81 FR 59633 - Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 168 (August 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 168 (August 30, 2016)
| Page Range | 59633-59634 | |
| FR Document | 2016-20778 |
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)] [Notices] [Pages 59633-59634] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20778] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic risperidone injection, entitled ``Bioequivalence Recommendations for Risperidone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 31, 2016. 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. [[Page 59634]] If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2007-D-0369 for ``Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' will be 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: Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for generic risperidone injection. FDA initially approved new drug application 021346 for RISPERDAL CONSTA (risperidone) LONG-ACTING INJECTION in October 2003. Currently, there are no approved ANDAs for this product. In February 2010, FDA issued a draft guidance for industry on BE recommendations for generic risperidone injection. In August 2013 and May 2015, we issued revised draft guidances on the same subject. We are now issuing another revision of the draft guidance for industry on BE recommendations for generic risperidone injection (Draft Guidance on Risperidone). In February 2011, Johnson & Johnson Pharmaceutical Research and Development, LLC, manufacturer of RISPERDAL CONSTA LONG-ACTING INJECTION, the reference listed drug, submitted a citizen petition requesting that FDA require that any ANDA referencing RISPERDAL CONSTA LONG-ACTING INJECTION meet certain requirements, including requirements related to demonstrating BE (Docket No. FDA-2011-P-0086). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the revised draft BE recommendations in responding to the petition. 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 the design of BE studies to support ANDAs for risperidone injection. It does not establish any rights for any person 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: August 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20778 Filed 8-29-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 59633
DEPARTMENT OF HEALTH AND from States and Territories for the promote abstinence from sexual activity,
HUMAN SERVICES development and implementation of the with a focus on those groups which are
State Abstinence Program. The purpose most likely to bear children out-of-
Administration for Children and of this program is to support decisions wedlock. An expected outcome for all
Families to abstain from sexual activity by programs is to promote abstinence from
providing abstinence programming as sexual activity.
Proposed Information Collection defined by Section 510(b) of the Social OMB approval is requested to solicit
Activity, Comment Request Security Act (42 U.S.C. 710(b)) with a comments from the public on
Proposed Project focus on those groups that are most paperwork reduction as it relates to
likely to bear children out-of-wedlock, ACYF’s receipt of the following
Title: State Abstinence Education such as youth in or aging out of foster documents from applicants and
Program. care and other vulnerable populations. awardees:
OMB No.: 0970–0381. States are encouraged to develop State Plan.
Description: Section 215 of the flexible, medically accurate and Performance Progress Report.
Medicare Access and CHIP effective abstinence-based plans Respondents: 50 States and 9
Reauthorization Act of 2015 (Pub. L. responsive to their specific needs and Territories, to include, District of
114–10) 42 U.S.C. 1305 extended inclusive of vulnerable populations. Columbia, Puerto Rico, Virgin Islands,
funding through FY 2017 for the State These plans must provide abstinence Guam, American Samoa, Northern
Abstinence Program. education, and at the option of the State, Mariana Islands, the Federated States of
The Family and Youth Services where appropriate, mentoring, Micronesia, the Marshall Islands and
Bureau (FYSB) is accepting applications counseling, and adult supervision to Palau.
ANNUAL BURDEN ESTIMATES
Average
Number of
Number of burden Total burden
Instrument responses per
respondents hours per hours
respondent response
State Plan ........................................................................................................ 59 1 40 2,360
Performance Progress Reports ....................................................................... 59 2 30 3,540
Estimated Total Annual Burden use of automated collection techniques DATES: Although you can comment on
Hours: 5,900. or other forms of information any guidance at any time (see 21 CFR
In compliance with the requirements technology. Consideration will be given 10.115(g)(5)), to ensure that the Agency
of section 506(c)(2)(A) of the Paperwork to comments and suggestions submitted considers your comment on this draft
Reduction Act of 1995, the within 60 days of this publication. guidance before it begins work on the
Administration for Children and final version of the guidance, submit
Robert Sargis,
Families is soliciting public comment either electronic or written comments
Reports Clearance Officer. on the draft guidance by October 31,
on the specific aspects of the
[FR Doc. 2016–20729 Filed 8–29–16; 8:45 am] 2016.
information collection described above.
Copies of the proposed collection of BILLING CODE P
ADDRESSES: You may submit comments
information can be obtained and as follows:
comments may be forwarded by writing
DEPARTMENT OF HEALTH AND Electronic Submissions
to the Administration for Children and
HUMAN SERVICES
Families, Office of Planning, Research Submit electronic comments in the
and Evaluation, 370 l’Enfant Food and Drug Administration following way:
Promenade, SW., Washington, DC • Federal eRulemaking Portal: http://
20447, Attn: Reports Clearance Officer, [Docket No. FDA–2007–D–0369] www.regulations.gov. Follow the
email address: infocollection@ instructions for submitting comments.
acf.hhs.gov. All request should be Bioequivalence Recommendations for
Comments submitted electronically,
identified by the title of the information Risperidone; Draft Guidance for
including attachments, to http://
collection. Industry; Availability
www.regulations.gov will be posted to
The Department specifically request AGENCY: Food and Drug Administration, the docket unchanged. Because your
comments on: (a) Whether the proposed HHS. comment will be made public, you are
collection of information is necessary ACTION: Notice of availability. solely responsible for ensuring that your
for the proper performance of the comment does not include any
functions of the agency, including SUMMARY: The Food and Drug confidential information that you or a
whether the information shall have Administration (FDA) is announcing the third party may not wish to be posted,
practical utility: (b) the accuracy of the availability of a revised draft guidance such as medical information, your or
agencies estimate of the burden of the for industry on generic risperidone anyone else’s Social Security number, or
mstockstill on DSK3G9T082PROD with NOTICES
proposed collection of information; (c) injection, entitled ‘‘Bioequivalence confidential business information, such
the quality, utility, and clarity of the Recommendations for Risperidone.’’ as a manufacturing process. Please note
information to be collected; (d) ways to The recommendations provide specific that if you include your name, contact
minimize the burden information to be guidance on the design of information, or other information that
collected; and (e) ways to minimize the bioequivalence (BE) studies to support identifies you in the body of your
burden of the collection of information abbreviated new drug applications comments, that information will be
on respondents, including through the (ANDAs) for risperidone injection. posted on http://www.regulations.gov.
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![59634 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
• If you want to submit a comment 56469, September 18, 2015, or access and May 2015, we issued revised draft
with confidential information that you the information at: http://www.fda.gov/ guidances on the same subject. We are
do not wish to be made available to the regulatoryinformation/dockets/default. now issuing another revision of the draft
public, submit the comment as a htm. guidance for industry on BE
written/paper submission and in the Docket: For access to the docket to recommendations for generic
manner detailed (see ‘‘Written/Paper read background documents or the risperidone injection (Draft Guidance on
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Risperidone).
received, go to http:// In February 2011, Johnson & Johnson
Written/Paper Submissions Pharmaceutical Research and
www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the Development, LLC, manufacturer of
follows: heading of this document, into the RISPERDAL CONSTA LONG-ACTING
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts INJECTION, the reference listed drug,
written/paper submissions): Division of and/or go to the Division of Dockets submitted a citizen petition requesting
Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm. that FDA require that any ANDA
and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852. referencing RISPERDAL CONSTA
Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single LONG-ACTING INJECTION meet certain
• For written/paper comments copies of the draft guidance to the requirements, including requirements
submitted to the Division of Dockets Division of Drug Information, Center for related to demonstrating BE (Docket No.
Management, FDA will post your Drug Evaluation and Research, Food FDA–2011–P–0086). FDA is reviewing
comment, as well as any attachments, the issues raised in the petition. FDA
and Drug Administration, 10001 New
except for information submitted, will consider any comments on the
Hampshire Ave., Hillandale Building,
marked and identified, as confidential, revised draft BE recommendations in
4th Floor, Silver Spring, MD 20993–
if submitted as detailed in responding to the petition.
0002. Send one self-addressed adhesive
‘‘Instructions.’’ This draft guidance is being issued
Instructions: All submissions received label to assist that office in processing
your requests. See the SUPPLEMENTARY consistent with FDA’s good guidance
must include the Docket No. FDA– practices regulation (21 CFR 10.115).
INFORMATION section for electronic
2007–D–0369 for ‘‘Bioequivalence The draft guidance, when finalized, will
Recommendations for Risperidone; access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
represent the current thinking of FDA
Draft Guidance for Industry.’’ Received on the design of BE studies to support
comments will be placed in the docket Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600), ANDAs for risperidone injection. It does
and, except for those submitted as not establish any rights for any person
‘‘Confidential Submissions,’’ will be Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. is not binding on FDA or the public.
publicly viewable at http:// You can use an alternative approach if
www.regulations.gov or at the Division 4730, Silver Spring, MD 20993–0002,
301–796–5850. it satisfies the requirements of the
of Dockets Management between 9 a.m. applicable statutes and regulations.
and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION:
• Confidential Submissions—To II. Electronic Access
submit a comment with confidential I. Background
Persons with access to the Internet
information that you do not wish to be In the Federal Register of June 11, may obtain the draft guidance at either
made publicly available, submit your 2010 (75 FR 33311), FDA announced the http://www.fda.gov/Drugs/
comments only as a written/paper availability of a guidance for industry GuidanceCompliance
submission. You should submit two entitled ‘‘Bioequivalence RegulatoryInformation/Guidances/
copies total. One copy will include the Recommendations for Specific default.htm or http://
information you claim to be confidential Products,’’ which explained the process www.regulations.gov.
with a heading or cover note that states that would be used to make product-
Dated: August 25, 2016.
‘‘THIS DOCUMENT CONTAINS specific BE recommendations available
CONFIDENTIAL INFORMATION.’’ The to the public on FDA’s Web site at Leslie Kux,
Agency will review this copy, including http://www.fda.gov/Drugs/ Associate Commissioner for Policy.
the claimed confidential information, in GuidanceCompliance [FR Doc. 2016–20778 Filed 8–29–16; 8:45 am]
its consideration of comments. The RegulatoryInformation/Guidances/ BILLING CODE 4164–01–P
second copy, which will have the default.htm. As described in that
claimed confidential information guidance, FDA adopted this process to
redacted/blacked out, will be available develop and disseminate product- DEPARTMENT OF HEALTH AND
for public viewing and posted on http:// specific BE recommendations and to HUMAN SERVICES
www.regulations.gov. Submit both provide a meaningful opportunity for
Food and Drug Administration
copies to the Division of Dockets the public to consider and comment on
Management. If you do not wish your those recommendations. This notice [Docket No. FDA–2016–N–0001]
name and contact information to be announces the availability of draft BE
made publicly available, you can recommendations for generic Vaccines and Related Biological
provide this information on the cover risperidone injection. Products Advisory Committee; Notice
sheet and not in the body of your FDA initially approved new drug of Meeting
comments and you must identify this application 021346 for RISPERDAL
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration,
information as ‘‘confidential.’’ Any CONSTA (risperidone) LONG-ACTING HHS.
information marked as ‘‘confidential’’ INJECTION in October 2003. Currently, ACTION: Notice.
will not be disclosed except in there are no approved ANDAs for this
accordance with 21 CFR 10.20 and other product. In February 2010, FDA issued SUMMARY: The Food and Drug
applicable disclosure law. For more a draft guidance for industry on BE Administration (FDA) announces a
information about FDA’s posting of recommendations for generic forthcoming public advisory committee
comments to public dockets, see 80 FR risperidone injection. In August 2013 meeting of the Vaccines and Related
VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1](https://thefederalregister.org/doc/81_FR_59801/page/2.svg)
Document Created: 2018-02-09 11:42:05
Document Modified: 2018-02-09 11:42:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 31, 2016. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850. | |
| FR Citation | 81 FR 59633 |
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