80 FR 72069 - Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 222 (November 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 222 (November 18, 2015)
| Page Range | 72069-72071 | |
| FR Document | 2015-29455 |
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)] [Notices] [Pages 72069-72071] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29455] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0286] Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; 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 guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting packages to FDA for biosimilar biological products. This guidance finalizes the draft guidance issued on April 1, 2013. DATES: Submit either electronic or written comments on Agency guidances at any time. 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 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, [[Page 72070]] marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. [FDA-2013-D-0286] for Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability. 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 this 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 or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6483, Silver Spring, MD 20993-0002, 301-796-0970; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by CDER and CBER. For the purposes of this guidance, ``formal meeting'' includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference). The Biologics Price Competition and Innovation Act of 2009 amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act (42 U.S.C. 262(k)) for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub. L. 111-148)). The Biosimilar User Fee Act of 2012 (BsUFA), enacted as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize a new user fee program for biosimilar biological products. FDA has committed to meeting certain performance goals in connection with the new user fee program. The performance goals, which are set forth in a letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives,\1\ include meeting management goals for formal meetings that occur between FDA and sponsors or applicants during the development phase of a biosimilar biological product. This guidance describes the Agency's current thinking on how it intends to interpret and apply certain provisions of BsUFA, and also provides information on specific performance goals for the management of meetings associated with the development and review of biosimilar biological products. --------------------------------------------------------------------------- \1\ See http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf. --------------------------------------------------------------------------- This guidance reflects a unified approach to all formal meetings between sponsors or applicants and FDA for biosimilar biological product development (BPD) programs. It is intended to assist sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products. This guidance does not apply to new drug or abbreviated new drug applications under section 505 of the FD&C Act or to biologics license applications under section 351(a) of the PHS Act. FDA expects that review staff will participate in many meetings with biosimilar biological product sponsors or applicants who seek guidance relating to the development and review of biosimilar biological products. Because these meetings often will represent critical points in the regulatory process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings. The good meeting management practices in this guidance are intended to provide consistent procedures that will promote well-managed meetings and to ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately. The following five meeting types that occur between sponsors or applicants and FDA staff during the biosimilar BPD phase are described in the guidance: (1) Biosimilar Initial Advisory meeting; (2) BPD Type 1 meeting; (3) BPD Type 2 meeting; (4) BPD Type 3 meeting; and (5) BPD Type 4 meeting. [[Page 72071]] On April 1, 2013 (78 FR 19492), FDA announced the availability of a draft version of this guidance. All comments received during the comment period for the draft guidance have been reviewed and, where appropriate, incorporated into this guidance. As a result of the public comments, information has been added to provide clarity on the process for requesting meetings, including identifying the appropriate meeting type, and the data expectations to support the appropriate meeting type. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on formal meetings between FDA and biosimilar biological product sponsors or applicants. 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. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0802. III. Electronic Access Persons with access to the Internet may obtain the guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: November 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29455 Filed 11-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72069
qualified tropical disease may be about section 524, we estimate that we indicating the transfer of a voucher from
eligible for a voucher that can be used will receive annually approximately five two application holders, and two letters
to obtain a priority review for any requests from five sponsors, and that from two new voucher owners
application submitted under section each request will take approximately 8 acknowledging the transfer, and that it
505(b)(1) of the FD&C Act (21 U.S.C. hours to prepare and submit to FDA. will take approximately 8 hours to
355(b)(1)) or section 351 of the Public The guidance also states that sponsors prepare and submit each letter to FDA.
Health Service Act (the PHS Act). The should notify FDA of their intent to use In the Federal Register of October 20,
guidance explains to internal and a priority review voucher, including the 2008 (73 FR 62298), FDA published a
external stakeholders how FDA intends date on which the sponsor intends to 60-day notice requesting public
to implement the provisions of section submit the application, at least 90 days comment on the proposed collection of
524, and provides information on using before use. We estimate that we will information. The comments we received
the priority review vouchers and on receive annually approximately five did not pertain to the information
transferring priority review vouchers to notifications of intent to use a voucher collection that would result from the
from five sponsors, and that each guidance (that is, the four types of
other sponsors.
notification will take approximately 8 submissions estimated in table 1).
Under the guidance, sponsors of hours to prepare and submit to FDA.
certain tropical disease drug product The guidance also permits the transfer FDA estimates the burden of this
applications submitted under section of a priority review voucher from one collection of information as follows:
505(b)(1) of the FD&C Act and section sponsor to another, and states that each Description of Respondents: Sponsors
351 of the PHS Act may request a transfer should be documented with a submitting applications under section
priority review voucher. Based on letter of transfer. We estimate that we 505(b)(1) of the FD&C Act or section 351
inquiries and discussions with industry will receive approximately two letters of the PHS Act.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Guidance for Industry on Tropical Disease Priority Review Number of Total annual
responses per burden per Total hours
Vouchers respondents responses
respondent response
Priority Review Voucher Request ........................................ 5 1 5 8 40
Notifications of Intent To Use a Voucher ............................ 5 1 5 8 40
Letters Indicating the Transfer of a Voucher Letter ............ 2 1 2 8 16
Acknowledging the Receipt of a Transferred Voucher ........ 2 1 2 8 16
Total .............................................................................. ........................ ........................ ........................ ........................ 112
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 12, 2015. applicants relating to the development confidential information that you or a
Leslie Kux, and review of biosimilar biological third party may not wish to be posted,
Associate Commissioner for Policy. products regulated by the Center for such as medical information, your or
[FR Doc. 2015–29406 Filed 11–17–15; 8:45 am] Drug Evaluation and Research (CDER) anyone else’s Social Security number, or
BILLING CODE 4164–01–P
and the Center for Biologics Evaluation confidential business information, such
and Research (CBER). The guidance as a manufacturing process. Please note
assists sponsors and applicants in that if you include your name, contact
DEPARTMENT OF HEALTH AND generating and submitting meeting information, or other information that
HUMAN SERVICES requests and the associated meeting identifies you in the body of your
packages to FDA for biosimilar comments, that information will be
Food and Drug Administration biological products. This guidance posted on http://www.regulations.gov.
finalizes the draft guidance issued on • If you want to submit a comment
[Docket No. FDA–2013–D–0286] April 1, 2013. with confidential information that you
Formal Meetings Between the Food DATES: Submit either electronic or do not wish to be made available to the
and Drug Administration and written comments on Agency guidances public, submit the comment as a
Biosimilar Biological Product at any time. written/paper submission and in the
Sponsors or Applicants; Guidance for ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper
Industry; Availability as follows: Submissions’’ and ‘‘Instructions’’).
AGENCY: Food and Drug Administration, Electronic Submissions Written/Paper Submissions
HHS. Submit electronic comments in the Submit written/paper submissions as
ACTION: Notice of availability. following way: follows:
• Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug www.regulations.gov. Follow the written/paper submissions): Division of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Administration (FDA or Agency) is instructions for submitting comments. Dockets Management (HFA–305), Food
announcing the availability of a Comments submitted electronically, and Drug Administration, 5630 Fishers
guidance for industry entitled ‘‘Formal including attachments, to http:// Lane, rm. 1061, Rockville, MD 20852.
Meetings Between the FDA and www.regulations.gov will be posted to • For written/paper comments
Biosimilar Biological Product Sponsors the docket unchanged. Because your submitted to the Division of Dockets
or Applicants.’’ This guidance provides comment will be made public, you are Management, FDA will post your
recommendations to industry on formal solely responsible for ensuring that your comment, as well as any attachments,
meetings between FDA and sponsors or comment does not include any except for information submitted,
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![72070 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
marked and identified, as confidential, Drug Administration, 10001 New connection with the new user fee
if submitted as detailed in Hampshire Ave., Hillandale Building, program. The performance goals, which
‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– are set forth in a letter from the
Instructions: All submissions received 0002 or Office of Communication, Secretary of Health and Human Services
must include the Docket No. [FDA– Outreach, and Development, Center for to the Chairman of the Committee on
2013–D–0286] for Formal Meetings Biologics Evaluation and Research, Health, Education, Labor, and Pensions
Between the FDA and Biosimilar Food and Drug Administration, 10903 of the Senate and the Chairman of the
Biological Product Sponsors or New Hampshire Ave., Bldg. 71, Rm. Committee on Energy and Commerce of
Applicants; Guidance for Industry; 3128, Silver Spring, MD 20993–0002. the House of Representatives,1 include
Availability. Received comments will be Send one self-addressed adhesive label meeting management goals for formal
placed in the docket and, except for to assist that office in processing your meetings that occur between FDA and
those submitted as ‘‘Confidential requests. See the SUPPLEMENTARY sponsors or applicants during the
Submissions,’’ publicly viewable at INFORMATION section for electronic development phase of a biosimilar
http://www.regulations.gov or at the access to the guidance document. biological product. This guidance
Division of Dockets Management FOR FURTHER INFORMATION CONTACT: Neel describes the Agency’s current thinking
between 9 a.m. and 4 p.m., Monday Patel, Center for Drug Evaluation and on how it intends to interpret and apply
through Friday. Research, Food and Drug certain provisions of BsUFA, and also
• Confidential Submissions—To provides information on specific
Administration, 10903 New Hampshire
submit a comment with confidential performance goals for the management
Ave., Bldg. 22, Rm. 6483, Silver Spring,
information that you do not wish to be of meetings associated with the
MD 20993–0002, 301–796–0970; or
made publicly available, submit your development and review of biosimilar
Stephen Ripley, Center for Biologics
comments only as a written/paper biological products.
Evaluation and Research, Food and
submission. You should submit two This guidance reflects a unified
Drug Administration, 10903 New
copies total. One copy will include the approach to all formal meetings between
Hampshire Ave., Bldg. 71, Rm. 7301,
information you claim to be confidential sponsors or applicants and FDA for
with a heading or cover note that states Silver Spring, MD 20993–0002, 240–
biosimilar biological product
‘‘THIS DOCUMENT CONTAINS 402–7911.
development (BPD) programs. It is
CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION: intended to assist sponsors and
Agency will review this copy, including I. Background applicants in generating and submitting
the claimed confidential information, in a meeting request and the associated
its consideration of comments. The FDA is announcing the availability of meeting package to FDA for biosimilar
second copy, which will have the a guidance for industry entitled ‘‘Formal biological products. This guidance does
claimed confidential information Meetings Between the FDA and not apply to new drug or abbreviated
redacted/blacked out, will be available Biosimilar Biological Product Sponsors new drug applications under section
for public viewing and posted on or Applicants.’’ This guidance provides 505 of the FD&C Act or to biologics
http://www.regulations.gov. Submit recommendations to industry on formal license applications under section
both copies to the Division of Dockets meetings between FDA and sponsors or 351(a) of the PHS Act.
Management. If you do not wish your applicants relating to the development FDA expects that review staff will
name and contact information to be and review of biosimilar biological participate in many meetings with
made publicly available, you can products regulated by CDER and CBER. biosimilar biological product sponsors
provide this information on the cover For the purposes of this guidance, or applicants who seek guidance
sheet and not in the body of your ‘‘formal meeting’’ includes any meeting relating to the development and review
comments and you must identify this that is requested by a sponsor or of biosimilar biological products.
information as ‘‘confidential.’’ Any applicant following the request Because these meetings often will
information marked as ‘‘confidential’’ procedures provided in this guidance represent critical points in the
will not be disclosed except in and includes meetings conducted in any regulatory process, it is important that
accordance with 21 CFR 10.20 and other format (i.e., face to face, teleconference, there are efficient, consistent procedures
applicable disclosure law. For more or videoconference). for the timely and effective conduct of
information about FDA’s posting of The Biologics Price Competition and such meetings. The good meeting
comments to public dockets, see 80 FR Innovation Act of 2009 amended the management practices in this guidance
56469, September 18, 2015, or access Public Health Service Act (PHS Act) and are intended to provide consistent
the information at: http://www.fda.gov/ other statutes to create an abbreviated procedures that will promote well-
regulatoryinformation/dockets/ licensure pathway in section 351(k) of managed meetings and to ensure that
default.htm. the PHS Act (42 U.S.C. 262(k)) for such meetings are scheduled within a
Docket: For access to the docket to biological products shown to be reasonable time, conducted efficiently,
read background documents or the biosimilar to, or interchangeable with, and documented appropriately. The
electronic and written/paper comments an FDA-licensed biological product (see following five meeting types that occur
received, go to http:// sections 7001 through 7003 of the between sponsors or applicants and
www.regulations.gov and insert the Patient Protection and Affordable Care FDA staff during the biosimilar BPD
docket number, found in brackets in the Act (Pub. L. 111–148)). The Biosimilar phase are described in the guidance: (1)
heading of this document, into the User Fee Act of 2012 (BsUFA), enacted Biosimilar Initial Advisory meeting; (2)
asabaliauskas on DSK5VPTVN1PROD with NOTICES
‘‘Search’’ box and follow the prompts as part of the Food and Drug BPD Type 1 meeting; (3) BPD Type 2
and/or go to the Division of Dockets Administration Safety and Innovation meeting; (4) BPD Type 3 meeting; and
Management, 5630 Fishers Lane, Rm. Act (Pub. L. 112–144), amended the (5) BPD Type 4 meeting.
1061, Rockville, MD 20852. Federal Food, Drug, and Cosmetic Act
Submit written requests for single (the FD&C Act) to authorize a new user 1 See http://www.fda.gov/downloads/Drugs/
copies of this guidance to the Division fee program for biosimilar biological DevelopmentApprovalProcess/HowDrugsare
DevelopedandApproved/ApprovalApplications/
of Drug Information, Center for Drug products. FDA has committed to TherapeuticBiologicApplications/Biosimilars/
Evaluation and Research, Food and meeting certain performance goals in UCM281991.pdf.
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![Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72071
On April 1, 2013 (78 FR 19492), FDA SUMMARY: The Food and Drug comment, as well as any attachments,
announced the availability of a draft Administration (FDA) is announcing an except for information submitted,
version of this guidance. All comments opportunity for public comment on the marked and identified, as confidential,
received during the comment period for proposed collection of certain if submitted as detailed in
the draft guidance have been reviewed information by the Agency. Under the ‘‘Instructions.’’
and, where appropriate, incorporated Paperwork Reduction Act of 1995 (the Instructions: All submissions received
into this guidance. As a result of the PRA), Federal Agencies are required to must include the Docket No. FDA–
public comments, information has been publish notice in the Federal Register 2012–N–0921 for ‘‘Agency Information
added to provide clarity on the process concerning each proposed collection of Collection Activities; Proposed
for requesting meetings, including information, including each proposed Collection; Comment Request;
identifying the appropriate meeting extension of an existing collection of Electronic Submission of Food and Drug
type, and the data expectations to information, and to allow 60 days for Administration Adverse Event Reports
support the appropriate meeting type. public comment in response to the and Other Safety Information Using the
This guidance is being issued notice. This notice solicits comments on Electronic Submission Gateway and the
consistent with FDA’s good guidance the use of the FDA Electronic Safety Reporting Portal.’’ Received
practices regulation (21 CFR 10.115). Submission Gateway (ESG) and the comments will be placed in the docket
The guidance represents the current Safety Reporting Portal (SRP) to collect and, except for those submitted as
thinking of FDA on formal meetings adverse event reports and other safety ‘‘Confidential Submissions,’’ publicly
between FDA and biosimilar biological information for FDA-regulated products. viewable at http://www.regulations.gov
product sponsors or applicants. It does DATES: Submit either electronic or or at the Division of Dockets
not establish any rights for any person written comments on the collection of Management between 9 a.m. and 4 p.m.,
and is not binding on FDA or the public. information by January 19, 2016. Monday through Friday.
You can use an alternative approach if ADDRESSES: You may submit comments • Confidential Submissions—To
it satisfies the requirements of the as follows: submit a comment with confidential
applicable statutes and regulations. information that you do not wish to be
Electronic Submissions made publicly available, submit your
II. Paperwork Reduction Act of 1995
Submit electronic comments in the comments only as a written/paper
This guidance contains information following way: submission. You should submit two
collection provisions that are subject to • Federal eRulemaking Portal: http:// copies total. One copy will include the
review by the Office of Management and www.regulations.gov. Follow the information you claim to be confidential
Budget (OMB) under the Paperwork instructions for submitting comments. with a heading or cover note that states
Reduction Act of 1995 (44 U.S.C. 3501– Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS
3520). The collection of information in including attachments, to http:// CONFIDENTIAL INFORMATION’’. The
this guidance was approved under OMB www.regulations.gov will be posted to Agency will review this copy, including
control number 0910–0802. the docket unchanged. Because your the claimed confidential information, in
III. Electronic Access comment will be made public, you are its consideration of comments. The
solely responsible for ensuring that your second copy, which will have the
Persons with access to the Internet claimed confidential information
comment does not include any
may obtain the guidance at http:// redacted/blacked out, will be available
confidential information that you or a
www.fda.gov/Drugs/Guidance for public viewing and posted on
third party may not wish to be posted,
ComplianceRegulatoryInformation/ http://www.regulations.gov. Submit
such as medical information, your or
Guidances/default.htm, http:// both copies to the Division of Dockets
anyone else’s Social Security number, or
www.fda.gov/BiologicsBloodVaccines/ Management. If you do not wish your
confidential business information, such
GuidanceComplianceRegulatory name and contact information to be
as a manufacturing process. Please note
Information/default.htm, or http:// made publicly available, you can
that if you include your name, contact
www.regulations.gov. provide this information on the cover
information, or other information that
Dated: November 13, 2015. identifies you in the body of your sheet and not in the body of your
Leslie Kux, comments, that information will be comments and you must identify this
Associate Commissioner for Policy. posted on http://www.regulations.gov. information as ‘‘confidential.’’ Any
[FR Doc. 2015–29455 Filed 11–17–15; 8:45 am] • If you want to submit a comment information marked as ‘‘confidential’’
BILLING CODE 4164–01–P with confidential information that you will not be disclosed except in
do not wish to be made available to the accordance with 21 CFR 10.20 and other
public, submit the comment as a applicable disclosure law. For more
DEPARTMENT OF HEALTH AND written/paper submission and in the information about FDA’s posting of
HUMAN SERVICES manner detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
Food and Drug Administration the information at: http://www.fda.gov/
Written/Paper Submissions regulatoryinformation/dockets/
[Docket No. FDA–2012–N–0921] Submit written/paper submissions as default.htm.
follows: Docket: For access to the docket to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Information Collection • Mail/Hand delivery/Courier (for read background documents or the
Activities; Proposed Collection; written/paper submissions): Division of electronic and written/paper comments
Comment Request; Adverse Event Dockets Management (HFA–305), Food received, go to http://
Reporting; Electronic Submissions and Drug Administration, 5630 Fishers www.regulations.gov and insert the
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
HHS. • For written/paper comments heading of this document, into the
submitted to the Division of Dockets ‘‘Search’’ box and follow the prompts
ACTION: Notice.
Management, FDA will post your and/or go to the Division of Dockets
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Document Created: 2018-03-01 11:20:39
Document Modified: 2018-03-01 11:20:39
| 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 Agency guidances at any time. | |
| Contact | Neel Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6483, Silver Spring, MD 20993-0002, 301-796-0970; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 80 FR 72069 |
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