMB control number 0910-0191). This collection of information includes, among other things: (1) The format and procedures by which an interested person may submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20), a citizen petition requesting the Commissioner of Food and Drugs (Commissioner) to issue, amend, or revoke a regulation or order, [[Page 19051]] or to take or refrain from taking any other form of administrative action (Sec. 10.30(b) (21 CFR 10.30(b))); (2) the submission of written comments on a filed citizen petition (Sec. 10.30(d)); (3) the submission of a supplement or amendment to or a letter to withdraw a filed citizen petition (Sec. 10.30(g)); (4) the format and procedures by which an interested person may request, in accordance with Sec. 10.20, the Commissioner to stay the effective date of any administrative action (Sec. 10.35(b) (21 CFR 10.35(b))); and (5) the submission of written comments on a filed petition for administrative stay of action (Sec. 10.35(c)). This information collection includes citizen petitions, petitions for administrative stay of action, comments to petitions, supplements to citizen petitions, and letters to withdraw a citizen petition, as described previously in this document, which are subject to section 505(q) of the FD&C Act and described in the guidance. We are requesting OMB approval for the following collection of information submitted to FDA under section 505(q) of the FD&C Act and the guidance:The certification required under section 505(q)(1)(H) of the FD&C Act for citizen petitions that are subject to section 505(q) and/or that are challenging the approvability of a possible ANDA, 505(b)(2) application, or biosimilar biological product application. Although the submission of a certification for citizen petitions is approved under OMB control number 0910-0191, the certification would be broadened under section 505(q) of the FD&C Act and the guidance. The certification required under section 505(q)(1)(H) of the FD&C Act for petitions for stay of Agency action that are subject to section 505(q) and/or that are challenging the approvability of a possible ANDA, 505(b)(2) application, or biosimilar biological product application. The verification required under section 505(q)(1)(I) of the FD&C Act for comments to citizen petitions. The verification required under section 505(q)(1)(I) of the FD&C Act for comments to petitions for stay of Agency action. The verification required under section 505(q)(1)(I) of the FD&C Act for supplements to citizen petitions. Supplements to petitions for stay of Agency action. The verification required under section 505(q)(1)(I) of the FD&C Act for supplements to petitions for stay of Agency action. The letter submitted by a petitioner withdrawing a deficient petition for stay of Agency action that is missing the required certification but is otherwise within the scope of section 505(q) of the FD&C Act. Section 505(q)(1)(B) and (C) of the FD&C Act and the guidance state that if FDA determines that a delay in approval of an ANDA, 505(b)(2) application, or biosimilar biological product application is necessary based on a petition subject to section 505(q), the applicant may submit to the petition docket clarifications or additional data to allow FDA to review the petition promptly. While we have not included a burden estimate for this provision under the instant information collection, it is included under OMB control number 0910-0001 (21 CFR 314.54, 314.94, and 314.102). In the Federal Register of January 10, 2017 (82 FR 2999), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the notice. Therefore, based on our knowledge of citizen petitions and petitions for stay of Agency action subject to section 505(q) of the FD&C Act that have been submitted to FDA, as well as our familiarity with the time needed to prepare a supplement, a certification, and a verification, we estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/FD&C Act section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Certification for citizen 38 1.37 52 .5 (30 minutes). 26 petitions; 505(q)(1)(H). Certification for petitions 3 1 3 .5 (30 minutes). 1.5 for stay of Agency action; 505(q)(1)(H). Verification for comments to 12 1.66 20 .5 (30 minutes). 10 citizen petitions; 505(q)(1)(I). Verification for comments to 1 1 1 .5 (30 minutes). .5 petitions for stay of Agency action; 505(q)(1)(I). Verification for supplements 7 2.29 16 .5 (30 minutes). 8 to citizen petitions; 505(q)(1)(I). Supplements to petitions for 1 1 1 6............... 6 stay of Agency action. Verification for supplements 1 1 1 .5 (30 minutes). .5 to petitions for stay of Agency action; 505(q)(1)(I). Letter withdrawing a petition 3 1 3 .5 (30 minutes). 1.5 for stay of Agency action. --------------------------------------------------------------------------------- Total Hours............... .............. .............. .............. ................ 54 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-08307 Filed 4-24-17; 8:45 am] BILLING CODE 4164-01-P
![19050 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
Dated: April 19, 2017. Guidance for Industry on Citizen collection burden estimates in this
Anna K. Abram, Petitions and Petitions for Stay of document.
Deputy Commissioner for Policy, Planning, Action Subject to Section 505(q) of the Section 505(q)(1)(H) of the FD&C Act
Legislation, and Analysis. Federal Food, Drug, and Cosmetic requires that citizen petitions and
[FR Doc. 2017–08303 Filed 4–24–17; 8:45 am] Act—OMB Control Number 0910– petitions for stay of Agency action that
0679—Extension are subject to section 505(q) include a
BILLING CODE 4164–01–P
certification to be considered for review
FDA’s guidance for industry entitled by FDA. Section 505(q)(1)(I) of the
‘‘Citizen Petitions and Petitions for Stay FD&C Act requires that supplemental
DEPARTMENT OF HEALTH AND of Action Subject to Section 505(q) of information or comments to such citizen
HUMAN SERVICES the Federal Food, Drug, and Cosmetic petitions and petitions for stay of
Act’’ provides information regarding Agency action include a verification to
Food and Drug Administration
FDA’s current thinking on interpreting be accepted for review by FDA. The
section 914 of Title IX of the Food and guidance sets forth the criteria the
[Docket No. FDA–2009–D–0008] Drug Administration Amendments Act Agency will use in determining if the
(FDAAA) (Pub. L. 110–85). Section 914 provisions of section 505(q) of the FD&C
Agency Information Collection of FDAAA added new section 505(q) to Act apply to a particular citizen petition
Activities; Submission for Office of the Federal Food, Drug, and Cosmetic or petition for stay of Agency action.
Management and Budget Review; Act (the FD&C Act) (21 U.S.C. 355(q)) The guidance states that one of the
Comment Request; Citizen Petitions and governs certain citizen petitions criteria for a citizen petition or petition
and Petitions for Stay of Action and petitions for stay of Agency action for stay of Agency action to be subject
Subject to Section 505(q) of the that request that FDA take any form of to section 505(q) of the FD&C Act is that
Federal Food, Drug, and Cosmetic Act action related to a pending application a related ANDA or 505(b)(2) application
submitted under section 505(b)(2) or is pending at the time the citizen
AGENCY: Food and Drug Administration, 505(j) of the FD&C Act. The guidance petition or petition for stay is submitted.
HHS. describes FDA’s interpretation of Because petitioners or commenters may
section 505(q) of the FD&C Act not be aware of the existence of a
ACTION: Notice.
regarding how the Agency will pending ANDA or 505(b)(2) application,
determine if: (1) The provisions of the guidance recommends that all
SUMMARY: The Food and Drug petitioners challenging the
Administration (FDA or we) is section 505(q) addressing the treatment
of citizen petitions and petitions for stay approvability of a possible ANDA or
announcing that a proposed collection 505(b)(2) application include the
of Agency action (collectively, petitions)
of information has been submitted to the certification required in section
apply to a particular petition and (2) a
Office of Management and Budget petition would delay approval of a 505(q)(1)(H) of the FD&C Act and that
(OMB) for review and clearance under pending abbreviated new drug petitioners and commenters submitting
the Paperwork Reduction Act of 1995. application (ANDA) or a 505(b)(2) supplements or comments, respectively,
application. The guidance also describes to a citizen petition or petition for stay
DATES: Fax written comments on the
how FDA will interpret the provisions of action challenging the approvability
collection of information by May 25,
of section 505(q) requiring that: (1) A of a possible ANDA or 505(b)(2)
2017. application include the verification
petition includes a certification and (2)
ADDRESSES: To ensure that comments on supplemental information or comments required in section 505(q)(1)(I) of the
the information collection are received, to a petition include a verification. FD&C Act. The guidance also
OMB recommends that written Finally, the guidance addresses the recommends that if a petitioner submits
relationship between the review of a citizen petition or petition for stay of
comments be faxed to the Office of
petitions and pending ANDAs and Agency action that is missing the
Information and Regulatory Affairs,
505(b)(2) applications for which the required certification but is otherwise
OMB, Attn: FDA Desk Officer, FAX: within the scope of section 505(q) of the
202–395–7285, or emailed to oira_ Agency has not yet made a decision on
approvability. FD&C Act and the petitioner would like
submission@omb.eop.gov. All FDA to review the citizen petition or
comments should be identified with the The Food and Drug Administration petition for stay of Agency action, the
OMB control number 0910–0679. Also Safety and Innovation Act (FDASIA) petitioner should submit a letter
include the FDA docket number found was signed into law on July 9, 2012 withdrawing the deficient petition and
in brackets in the heading of this (Pub. L. 112–144). Section 1135 of submit a new petition that contains the
document. FDASIA amended section 505(q) of the required certification.
FD&C Act in two ways. First, it FDA currently has OMB approval for
FOR FURTHER INFORMATION CONTACT: shortened FDA’s deadline from 180 the collection of information entitled
JonnaLynn Capezzuto, Office of days to 150 days for responding to ‘‘General Administrative Procedures:
Operations, Food and Drug petitions subject to section 505(q) of the Citizen Petitions; Petition for
Administration, Three White Flint FD&C Act. Second, it expanded the Reconsideration or Stay of Action;
North, 10A63, 11601 Landsdown St., scope of section 505(q) of the FD&C Act Advisory Opinions’’ (OMB control
North Bethesda, MD 20852, 301–796– to include certain petitions concerning number 0910–0191). This collection of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
3794. applications submitted under section information includes, among other
351(k) of the Public Health Service Act things: (1) The format and procedures
SUPPLEMENTARY INFORMATION: In (42 U.S.C. 262), the abbreviated by which an interested person may
compliance with 44 U.S.C. 3507, FDA pathway for the approval of biosimilar submit to FDA, in accordance with
has submitted the following proposed biological products. Accordingly, we are § 10.20 (21 CFR 10.20), a citizen petition
collection of information to OMB for now including submissions pertaining requesting the Commissioner of Food
review and clearance. to biosimilar biological product and Drugs (Commissioner) to issue,
applications in the information amend, or revoke a regulation or order,
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![Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19051
or to take or refrain from taking any possible ANDA, 505(b)(2) application, required certification but is otherwise
other form of administrative action or biosimilar biological product within the scope of section 505(q) of the
(§ 10.30(b) (21 CFR 10.30(b))); (2) the application. Although the submission of FD&C Act.
submission of written comments on a a certification for citizen petitions is Section 505(q)(1)(B) and (C) of the
filed citizen petition (§ 10.30(d)); (3) the approved under OMB control number FD&C Act and the guidance state that if
submission of a supplement or 0910–0191, the certification would be FDA determines that a delay in approval
amendment to or a letter to withdraw a broadened under section 505(q) of the of an ANDA, 505(b)(2) application, or
filed citizen petition (§ 10.30(g)); (4) the FD&C Act and the guidance. biosimilar biological product
format and procedures by which an • The certification required under application is necessary based on a
interested person may request, in section 505(q)(1)(H) of the FD&C Act for petition subject to section 505(q), the
accordance with § 10.20, the petitions for stay of Agency action that applicant may submit to the petition
Commissioner to stay the effective date are subject to section 505(q) and/or that docket clarifications or additional data
of any administrative action (§ 10.35(b) are challenging the approvability of a to allow FDA to review the petition
(21 CFR 10.35(b))); and (5) the possible ANDA, 505(b)(2) application, promptly. While we have not included
submission of written comments on a or biosimilar biological product a burden estimate for this provision
filed petition for administrative stay of application. under the instant information
action (§ 10.35(c)). This information • The verification required under collection, it is included under OMB
collection includes citizen petitions, section 505(q)(1)(I) of the FD&C Act for control number 0910–0001 (21 CFR
petitions for administrative stay of comments to citizen petitions. 314.54, 314.94, and 314.102).
action, comments to petitions, • The verification required under In the Federal Register of January 10,
supplements to citizen petitions, and section 505(q)(1)(I) of the FD&C Act for 2017 (82 FR 2999), we published a 60-
letters to withdraw a citizen petition, as comments to petitions for stay of day notice requesting public comment
described previously in this document, Agency action. on the proposed extension of this
which are subject to section 505(q) of • The verification required under collection of information. No comments
the FD&C Act and described in the section 505(q)(1)(I) of the FD&C Act for were received in response to the notice.
guidance. supplements to citizen petitions. Therefore, based on our knowledge of
We are requesting OMB approval for • Supplements to petitions for stay of citizen petitions and petitions for stay of
the following collection of information Agency action. Agency action subject to section 505(q)
submitted to FDA under section 505(q) • The verification required under of the FD&C Act that have been
of the FD&C Act and the guidance: section 505(q)(1)(I) of the FD&C Act for submitted to FDA, as well as our
• The certification required under supplements to petitions for stay of familiarity with the time needed to
section 505(q)(1)(H) of the FD&C Act for Agency action. prepare a supplement, a certification,
citizen petitions that are subject to • The letter submitted by a petitioner and a verification, we estimate the
section 505(q) and/or that are withdrawing a deficient petition for stay burden of this collection of information
challenging the approvability of a of Agency action that is missing the as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/FD&C Act section responses per burden per Total hours
respondents responses
respondent response
Certification for citizen petitions; 505(q)(1)(H) ..... 38 1.37 52 .5 (30 minutes) .............. 26
Certification for petitions for stay of Agency ac- 3 1 3 .5 (30 minutes) .............. 1.5
tion; 505(q)(1)(H).
Verification for comments to citizen petitions; 12 1.66 20 .5 (30 minutes) .............. 10
505(q)(1)(I).
Verification for comments to petitions for stay of 1 1 1 .5 (30 minutes) .............. .5
Agency action; 505(q)(1)(I).
Verification for supplements to citizen petitions; 7 2.29 16 .5 (30 minutes) .............. 8
505(q)(1)(I).
Supplements to petitions for stay of Agency ac- 1 1 1 6 .................................... 6
tion.
Verification for supplements to petitions for stay 1 1 1 .5 (30 minutes) .............. .5
of Agency action; 505(q)(1)(I).
Letter withdrawing a petition for stay of Agency 3 1 3 .5 (30 minutes) .............. 1.5
action.
Total Hours ................................................... ........................ ........................ ........................ ....................................... 54
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08307 Filed 4–24–17; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2017-04-25 02:18:29
Document Modified: 2017-04-25 02:18:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 25, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 19050 |
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