80 FR 15217 - Electronic Submission of Lot Distribution Reports; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 55 (March 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 55 (March 23, 2015)
| Page Range | 15217-15218 | |
| FR Document | 2015-06498 |
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)] [Notices] [Pages 15217-15218] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06498] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1288] Electronic Submission of Lot Distribution Reports; 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 document entitled ``Electronic Submission of Lot Distribution Reports; Guidance for Industry.'' The guidance document provides information and recommendations pertaining to the electronic submission of lot distribution reports for applicants with approved biologics license applications (BLAs). FDA recently published in the Federal Register a final rule requiring that, among other things, lot distribution reports be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014, and is intended to help licensed manufacturers of products distributed under an approved BLA (henceforth referred to as applicants) comply with the final rule. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002 or Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. 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: Lori J. Churchyard, 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; or Jared Lantzy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1116, Silver Spring, MD 20993, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ``Electronic Submission of Lot Distribution Reports; Guidance for Industry.'' The guidance provides information and recommendations pertaining to the electronic submission of lot distribution reports. The guidance provides information on how to electronically submit lot distribution reports for biological products under approved BLAs for which CBER or CDER has regulatory responsibility. The guidance does not apply to any other biological product. FDA published in the Federal Register of June 10, 2014 (79 FR 33072), a final rule requiring electronic submission of certain postmarketing submissions. Among other things, under this rule applicants are required to submit biological lot distribution reports to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants subject to lot distribution reporting comply with the final rule. Along with other information, the guidance provides updated information about the following: (1) Structured Product Labeling standard and vocabulary for electronic submission of lot distribution reporting; (2) additional resources such as implementation guide, validation procedures and links with further information; and (3) procedures for requesting temporary waivers from the electronic submission requirement. In the Federal Register of August 29, 2014 (79 FR 51576), FDA announced the availability of the draft guidance entitled '' Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014. FDA published a correction notice to correct the docket number in the Federal Register of September 16, 2014 (79 FR 55497). FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. FDA is finalizing the draft guidance with only editorial changes. The guidance announced in this notice finalizes the draft guidance dated August 2014. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in 21 CFR 600.81 and 600.90 have been approved under 0910-0308. 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 guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. [[Page 15218]] Dated: March 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06498 Filed 3-20-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15217
Dated: March 17, 2015. the SUPPLEMENTARY INFORMATION section Electronic Submission of Lot
Leslie Kux, for electronic access to the guidance Distribution Reports’’ dated August
Associate Commissioner for Policy. document. 2014. FDA published a correction notice
[FR Doc. 2015–06497 Filed 3–20–15; 8:45 am] Submit electronic comments on the to correct the docket number in the
BILLING CODE 4164–01–P
guidance to http://www.regulations.gov. Federal Register of September 16, 2014
Submit written comments to the (79 FR 55497). FDA received a few
Division of Dockets Management (HFA– comments on the draft guidance and
DEPARTMENT OF HEALTH AND 305), Food and Drug Administration, those comments were considered as the
HUMAN SERVICES 5630 Fishers Lane, Rm. 1061, Rockville, guidance was finalized. FDA is
MD 20852. finalizing the draft guidance with only
Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Lori editorial changes. The guidance
[Docket No. FDA–2014–D–1288] J. Churchyard, Center for Biologics announced in this notice finalizes the
Evaluation and Research, Food and draft guidance dated August 2014.
Electronic Submission of Lot Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, The guidance is being issued
Distribution Reports; Guidance for
Industry; Availability Silver Spring, MD 20993–0002, 240– consistent with FDA’s good guidance
402–7911; or Jared Lantzy, Center for practices regulation (21 CFR 10.115).
AGENCY: Food and Drug Administration, Drug Evaluation and Research, Food The guidance represents FDA’s current
HHS. and Drug Administration, 10903 New thinking on this topic. It does not create
ACTION: Notice. Hampshire Ave., Bldg. 22, Rm. 1116, or confer any rights for or on any person
Silver Spring, MD 20993, email: esub@ and does not operate to bind FDA or the
SUMMARY: The Food and Drug fda.hhs.gov. public. An alternative approach may be
Administration (FDA) is announcing the used if such approach satisfies the
SUPPLEMENTARY INFORMATION:
availability of a document entitled requirements of the applicable statutes
‘‘Electronic Submission of Lot I. Background and regulations.
Distribution Reports; Guidance for FDA is announcing the availability of
Industry.’’ The guidance document a document entitled ‘‘Electronic II. Paperwork Reduction Act of 1995
provides information and Submission of Lot Distribution Reports;
recommendations pertaining to the This guidance refers to previously
Guidance for Industry.’’ The guidance approved collections of information
electronic submission of lot distribution provides information and
reports for applicants with approved found in FDA regulations. These
recommendations pertaining to the collections of information are subject to
biologics license applications (BLAs). electronic submission of lot distribution
FDA recently published in the Federal review by the Office of Management and
reports. The guidance provides
Register a final rule requiring that, Budget (OMB) under the Paperwork
information on how to electronically
among other things, lot distribution Reduction Act of 1995 (44 U.S.C. 3501–
submit lot distribution reports for
reports be submitted to FDA in an biological products under approved 3520). The collections of information in
electronic format that the Agency can BLAs for which CBER or CDER has 21 CFR 600.81 and 600.90 have been
process, review, and archive. The regulatory responsibility. The guidance approved under 0910–0308.
guidance announced in this notice does not apply to any other biological
finalizes the draft guidance entitled III. Comments
product.
‘‘Guidance for Industry: Electronic FDA published in the Federal Interested persons may submit either
Submission of Lot Distribution Reports’’ Register of June 10, 2014 (79 FR 33072), electronic comments regarding this
dated August 2014, and is intended to a final rule requiring electronic document to http://www.regulations.gov
help licensed manufacturers of products submission of certain postmarketing or written comments to the Division of
distributed under an approved BLA submissions. Among other things, under Dockets Management (see ADDRESSES). It
(henceforth referred to as applicants) this rule applicants are required to
comply with the final rule. is only necessary to send one set of
submit biological lot distribution reports comments. Identify comments with the
DATES: Submit either electronic or to FDA in an electronic format that the docket number found in brackets in the
written comments on Agency guidances Agency can process, review, and heading of this document. Received
at any time. archive. The guidance is intended to comments may be seen in the Division
ADDRESSES: Submit written requests for help applicants subject to lot of Dockets Management between 9 a.m.
single copies of the guidance to the distribution reporting comply with the and 4 p.m., Monday through Friday, and
Office of Communication, Outreach and final rule. Along with other information, will be posted to the docket at http://
Development, Center for Biologics the guidance provides updated
www.regulations.gov.
Evaluation and Research (CBER), Food information about the following: (1)
and Drug Administration, 10903 New Structured Product Labeling standard IV. Electronic Access
Hampshire Ave., Bldg. 71, Rm. 3128, and vocabulary for electronic
Silver Spring, MD 20993–0002 or submission of lot distribution reporting; Persons with access to the Internet
Division of Drug Information, Center for (2) additional resources such as may obtain the guidance at either http://
Drug Evaluation and Research (CDER), implementation guide, validation www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
mstockstill on DSK4VPTVN1PROD with NOTICES
Food and Drug Administration, 10903 procedures and links with further
New Hampshire Ave., Bldg. 51, Rm. information; and (3) procedures for RegulatoryInformation/Guidances/
2201, Silver Spring, MD 20993–0002. requesting temporary waivers from the default.htm, http://www.fda.gov/Drugs/
Send one self-addressed adhesive label electronic submission requirement. GuidanceCompliance
to assist the office in processing your In the Federal Register of August 29, RegulatoryInformation/Guidances/
requests. The guidance may also be 2014 (79 FR 51576), FDA announced the default.htm, or http://
obtained by mail by calling CBER at 1– availability of the draft guidance www.regulations.gov.
800–835–4709 or 240–402–7800. See entitled ’’ Guidance for Industry:
VerDate Sep<11>2014 16:51 Mar 20, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1](https://thefederalregister.org/doc/80_FR_15272/page/1.svg)
![15218 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Dated: March 17, 2015. letter, which finds Licensee’s kit to be a Freedom of Information Act, 5 U.S.C.
Leslie Kux, medical device substantially equivalent to 552.
Associate Commissioner for Policy. one or more similar legally marketed devices,
and states that the Licensee’s device can be Dated: March 17, 2015.
[FR Doc. 2015–06498 Filed 3–20–15; 8:45 am] marketed in the U.S. (i.e., 510(k) cleared), Richard U. Rodriguez,
BILLING CODE 4164–01–P such test kit to be distributed in commerce Acting Director, Office of Technology
for the purpose of predicting survival, Transfer, National Institutes of Health.
response to therapy, or cancer recurrence in [FR Doc. 2015–06487 Filed 3–20–15; 8:45 am]
DEPARTMENT OF HEALTH AND breast cancer patients.’’
BILLING CODE 4140–01–P
HUMAN SERVICES Upon the expiration or termination of
National Institutes of Health the exclusive evaluation option license,
ProVivoX, Inc., will have the exclusive DEPARTMENT OF HEALTH AND
Prospective Grant of Exclusive right to execute an exclusive HUMAN SERVICES
License: The Development of commercialization license which will
supersede and replace the exclusive National Institutes of Health
Theranostic Kits for mTOR Analog-
based Chemotherapy evaluation option license with no Submission for OMB Review; 30-Day
greater field of use and territory than Comment Request Prevalence,
AGENCY: National Institutes of Health, granted in the exclusive evaluation
HHS. Incidence, Epidemiology and
option license. Molecular Variants of HIV in Blood
ACTION: Notice.
DATES: Only written comments or Donors in Brazil (NHLBI)
SUMMARY: This is notice, in accordance applications for a license (or both)
which are received by the NIH Office of SUMMARY: Under the provisions of
with 35 U.S.C. 209 and 37 CFR part 404,
Technology Transfer on or before April Section 3507(a)(1)(D) of the Paperwork
that the National Institutes of Health,
7, 2015 will be considered. Reduction Act of 1995, the National
Department of Health and Human
Heart, Lung, and Blood Institute
Services, is contemplating the grant to ADDRESSES: Requests for copies of the
(NHLBI), the National Institutes of
ProVivoX, Inc., of an exclusive patent application, inquiries, comments,
Health (NIH) has submitted to the Office
evaluation option license to practice the and other materials relating to the of Management and Budget (OMB) a
inventions embodied in the following contemplated exclusive evaluation request for review and approval of the
US Patent, US Patent Application, and option license should be directed to: information collection listed below.
International Patent Application (and all Patrick McCue, Ph.D., Licensing and This proposed information collection
foreign counterparts): US Provisional Patenting Manager, Office of was previously published in the FR in
Patent Application Serial No. 61/ Technology Transfer, National Institutes Volume 79 on December 31, 2014 on
144,501, filed 14 January 2009, entitled: of Health, 6011 Executive Boulevard, page 78876 and allowed 60-days for
‘‘Ratio-based Biomarker of Survival Suite 325, Rockville, MD 20852–3804; public comment. One public comment
Utilizing PTEN and Phospho-AKT’’ Telephone: (301) 435–5560; Facsimile: was received that was a personal
[HHS Reference No. E–025–2009/0–US– (301) 402–0220; Email: mccuepat@ opinion regarding conducting research
01]; International Application No. PCT/ mail.nih.gov. about the Brazil blood donation system.
US2010/020944, filed on 13 January SUPPLEMENTARY INFORMATION: The The purpose of this notice is to allow an
2010, entitled: ‘‘Ratio-based Biomarkers technology describes a method of additional 30 days for public comment.
and Methods of Use Thereof’’ [HHS identifying cancer patients that may The National Institutes of Health may
Reference No. E–025–2009/0–PCT–02]; benefit from mTOR analog-based not conduct or sponsor, and the
US Patent Application Serial No. 13/ chemotherapy or agents directed against respondent is not required to respond
144,474, filed 13 July 2011 [HHS the AKT pathway. to, an information collection that has
Reference No. E–025–2009/0–US–02]; The prospective exclusive evaluation been extended, revised, or implemented
and Canadian Patent Application No. license is being considered under the on or after October 1, 1995, unless it
2,749,601, filed on 13 January 2010 small business initiative launched on 1 displays a currently valid OMB control
[HHS Reference No. E–025–2009/0–CA– October 2011, and will comply with the number.
05]. The patent rights in this invention terms and conditions of 35 U.S.C. 209 Direct Comments To Omb: Written
have been assigned to the Government and 37 CFR part 404. The prospective comments and/or suggestions regarding
of the United States of America. exclusive evaluation option license, and the item(s) contained in this notice,
The prospective exclusive evaluation especially regarding the estimated
a subsequent exclusive
option license territory may be United public burden and associated response
commercialization license, may be
States and Canada, and the field of use time, should be directed to the: Office
granted unless the NIH receives written
may be limited to: of Management and Budget, Office of
evidence and argument that establishes
a. ‘‘Exclusive use of the Licensed Patent that the grant of the license would not Regulatory Affairs, OIRA_submission@
Rights to develop an immunohistochemistry be consistent with the requirements of omb.eop.gov or by fax to 202–395–6974,
(IHC)- or tissue microarray-based test kit for Attention: Desk Officer for NIH.
use with human tissue samples and approved
35 U.S.C. 209 and 37 CFR part 404
in the United States and Canada as a Class within fifteen (15) days from the date of Comments Due Date: Comments
III medical device, such test kit to be this published notice. regarding this information collection are
distributed in commerce for the for the Complete applications for a license in best assured of having their full effect if
received within 30 days of the date of
mstockstill on DSK4VPTVN1PROD with NOTICES
purpose of predicting survival, response to the field of use filed in response to this
therapy, or cancer recurrence in breast cancer notice will be treated as objections to this publication.
patients.’’ the grant of the contemplated exclusive FOR FURTHER INFORMATION CONTACT: To
b. ‘‘Non-exclusive use of the Licensed evaluation option license. Comments obtain a copy of the data collection
Patent Rights to develop an
immunohistochemistry (IHC)- or tissue and objections submitted to this notice plans and instruments or request more
microarray-based test kit for use with human will not be made available for public information on the proposed project
tissue samples and for which the United inspection and, to the extent permitted contact: Simone Glynn, MD, Project
States FDA issues an order, in the form of a by law, will not be released under the Officer/ICD Contact, Two Rockledge
VerDate Sep<11>2014 16:51 Mar 20, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1](https://thefederalregister.org/doc/80_FR_15272/page/2.svg)
Document Created: 2018-02-21 09:47:35
Document Modified: 2018-02-21 09:47:35
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Lori J. Churchyard, 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; or Jared Lantzy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1116, Silver Spring, MD 20993, email: [email protected] | |
| FR Citation | 80 FR 15217 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR