80 FR 15214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
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 | 15214-15217 | |
| FR Document | 2015-06497 |
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)] [Notices] [Pages 15214-15217] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06497] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0742] Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirements for drug establishment registration and drug listing. DATES: Submit either electronic or written comments on the collection of information by May 22, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002; [email protected]. SUPPLEMENTARY INFORMATION: Under 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, including each proposed extension of an existing 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 following collection of information, 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. Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution--21 CFR Part 207 (OMB Control Number 0910-0045)--Extension Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health Service Act (42 U.S.C. [[Page 15215]] 262), and part 207 (21 CFR part 207). Fundamental to FDA's mission to protect the public health is the collection of this information, which is used for important activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the United States. Comprehensive, accurate, and up to date information is critical to conducting these activities with efficiency and effectiveness. Under section 510 of the FD&C Act, FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution. To implement section 510 of the FD&C Act, FDA issued part 207. Under current Sec. 207.20, manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishment. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Owners or operators of establishments that distribute under their own label or trade name a drug product manufactured by a registered establishment are not required either to register or list. However, distributors may elect to submit drug listing information in lieu of the registered establishment that manufactures the drug product. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States. Under current Sec. 207.21, establishments, both domestic and foreign, must register with FDA within 5 days after beginning the manufacture of drugs or biologicals, or within 5 days after the submission of a drug application or biological license application. In addition, establishments must register annually. Changes in individual ownership, corporate or partnership structure, location, or drug handling activity must be submitted as amendments to registration under current Sec. 207.26 within 5 days of such changes. Under Sec. 207.20(b), private label distributors may request their own labeler code and elect to submit drug listing information to FDA. In such instances, at the time of submitting or updating drug listing information, private label distributors must certify to the registered establishment that manufactured, prepared, propagated, compounded, or processed (which includes, among other things, repackaging and relabeling) the listed drug that the drug listing submission was made. Establishments must, within 5 days of beginning the manufacture of drugs or biologicals, submit to FDA a listing for every drug or biological product in commercial distribution at that time. Private label distributors may elect to submit to FDA a listing of every drug product they place in commercial distribution. Registered establishments must submit to FDA drug product listing for those private label distributors who do not elect to submit listing information. Under Sec. 207.25, product listing information submitted to FDA by domestic and foreign manufacturers must, depending on the type of product being listed, include any new drug application number or biological establishment license number, copies of current labeling and a sampling of advertisements, a quantitative listing of the active ingredient for each drug or biological product not subject to an approved application or license, the NDC number, and any drug imprinting information. In addition to the product listing information required, FDA may also require, under Sec. 207.31, a copy of all advertisements and a quantitative listing of all ingredients for each listed drug or biological product not subject to an approved application or license; the basis for a determination, by the establishment, that a listed drug or biological product is not subject to marketing or licensing approval requirements; and a list of certain drugs or biological products containing a particular ingredient. FDA may also request, but not require, the submission of a qualitative listing of the inactive ingredients for all listed drugs or biological products, and a quantitative listing of the active ingredients for all listed drugs or biological products subject to an approved application or license. Under Sec. 207.30, establishments must update their product listing information every June and December or, at the discretion of the establishment, when any change occurs. These updates must include the following information: (1) A listing of all drug or biological products introduced for commercial distribution that have not been included in any previously submitted list; (2) all drug or biological products formerly listed for which commercial distribution has been discontinued; (3) all drug or biological products for which a notice of discontinuance was submitted and for which commercial distribution has been resumed; and (4) any material change in any information previously submitted. No update is required if no changes have occurred since the previously submitted list. Historically, drug establishment registration and drug listing information have been submitted in paper form using Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors) (collectively referred to as FDA Forms). Changes in the FD&C Act resulting from enactment of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) (FDAAA) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Before the enactment of FDAAA, section 510(p) of the FD&C Act expressly provided for electronic submission of drug establishment registration information upon a finding that electronic receipt was feasible, and section 510(j) of the FD&C Act provided that drug listing information be submitted in the form and manner prescribed by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C Act, now expressly, requires electronic drug listing in addition to drug establishment registration. In certain cases, if it is unreasonable to expect a person to submit registration and listing information electronically, FDA may grant a waiver from the electronic format requirement. In the Federal Register of June 1, 2009 (74 FR 26248), FDA announced the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing'' (the 2009 guidance). The document provides guidance to industry on the statutory requirement to submit electronically drug establishment registration and drug listing information. The guidance describes the types of information to include for purposes of drug establishment registration and drug listing and how to prepare and submit the information in an electronic format (Structured Product Labeling (SPL) files) that FDA can process, review, and archive. In addition to the information that previously was collected on the FDA Forms, the guidance addresses [[Page 15216]] electronic submission of other required information as follows:For registered foreign drug establishments, the name, address, and telephone number of its U.S. agent (Sec. 207.40(c)); the name of each importer that is known to the establishment (the U.S. company or individual in the United States that is an owner, consignee, or recipient of the foreign establishment's drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or the patient) (section 510(i)(1)(A) of the FD&C Act); and the name of each person who imports or offers for import (the name of each agent, broker, or other entity, other than a carrier, that the foreign drug establishment uses to facilitate the import of their drug into the United States) (section 510(i)(1)(A) of the FD&C Act). FDA also recommends the voluntary submission of the following additional information, when applicable: To facilitate correspondence between foreign establishments and FDA, the email address for the U.S. agent, and the telephone number(s) and email address for the importer and person who imports or offers for import their drug; a site-specific Data Universal Numbering System number for each entity (e.g., the registrant, establishments, U.S. agent, importer); the NDC product code for the source drug that is repacked or relabeled; distinctive characteristics of certain listed drugs, i.e., the flavor, the color, and image of the actual solid dosage form; and registrants may indicate that they view as confidential the registrant's business relationship with an establishment, or an inactive ingredient. In addition to this collection of information, there is an additional burden for the following activities: preparing a standard operating procedure (SOP) for the electronic submission of drug establishment registration and drug listing information; creating the SPL file, including accessing and reviewing the technical specifications and instructional documents provided by FDA (accessible at http://www.fda.gov/oc/datacouncil/spl.html); reviewing and selecting appropriate terms and codes used to create the SPL file (accessible at http://www.fda.gov/oc/datacouncil/spl.html); obtaining the digital certificate used with FDA's electronic submission gateway and uploading the SPL file for submission (accessible at http://www.fda.gov/esg/default.htm); and requests for waivers from the electronic submission process as described in the draft guidance. When FDA published the 2009 guidance on submitting establishment registration and drug listing information in electronic format, the Agency also amended its burden estimates for OMB control number 0910- 0045 to include the additional burden for the collection of information that had not been submitted using the FDA forms, and to create and upload the SPL file. The amended burden estimates included the one-time preparation of an SOP for creating and uploading the SPL file. Although most firms will already have prepared an SOP for the electronic submission of drug establishment registration and drug listing information, each year additional firms will need to create an SOP. As provided in Table 2 of this document, FDA estimates that approximately 1,000 firms will have to expend a one-time burden to prepare, review, and approve an SOP, and the Agency estimates that it will take 40 hours per recordkeeper to create 1,000 new SOPs for a total of 40,000 hours. In Tables 1 and 2, the information collection requirements of the drug establishment registration and drug listing requirements have been grouped according to the information collection areas of the requirements. Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- New registrations, including new 1,400 2 2,800 4.5 12,600 labeler codes requests......... Annual updates of registration 10,000 1 10,000 4.5 45,000 information.................... New drug listings............... 1,567 7 11,000 4.5 49,500 New listings for private label 146 10.06 1,469 4.5 6,611 distributor.................... June and December updates of all 5,300 20 106,000 4.5 477,000 drug listing information....... Waiver requests................. 1 1 1 1 1 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 590,712 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Activity resulting from section Number of Average 510(p) of the FD&C Act as Number of records per Total annual burden per Total hours amended by FDAAA recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- One-time preparation of SOP..... 1,000 1 1,000 40 40,000 SOP maintenance................. 3,295 1 3,295 1 3,295 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 43,295 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with the collection of information. [[Page 15217]] Dated: March 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06497 Filed 3-20-15; 8:45 am] BILLING CODE 4164-01-P
![15214 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
delivery. The Patient Safety Rule Services Group was delisted effective at information to the Division of Dockets
authorizes AHRQ, on behalf of the 12:00 Midnight ET (2400) on January 5, Management (HFA 305), Food and Drug
Secretary of HHS, to list as a PSO an 2015. Administration, 5630 Fishers Lane, Rm.
entity that attests that it meets the PSO Services Group has patient safety 1061, Rockville, MD 20852. All
statutory and regulatory requirements work product (PSWP) in its possession. comments should be identified with the
for listing. A PSO can be ‘‘delisted’’ by The PSO will meet the requirements of docket number found in brackets in the
the Secretary if it is found to no longer section 3.108(c)(2)(i) of the Patient heading of this document.
meet the requirements of the Patient Safety Rule regarding notification to FOR FURTHER INFORMATION CONTACT: FDA
Safety Act and Patient Safety Rule, providers that have reported to the PSO. PRA Staff, Office of Operations, Food
when a PSO chooses to voluntarily In addition, according to sections and Drug Administration, 8455
relinquish its status as a PSO for any 3.108(c)(2)(ii) and 3.108(b)(3) of the Colesville Rd., COLE–14526, Silver
reason, or when a PSO’s listing expires. Patient Safety Rule regarding Spring, MD 20993–0002; PRAStaff@
AHRQ has accepted a notification of disposition of PSWP, the PSO has 90 fda.hhs.gov.
voluntary relinquishment from PSO days from the effective date of delisting
SUPPLEMENTARY INFORMATION: Under the
Services Group of its status as a PSO, and revocation to complete the
and has delisted the PSO accordingly. PRA (44 U.S.C. 3501–3520), Federal
disposition of PSWP that is currently in
Agencies must obtain approval from the
DATES: The directories for both listed the PSO’s possession.
Office of Management and Budget
and delisted PSOs are ongoing and More information on PSOs can be
(OMB) for each collection of
reviewed weekly by AHRQ. The obtained through AHRQ’s PSO Web site
information they conduct or sponsor.
delisting was effective at 12:00 Midnight at http://www.pso.AHRQ.gov/
‘‘Collection of information’’ is defined
ET (2400) on January 5, 2015. index.html.
in 44 U.S.C. 3502(3) and 5 CFR
ADDRESSES: Both directories can be Dated: March 17, 2015. 1320.3(c) and includes Agency requests
accessed electronically at the following Sharon B. Arnold, or requirements that members of the
HHS Web site: http:// Deputy Director, AHRQ. public submit reports, keep records, or
www.pso.AHRQ.gov/index.html. [FR Doc. 2015–06455 Filed 3–20–15; 8:45 am] provide information to a third party.
FOR FURTHER INFORMATION CONTACT: BILLING CODE 4160–90–P Section 3506(c)(2)(A) of the PRA (44
Eileen Hogan, Center for Quality U.S.C. 3506(c)(2)(A)) requires Federal
Improvement and Patient Safety, AHRQ, Agencies to provide a 60-day notice in
540 Gaither Road, Rockville, MD 20850; DEPARTMENT OF HEALTH AND the Federal Register concerning each
Telephone (toll free): (866) 403–3697; HUMAN SERVICES proposed collection of information,
Telephone (local): (301) 427–1111; TTY including each proposed extension of an
(toll free): (866) 438–7231; TTY (local): Food and Drug Administration existing collection of information,
(301) 427–1130; Email: PSO@ [Docket No. FDA–2011–N–0742] before submitting the collection to OMB
AHRQ.hhs.gov. for approval. To comply with this
SUPPLEMENTARY INFORMATION: Agency Information Collection requirement, FDA is publishing notice
Activities; Proposed Collection; of the proposed collection of
Background Comment Request; Registration of information set forth in this document.
The Patient Safety Act authorizes the Producers of Drugs and Listing of With respect to the following
listing of PSOs, which are entities or Drugs in Commercial Distribution collection of information, FDA invites
component organizations whose comments on these topics: (1) Whether
mission and primary activity are to AGENCY: Food and Drug Administration, the proposed collection of information
conduct activities to improve patient HHS. is necessary for the proper performance
safety and the quality of health care ACTION: Notice. of FDA’s functions, including whether
delivery. the information will have practical
HHS issued the Patient Safety Rule to SUMMARY: The Food and Drug
utility; (2) the accuracy of FDA’s
implement the Patient Safety Act. Administration (FDA) is announcing an
estimate of the burden of the proposed
AHRQ administers the provisions of the opportunity for public comment on the
collection of information, including the
Patient Safety Act and Patient Safety proposed collection of certain
validity of the methodology and
Rule relating to the listing and operation information by the Agency. Under the
assumptions used; (3) ways to enhance
of PSOs. The Patient Safety Rule Paperwork Reduction Act of 1995 (the
the quality, utility, and clarity of the
authorizes AHRQ to list as a PSO an PRA), Federal Agencies are required to
information to be collected; and (4)
entity that attests that it meets the publish notice in the Federal Register
ways to minimize the burden of the
statutory and regulatory requirements concerning each proposed collection of
collection of information on
for listing. A PSO can be ‘‘delisted’’ if information, including each proposed
respondents, including through the use
it is found to no longer meet the extension of an existing collection of
of automated collection techniques,
requirements of the Patient Safety Act information, and to allow 60 days for
when appropriate, and other forms of
and Patient Safety Rule, when a PSO public comment in response to the
information technology.
chooses to voluntarily relinquish its notice. This notice solicits comments on
status as a PSO for any reason, or when the requirements for drug establishment Registration of Producers of Drugs and
a PSO’s listing expires. Section 3.108(d) registration and drug listing. Listing of Drugs in Commercial
DATES: Submit either electronic or Distribution—21 CFR Part 207 (OMB
mstockstill on DSK4VPTVN1PROD with NOTICES
of the Patient Safety Rule requires
AHRQ to provide public notice when it written comments on the collection of Control Number 0910–0045)—Extension
removes an organization from the list of information by May 22, 2015. Requirements for drug establishment
federally approved PSOs. ADDRESSES: Submit electronic registration and drug listing are set forth
AHRQ has accepted a notification comments on the collection of in section 510 of the Federal Food,
from PSO Services Group, PSO number information to http:// Drug, and Cosmetic Act (the FD&C Act)
P0028, to voluntarily relinquish its www.regulations.gov. Submit written (21 U.S.C. 360), section 351 of the
status as a PSO. Accordingly, PSO comments on the collection of Public Health Service Act (42 U.S.C.
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![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:
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Document Created: 2018-02-21 09:47:25
Document Modified: 2018-02-21 09:47:25
| 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 the collection of information by May 22, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002; [email protected] | |
| FR Citation | 80 FR 15214 |
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