82 FR 53505 - Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 220 (November 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 220 (November 16, 2017)
| Page Range | 53505-53507 | |
| FR Document | 2017-24831 |
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)] [Notices] [Pages 53505-53507] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24831] [[Page 53505]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6209] Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain intended changes in policies and procedures surrounding its application. DATES: Submit either electronic or written comments on the draft guidance by January 16, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-6209 for ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' 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 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; or to the 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Beena Alex, Division of User Fee Management and Budget Formulation, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900, [email protected]; or to 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 draft guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This draft guidance concerns the implementation of BsUFA II, including an explanation about the new fee structure and types of fees for which entities are responsible. BsUFA II extends FDA's authority to collect user fees from fiscal year 2018 to 2022 and introduces a number of technical revisions that affect what fees are collected and how fees are collected. Fees authorized by this legislation help fund the process for the review of biosimilar biological product applications and have played an important role in expediting the review and approval process. BsUFA II authorizes biosimilar biological product development [[Page 53506]] program fees (BPD fees), biosimilar biological product application fees, and biosimilar biological product program fees. This draft guidance describes when these fees are incurred and the process by which applicants can submit payments. The draft guidance also provides information on consequences of failing to pay BsUFA II fees and the processes for submitting reconsideration and appeal requests. 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 assessing user fees under BsUFA II. 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 of 1995 (the PRA) (44 U.S.C. 3501-3520), 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 collection of information associated with this document, 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 of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Assessing User Fees Under the Biosimilar User Fee Amendments of 2017: Draft Guidance for Industry OMB Control Number 0910--NEW This information collection supports ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017: Draft Guidance for Industry.'' The Federal Food, Drug, and Cosmetic Act as amended by the Biosimilar User Fee Act of 2012 and recently renewed in 2017 (BsUFA II) under the FDA Reauthorization Act of 2017, authorizes FDA to assess and collect user fees from companies that produce biosimilar biological products in conjunction with the review of biosimilar biological product applications. The draft guidance includes processing and policies for the initial and the annual BPD fees; the BPD discontinuation process requirements and BPD reactivation fees; process and policies for biosimilar biological product application fees including exceptions to the application fees and refund of fees; process and policies for the small business waiver of the biosimilar application fee; and implementation of the biosimilar biological product program fee. The burdens associated with requesting a small business waiver of BsUFA fees and the associated burdens for new activities as noted in the draft guidance are listed in table 1. FDA estimates the annual burden of these new collections of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total annual burden per Activity respondents responses per responses response Total hours respondent (hours) ---------------------------------------------------------------------------------------------------------------- Request for discontinuation from 2 1 2 1 2 BPD program.................... Request to move products to 5 1 5 .5 2.5 discontinued section of the biosimilar list................ Small business waiver of the 1 1 1 16 16 BsUFA application fee.......... --Reconsiderations.......... 1 1 1 24 24 --Appeals................... 1 1 1 12 12 Annual Fee Determination Survey. 35 1 35 1 35 Annual BsUFA Fees Correspondence 35 1 35 2 70 ------------------------------------------------------------------------------- Total................... .............. .............. .............. .............. 161.5 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. This draft guidance also refers to previously approved collections of information found in FDA forms developed to support its user fee program. Specifically, the draft guidance refers to Form FDA 3792, Form FDA 3913, and Form FDA 3971, which have been approved under OMB control numbers 0910-0718, 0910-0805, and 0910-0693, respectively. The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 312 are currently approved under OMB control number 0910-0014; the collections of information regarding new drug applications and biologics license applications are approved under OMB control numbers 0910-0001 and 0910-0338, respectively. 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, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/ [[Page 53507]] default.htm, or https://www.regulations.gov. Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24831 Filed 11-15-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53505
DEPARTMENT OF HEALTH AND Written/Paper Submissions docket number, found in brackets in the
HUMAN SERVICES Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
Food and Drug Administration • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
[Docket No. FDA–2017–D–6209] Management Staff (HFA–305), Food and Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any
Assessing User Fees Under the Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
Biosimilar User Fee Amendments of • For written/paper comments 10.115(g)(5)).
2017; Draft Guidance for Industry; submitted to the Dockets Management Submit written requests for single
Availability Staff, FDA will post your comment, as copies of the draft guidance to the
well as any attachments, except for Division of Drug Information, Center for
AGENCY: Food and Drug Administration, Drug Evaluation and Research, Food
HHS. information submitted, marked and
identified, as confidential, if submitted and Drug Administration, 10001 New
ACTION: Notice of availability. as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
SUMMARY: The Food and Drug 0002; or to the Office of
Administration (FDA or Agency) is must include the Docket No. FDA–
2017–D–6209 for ‘‘Assessing User Fees Communication, Outreach, and
announcing the availability of a draft Development, Center for Biologics
guidance for industry entitled Under the Biosimilar User Fee
Amendments of 2017.’’ Received Evaluation and Research, Food and
‘‘Assessing User Fees Under the Drug Administration, 10903 New
Biosimilar User Fee Amendments of comments will be placed in the docket
and, except for those submitted as Hampshire Ave., Bldg. 71, Rm. 3128,
2017.’’ This draft guidance concerns Silver Spring, MD 20993–0002. Send
FDA’s implementation of the Biosimilar ‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov one self-addressed adhesive label to
User Fee Amendments of 2017 (BsUFA assist that office in processing your
II) and certain intended changes in or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday requests. See the SUPPLEMENTARY
policies and procedures surrounding its INFORMATION section for electronic
application. through Friday.
• Confidential Submissions—To access to the draft guidance document.
DATES: Submit either electronic or submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
written comments on the draft guidance information that you do not wish to be Beena Alex, Division of User Fee
by January 16, 2018 to ensure that the made publicly available, submit your Management and Budget Formulation,
Agency considers your comment on this comments only as a written/paper Center for Drug Evaluation and
draft guidance before it begins work on submission. You should submit two Research, Food and Drug
the final version of the guidance. copies total. One copy will include the Administration, 10001 New Hampshire
ADDRESSES: You may submit comments information you claim to be confidential Ave., Rm. 2185, Silver Spring, MD
on any guidance at any time as follows: with a heading or cover note that states 20993, 301–796–7900,
‘‘THIS DOCUMENT CONTAINS CDERCollections@fda.hhs.gov; or to
Electronic Submissions
CONFIDENTIAL INFORMATION.’’ The Stephen Ripley, Center for Biologics
Submit electronic comments in the Agency will review this copy, including Evaluation and Research, Food and
following way: the claimed confidential information, in Drug Administration, 10903 New
• Federal eRulemaking Portal: its consideration of comments. The Hampshire Ave., Bldg. 71, Rm. 7301,
https://www.regulations.gov. Follow the second copy, which will have the Silver Spring, MD 20993–0002, 240–
instructions for submitting comments. claimed confidential information 402–7911.
Comments submitted electronically, redacted/blacked out, will be available SUPPLEMENTARY INFORMATION:
including attachments, to https:// for public viewing and posted on
www.regulations.gov will be posted to https://www.regulations.gov. Submit I. Background
the docket unchanged. Because your both copies to the Dockets Management FDA is announcing the availability of
comment will be made public, you are Staff. If you do not wish your name and a draft guidance for industry entitled
solely responsible for ensuring that your contact information to be made publicly ‘‘Assessing User Fees Under the
comment does not include any available, you can provide this Biosimilar User Fee Amendments of
confidential information that you or a information on the cover sheet and not 2017.’’ This draft guidance concerns the
third party may not wish to be posted, in the body of your comments and you implementation of BsUFA II, including
such as medical information, your or must identify this information as an explanation about the new fee
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked structure and types of fees for which
confidential business information, such as ‘‘confidential’’ will not be disclosed entities are responsible. BsUFA II
as a manufacturing process. Please note except in accordance with 21 CFR 10.20 extends FDA’s authority to collect user
that if you include your name, contact and other applicable disclosure law. For fees from fiscal year 2018 to 2022 and
information, or other information that more information about FDA’s posting introduces a number of technical
identifies you in the body of your of comments to public dockets, see 80 revisions that affect what fees are
comments, that information will be
asabaliauskas on DSKBBXCHB2PROD with NOTICES
FR 56469, September 18, 2015, or access collected and how fees are collected.
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ Fees authorized by this legislation help
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- fund the process for the review of
with confidential information that you 23389.pdf. biosimilar biological product
do not wish to be made available to the Docket: For access to the docket to applications and have played an
public, submit the comment as a read background documents or the important role in expediting the review
written/paper submission and in the electronic and written/paper comments and approval process.
manner detailed (see ‘‘Written/Paper received, go to https:// BsUFA II authorizes biosimilar
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the biological product development
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![Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53507
default.htm, or https:// insert the docket number, found in in the Federal Register of December 31,
www.regulations.gov. brackets in the heading of this 1984 (49 FR 50788), the Office of the
Dated: November 13, 2017. document, into the ‘‘Search’’ box and Commissioner granted the hearing
Anna K. Abram,
follow the prompts and/or go to the request. Following the submission of
Dockets Management Staff, 5630 Fishers written testimony and documentary
Deputy Commissioner for Policy, Planning,
Lane, Rm. 1061, Rockville, MD 20852 evidence, an ALJ, Daniel J. Davidson,
Legislation, and Analysis.
between 9 a.m. and 4 p.m., Monday conducted a hearing from January 14 to
[FR Doc. 2017–24831 Filed 11–15–17; 8:45 am]
through Friday. Publicly available 17, 1986. He issued his Initial Decision
BILLING CODE 4164–01–P
submissions may be seen in the docket. on December 4, 1987. The ALJ found
FOR FURTHER INFORMATION CONTACT: that: (1) The effectiveness of MFC had
Rachael Vieder Linowes, Office of not been proven by substantial evidence
DEPARTMENT OF HEALTH AND
Scientific Integrity, Food and Drug of adequate and well-controlled clinical
HUMAN SERVICES trials, (2) the requirements of the
Administration, 10903 New Hampshire
Food and Drug Administration Ave., Bldg. 1, Rm. 4206, Silver Spring, combination drug policy had not been
MD 20993, 240–402–5931. met, and (3) MFC is a new drug under
[Docket No. FDA–1981–N–0245 (Formerly 21 U.S.C. 321(p). Wyeth timely
81N–0080)] SUPPLEMENTARY INFORMATION:
appealed the ALJ’s Initial Decision by
I. Background filing exceptions with the Commissioner
Mepergan Fortis Capsules; Final under 21 CFR 12.125.
Decision on Proposal To Refuse In 1962, the Federal Food, Drug, and
On August 23, 2017, FDA sent a letter
Approval of Supplemental New Drug Cosmetic Act (the FD&C Act) was
to West-Ward Pharmaceuticals
Application; Availability of Final amended by the Drug Amendments Act
Corporation (West-Ward), successor to
Decision of 1962, and these amendments
Wyeth, to determine whether West-
provided that new drugs could no
AGENCY: Food and Drug Administration; Ward remained interested in pursuing
longer be approved unless both safety its appeal of the ALJ’s Initial Decision.
HHS. and efficacy had been established for FDA informed the company that if it did
ACTION: Notice. them. As amended, the FD&C Act also not respond and affirm its desire to
required FDA to evaluate drugs pursue its appeal by September 21,
SUMMARY: The Food and Drug approved as safe between 1938 and
Administration (FDA or the Agency) is 2017, the Office of the Commissioner
1962 to determine whether such drugs would conclude that West-Ward no
announcing that the Initial Decision of were effective and to withdraw approval
the Administrative Law Judge (ALJ), to longer wishes to pursue the appeal of
for any new drug application (NDA) the ALJ’s Initial Decision and will
refuse approval of the supplemental where there was not substantial
new drug application (sNDA) for proceed as if the appeal has been
evidence of the drug’s effectiveness. The withdrawn. The Office of the
Mepergan Fortis Capsules (MFC) person contesting the withdrawal of the
(meperidine HCl, promethazine HCl), is Commissioner did not receive a
approval had the burden of coming response from West-Ward by the given
the final decision of the Commissioner forward with evidence of effectiveness
by operation of law. In the Initial date; therefore, the Commissioner now
for the drug. FDA’s review of these pre- deems the exceptions withdrawn.
Decision, the ALJ found that MFC had 1962 drugs is known as the Drug
not been shown to be supported by Efficacy Study Implementation (DESI) II. Conclusion and Order
substantial evidence consisting of program. Given that the exceptions have been
adequate and well-controlled studies to In a document published in the deemed withdrawn, this proceeding is
be effective for sedation and analgesia in Federal Register of April 20, 1972 (37 now in the same procedural posture as
patients with concurrent moderate pain FR 7827), after evaluating reports if no exceptions had ever been filed.
and apprehension, such as received from the National Academy of When parties do not file exceptions to
postoperative and post-trauma patients Sciences/National Research Council, the ALJ’s Initial Decision, and the
with those symptoms; that the drug did Drug Efficacy Study Group, and other Commissioner does not file a notice of
not satisfy the combination drug policy; available evidence, FDA classified MFC review, the ALJ’s Initial Decision
and that it is a ‘‘new drug.’’ The sNDA as ‘‘possibly effective’’ for moderate to becomes the final decision of the
applicant filed exceptions to the ALJ’s moderately severe pain. This document Commissioner (see 21 CFR 12.120(e)).
Initial Decision. FDA recently requested also stated that no NDA had been FDA will publish a notice in the Federal
that the current owner of the sNDA approved or deemed approved for MFC Register when an initial decision
application affirm its desire to pursue and that additional evidence needed to becomes the final decision of the
the appeal of the ALJ’s Initial Decision; be submitted to FDA to establish MFC’s Commissioner without appeal to or
however, the applicant did not affirm its effectiveness. Thereafter, Wyeth, a review by the Commissioner (see 21
desire to pursue the appeal within the division of American Home Products CFR 12.120(f)).
specified timeframe. Accordingly, FDA (Wyeth), submitted a supplement to its Therefore, the ALJ’s Initial Decision is
now deems those exceptions as approved NDA 11–730 (Mepergan the final decision of the Commissioner
withdrawn. Consequently, the Injection) for MFC (NDA 11–730, S– effective November 16, 2017. Pursuant
proceeding is in the same procedural 003). In a document published in the to the findings in the ALJ’s Initial
position as if no exceptions to the ALJ’s
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register of September 18, 1981 Decision, under section 505(d) of the
Initial Decision had been filed; (46 FR 46404), the Director of the FD&C Act (21 U.S.C. 355(d)) and under
therefore, the ALJ’s Initial Decision has Bureau of Drugs (now the Center for the authority delegated by the Secretary
become the final decision of the Drug Evaluation and Research) of Health and Human Services, the
Commissioner by operation of law. proposed to refuse approval of the Commissioner finds that there is a lack
DATES: This final decision is effective sNDA and offered Wyeth the of substantial evidence that MFC will
November 16, 2017. opportunity for a hearing. have the effect it purports or is
ADDRESSES: For access to the docket, go Wyeth submitted its request for a represented to have under the
to https://www.regulations.gov and hearing and, by a document published conditions of use prescribed,
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Document Created: 2017-11-16 03:53:46
Document Modified: 2017-11-16 03:53:46
| 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 January 16, 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 | Beena Alex, Division of User Fee Management and Budget Formulation, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900, [email protected]; or to 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 | 82 FR 53505 |
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