80 FR 18629 - Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 66 (April 7, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 66 (April 7, 2015)
| Page Range | 18629-18631 | |
| FR Document | 2015-08015 |
[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)] [Notices] [Pages 18629-18631] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08015] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1747] Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS. There are different procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA review and action of such changes. In addition, this guidance provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. The definitions of REMS modifications and revisions apply to all types of REMS. 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 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the guidance by June 8, 2015. Submit either electronic or written comments concerning the proposed collection of information by June 8, 2015. ADDRESSES: Submit written requests for single copies of the 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 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 guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kristen Everett, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301- 796-0453; 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 ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on what types of changes to approved REMS will be considered modifications and what types of changes will be considered revisions. See section 505-1(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355- 1(h)). This guidance also provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. If FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh its risks, FDA is authorized to require a REMS for such drugs under section 505-1 of the FD&C Act,\1\ added by section 901 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85).\2\ Section 505-1(g) and (h) of the FD&C Act include provisions for the assessment and modification of an approved REMS. --------------------------------------------------------------------------- \1\ Section 505-1 of the FD&C Act applies to applications for prescription drugs submitted under subsection 505(b) (i.e., new drug applications) or (j) (i.e., abbreviated new drug applications) of the FD&C Act (21 U.S.C. 355) and applications under section 351 of the Public Health Service Act (i.e., biologics license applications). \2\ See http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm. --------------------------------------------------------------------------- In 2009, FDA issued draft guidance on the format and content of REMS, REMS assessments, and proposed REMS modifications. In that guidance, based on the language of section 505-1(g) and (h) of the FD&C Act before the amendments made by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA), FDA stated that any proposed modification to an approved REMS, including proposed changes to materials that are appended to the REMS document, must be submitted as a proposed REMS modification in the form of a prior approval supplement and must include a REMS assessment. The guidance stated that the proposed [[Page 18630]] modification(s) may not be implemented until approved by FDA. FDASIA amended the REMS modification provisions under section 505- 1(g) and (h) of the FD&C Act. Section 505-1(h), as amended by FDASIA, requires FDA to review and act on proposed ``minor modifications,'' as defined in guidance, within 60 days.\3\ It also requires FDA to establish, through guidance, that ``certain modifications'' can be implemented following notification to FDA.\4\ In addition, FDASIA requires FDA to review and act on REMS modifications due to approved safety label changes, or to a safety label change that FDA has directed the application holder to make pursuant to section 505(o)(4) of the FD&C Act within 60 days.\5\ Finally, FDASIA specifies that proposed REMS modifications no longer require submission of a REMS assessment; instead, proposed modifications must include an adequate rationale for the proposed changes. This guidance is issued pursuant to section 505- 1(h)(2)(A)(ii), (h)(2)(A)(iii), and (h)(2)(A)(iv) of the FD&C Act. --------------------------------------------------------------------------- \3\ See section 505-1(h)(2)(A)(ii) of the FD&C Act. \4\ See section 505-1(h)(2)(A)(iv) of the FD&C Act. \5\ See section 505-1(h)(2)(A)(iii) of the FD&C Act. --------------------------------------------------------------------------- This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance, except for the portion setting forth the submission procedures for REMS revisions, is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). The Agency made this determination because, consistent with the requirements of FDASIA, FDA is issuing this guidance to establish a less burdensome policy and process for submitting certain changes to REMS that is consistent with public health. Although the guidance document is immediately in effect, except for the submission procedures for REMS revisions, it remains subject to comment in accordance with the Agency's good guidance practices. Insofar as this guidance establishes the modifications to an approved REMS that may be implemented following notification to the Secretary under section 505-1(h)(2)(A)(iv)--here referred to as REMS revisions-- it has binding effect, except for the portion of the guidance setting forth the submission procedure for REMS revisions, which will, when final, have binding effect. 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 title, description, and respondent description of the information collection are given under this section with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. We invite 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. Title: Guidance for Industry on Risk Evaluation and Mitigation Strategies: Modifications and Revisions Description: The guidance provides information on submitting to FDA modifications and revisions to approved REMS for approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), or biologics license applications (BLAs). REMS modifications are submitted to FDA as supplements to approved NDAs under 21 CFR 314.70 and for ANDAs under 21 CFR 314.97, and as supplements to approved BLAs under 21 CFR 601.12. The burden hours for preparing and submitting supplements to NDAs and ANDAs is approved by OMB under control number 0910-0001, and for BLAs under control number 0910-0338. Concerning REMS revisions, application holders should include the following information in each submission: (1) A full description of the changes to the REMS and/or appended materials, the date the changes will be implemented, and a REMS history that outlines all changes made to the REMS since its approval; (2) a clean Word version of the revised REMS and all appended REMS materials; (3) a redlined (tracked changes) Word version of the revised REMS and revised appended REMS materials that shows the changes from the previous versions; (4) an updated REMS supporting document, if needed; and (5) Form FDA 356h indicating that the submission is a REMS revision. (Form FDA 356h is approved by OMB under control number 0910-0338.) Each REMS revision that is submitted to FDA should also be documented in the next annual report for the application under 21 CFR 314.81(b)(2) (the burden hours for preparing and submitting annual reports for NDAs and ANDAs is approved by OMB under control number 0910-0001, and for BLAs under control number 0910- 0338). All subsequent REMS submissions (i.e., proposed modifications or additional REMS revisions) should include previously implemented REMS revisions in the REMS document and appended materials, and should be noted in the REMS history. Currently, there are 117 application holders with approved REMS that include 152 drugs. Based on FDA's current review of REMS submissions for approved NDAs, ANDAs, and BLAs, and anticipating an average of 1 REMS revision across the entire group of REMS, we estimate that annually a total of approximately 117 application holders (``Number of Respondents'' in table 1) will submit to FDA approximately 152 REMS revision submissions (``Total Annual Responses'' in table 1) as described in this document and in the guidance. We also estimate that it will take an application holder approximately 30 hours to prepare and submit to FDA each REMS revision (``Average Burden per Response'' in table 1). The total estimated reporting burden for the guidance is as follows: [[Page 18631]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Guidance for industry on risk evaluation and mitigation strategies: Number of responses per Total annual Average burden Total hours modifications and revisions respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- REMS revisions..................................................... 117 1 152 30 4,560 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: April 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-08015 Filed 4-6-15; 8:45 am] BILLING CODE CODE 4164-01-P
![Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 18629
FOR FURTHER INFORMATION CONTACT: ACTION: Notice. Drug Administration, 10903 New
Larry Bauer, Rare Diseases Program, Hampshire Ave. Bldg. 22, Rm. 6484,
Center for Drug Evaluation and SUMMARY: The Food and Drug Silver Spring, MD 20993–0002, 301–
Research, Food and Drug Administration (FDA) is announcing the 796–0453; or Stephen Ripley, Center for
Administration, 10903 New Hampshire availability of a guidance for industry Biologics Evaluation and Research,
Ave., Silver Spring, MD 20993–0002, entitled ‘‘Risk Evaluation and Mitigation Food and Drug Administration, 10903
301–796–4842, FAX: 301–796–9858, Strategies: Modifications and New Hampshire Ave. Bldg. 71, Rm.
email: larry.bauer@fda.hhs.gov. Revisions.’’ This guidance provides 7301, Silver Spring, MD 20993–0002,
information on how FDA will define 240–402–7911.
SUPPLEMENTARY INFORMATION: FDA is
and process submissions for
announcing the issuance of a priority SUPPLEMENTARY INFORMATION:
modifications and revisions to risk
review voucher to the sponsor of a rare
evaluation and mitigation strategies I. Background
pediatric disease product application.
(REMS), as well as information on what
Under section 529 of the FD&C Act (21 FDA is announcing the availability of
types of changes to approved REMS will
U.S.C. 360ff), added by FDASIA, FDA a guidance for industry entitled ‘‘Risk
be considered modifications of the
will award priority review vouchers to Evaluation and Mitigation Strategies:
REMS and what types of changes will be
sponsors of rare pediatric disease Modifications and Revisions.’’ This
considered revisions of the REMS.
product applications that meet certain guidance provides information on what
There are different procedures for
criteria. FDA has determined that types of changes to approved REMS will
submission of REMS modifications and
UNITUXIN (dinutuximab), be considered modifications and what
revisions to FDA as well as different
manufactured by United Therapeutics types of changes will be considered
timeframes for FDA review and action
Corporation, meets the criteria for a revisions. See section 505–1(h) of the
of such changes. In addition, this
priority review voucher. UNITUXIN Federal Food, Drug, and Cosmetic Act
guidance provides information on how
(dinutuximab) is indicated, in (the FD&C Act) (21 U.S.C. 355–1(h)).
REMS modifications and revisions
combination with granulocyte- This guidance also provides information
should be submitted to FDA and how
macrophage colony-stimulating factor on how REMS modifications and
FDA intends to review and act on these
(GM–CSF), interleukin-2 (IL–2), and 13- revisions should be submitted to FDA
submissions. The definitions of REMS
cis-retinoic acid (RA), for the treatment and how FDA intends to review and act
modifications and revisions apply to all
of pediatric patients with high-risk on these submissions.
types of REMS.
neuroblastoma who achieve at least a If FDA determines that a REMS is
partial response to prior first-line DATES: Although you can comment on necessary to ensure that the benefits of
multiagent, multimodality therapy. any guidance at any time (see 21 CFR a drug outweigh its risks, FDA is
Neuroblastoma is the most common 10.115(g)(5)), to ensure that the Agency authorized to require a REMS for such
pediatric solid tumor occurring outside considers your comment on this drugs under section 505–1 of the FD&C
the brain, and it is the most common guidance before it begins work on the Act,1 added by section 901 of the Food
cancer in infants. final version of the guidance, submit and Drug Administration Amendments
For further information about the Rare either electronic or written comments Act of 2007 (Pub. L. 110–85).2 Section
Pediatric Disease Priority Review on the guidance by June 8, 2015. Submit 505–1(g) and (h) of the FD&C Act
Voucher Program and for a link to the either electronic or written comments include provisions for the assessment
full text of section 529 of the FD&C Act, concerning the proposed collection of and modification of an approved REMS.
go to http://www.fda.gov/ForIndustry/ information by June 8, 2015. In 2009, FDA issued draft guidance on
DevelopingProductsforRareDiseases ADDRESSES: Submit written requests for the format and content of REMS, REMS
Conditions/RarePediatricDiseasePriority single copies of the guidance to the assessments, and proposed REMS
VoucherProgram/default.htm. Division of Drug Information, Center for modifications. In that guidance, based
For further information about Drug Evaluation and Research, Food on the language of section 505–1(g) and
UNITUXIN (dinutuximab), go to the and Drug Administration, 10001 New (h) of the FD&C Act before the
Drugs@FDA Web site at http://www. Hampshire Ave. Hillandale Building, amendments made by the Food and
accessdata.fda.gov/scripts/cder/ 4th Floor, Silver Spring, MD 20993– Drug Administration Safety and
drugsatfda/index.cfm. 0002; or the Office of Communication, Innovation Act (Pub. L. 112–144)
Dated: April 2, 2015. Outreach, and Development, Center for (FDASIA), FDA stated that any
Leslie Kux,
Biologics Evaluation and Research, proposed modification to an approved
Food and Drug Administration, 10903 REMS, including proposed changes to
Associate Commissioner for Policy.
New Hampshire Ave. Bldg. 71, Rm. materials that are appended to the
[FR Doc. 2015–08014 Filed 4–6–15; 8:45 am]
3128, Silver Spring, MD 20993–0002. REMS document, must be submitted as
BILLING CODE CODE 4164–01–P Send one self-addressed adhesive label a proposed REMS modification in the
to assist that office in processing your form of a prior approval supplement
requests. See the SUPPLEMENTARY and must include a REMS assessment.
DEPARTMENT OF HEALTH AND INFORMATION section for electronic
HUMAN SERVICES The guidance stated that the proposed
access to the guidance document.
Food and Drug Administration Submit electronic comments on the 1 Section 505–1 of the FD&C Act applies to
guidance to http://www.regulations.gov. applications for prescription drugs submitted under
[Docket No. FDA–2014–D–1747] Submit written comments to the subsection 505(b) (i.e., new drug applications) or (j)
mstockstill on DSK4VPTVN1PROD with NOTICES
Division of Dockets Management (HFA– (i.e., abbreviated new drug applications) of the
Risk Evaluation and Mitigation FD&C Act (21 U.S.C. 355) and applications under
305), Food and Drug Administration, section 351 of the Public Health Service Act (i.e.,
Strategies: Modifications and 5630 Fishers Lane, Rm. 1061, Rockville, biologics license applications).
Revisions; Guidance for Industry; MD 20852. 2 See http://www.fda.gov/RegulatoryInformation/
Availability Legislation/FederalFoodDrugand
FOR FURTHER INFORMATION CONTACT:
CosmeticActFDCAct/SignificantAmendmentsto
AGENCY: Food and Drug Administration, Kristen Everett, Center for Drug theFDCAct/FoodandDrugAdministration
HHS. Evaluation and Research, Food and AmendmentsActof2007/default.htm.
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![Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 18631
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Guidance for industry on risk evaluation and mitigation Number of Total annual
responses per burden per Total hours
strategies: modifications and revisions respondents responses
respondent response
REMS revisions ................................................................... 117 1 152 30 4,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments National Health Service Corps Loan Fishers Lane, Room 11W–37, Rockville,
Interested persons may submit either Repayment Program (NHSC LRP), MD 20857, Telephone: 301–443–1587.
electronic comments regarding this Students to Service, (S2S), NHSC SUPPLEMENTARY INFORMATION:
document to http://www.regulations.gov Student/Resident Experiences and
or written comments to the Division of Rotations in Community Health I. Explanation of Changes
(SEARCH), NURSE Corps Loan
Dockets Management (see ADDRESSES). It
Repayment Program (NURSE Corps • The system of records notice name
is only necessary to send one set of has been shortened to ‘‘HHS/HRSA/
comments. Identify comments with the LRP) formerly the Nursing Education
Loan Repayment Program (NELRP), BHW Scholarship and Loan Repayment
docket number found in brackets in the Program Records.’’
heading of this document. Received NURSE Corps Scholarship Program
(NURSE Corps SP) formerly the Nursing • The Nursing Scholarship Program
comments may be seen in the Division (NSP) has been renamed the NURSE
of Dockets Management between 9 a.m. Scholarship Program (NSP), Native
Hawaiian Health Scholarship Program Corps Scholarship Program (NURSE
and 4 p.m., Monday through Friday, and Corps SP), and the Nursing Education
will be posted to the docket at http:// (NHHSP), and Faculty Loan Repayment
Program (FLRP), Applicants and/or Loan Repayment Program (NELRP) has
www.regulations.gov. been renamed the NURSE Corps Loan
Participants Records System, HHS/
IV. Electronic Access HRSA/BHW,’’ No. 09–15–0037. The Repayment Program (NURSE Corps
Persons with access to the Internet proposed alterations affect the system LRP) and all associated records have
may obtain the document at http:// name, system location, categories of been merged into a new central database
www.fda.gov/Drugs/ records, purposes, routine uses, system as noted below.
GuidanceCompliance safeguards, records retention and • A new information system, BHW
RegulatoryInformation/Guidances/ disposal, system manager title and Management Information System
default.htm, http://www.fda.gov/ address, as well as minor editorial Solution (BMISS), has replaced Bureau
BiologicsBloodVaccines/ corrections and clarifications. of Health Care Delivery and Assistance
GuidanceCompliance DATES: HRSA filed an altered system NET (BHCDANET), and serves as the
RegulatoryInformation/default.htm, or report with the Chair of the House central database for information
http://www.regulations.gov. Committee on Government Reform and concerning the, NHSC SP, NHSC LRP,
Oversight, the Chair of the Senate S2S, NURSE Corps SP, NURSE Corps
Dated: April 2, 2015.
Committee on Homeland Security and LRP, FLRP, and NHHSP.
Leslie Kux,
Governmental Affairs, and the • The system location section has
Associate Commissioner for Policy.
Administrator, Office of Information been updated to indicate that electronic
[FR Doc. 2015–08015 Filed 4–6–15; 8:45 am]
and Regulatory Affairs, Office of records and electronic copies of paper
BILLING CODE CODE 4164–01–P
Management and Budget (OMB) on records for applicants and participants
March 30, 2015. To ensure all parties under various programs are now stored
have adequate time in which to in BMISS and to include locations of
DEPARTMENT OF HEALTH AND
comment, the altered system, including records not stored in BMISS (for
HUMAN SERVICES
the routine uses, will become effective example, Ambassador records are
Health Resources and Services 30 days from the publication of the electronic but currently maintained in
Administration notice or 40 days from the date it was an online Web site directory while a
submitted to OMB and Congress, BMISS database is being designed and
Privacy Act of 1974; Report of an whichever is later, unless HRSA built, at which point the records will be
Altered System of Records receives comments that require merged into BMISS).
AGENCY: Health Resources and Services
alterations to this notice. • The categories of records have been
Administration (HRSA), Department of ADDRESSES: Please address comments updated to include ‘‘information
Health and Human Services (HHS or to: Associate Administrator, Bureau of concerning educational loans.’’
Department). Health Workforce (BHW), Health • The purpose(s) section has been
Resources and Services Administration updated to consolidate certain
ACTION: Notice of an Altered System of
(HRSA), 5600 Fishers Lane, Room 11W– descriptions (i.e., to combine the loan
Records. 37, Rockville, MD 20857, telephone repayment and scholarship program
SUMMARY: In accordance with the (301) 594–4130, or FAX (301) 594–4076. monitoring activities previously
Comments received will be available for
mstockstill on DSK4VPTVN1PROD with NOTICES
requirements of the Privacy Act of 1974 described in purpose 4 with the other
(5 U.S.C. 552a), the Health Resources inspection at this same address from program selection and monitoring
and Services Administration (HRSA) is 9:00 a.m. to 3:00 p.m. (Eastern Standard activities previously described in
publishing notice of a proposed Time Zone), Monday through Friday. purpose 8), and to include intra-agency
alteration of the system of records FOR FURTHER INFORMATION CONTACT: transfers of information previously
entitled and numbered ‘‘Public Health BMISS System Manager, Bureau of described as routine uses by mistake
and National Health Service Corps Health Workforce, Health Resources and (i.e., transfers to HHS’ debt and
Scholarship Program (NHSC SP), Services Administration (HRSA), 5600 financial management systems).
VerDate Sep<11>2014 17:46 Apr 06, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\07APN1.SGM 07APN1](https://thefederalregister.org/doc/80_FR_18695/page/3.svg)
Document Created: 2018-02-21 10:05:31
Document Modified: 2018-02-21 10:05:31
| 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 | 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 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the guidance by June 8, 2015. Submit either electronic or written comments concerning the proposed collection of information by June 8, 2015. | |
| Contact | Kristen Everett, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301- 796-0453; 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 18629 |
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