Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 17484-17487 [2012-7136]
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17484
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
to seek reclassification from a lower to
a higher class, thereby increasing the
regulatory requirements applicable to
that device type. If approved, petitions
requesting classification from class III to
class II or class I provide an alternative
route to market in lieu of premarket
approval for class III devices. If
approved, petitions requesting
reclassification from class I or II, to a
different class, may increase
requirements.
In the Federal Register of November
14, 2011 (76 FR 70460), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
860.123 ................................................................................
6
1
6
500
3,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff who: (1) Are familiar
with the requirements for submission of
a reclassification petition, (2) have
consulted and advised manufacturers on
these requirements, and (3) have
reviewed the documentation submitted.
Dated: March 20, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–7142 Filed 3–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 25,
2012.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
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; 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-todate information is critical to
conducting these activities with
efficiency and effectiveness.
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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 207.1
Under current § 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
1 This document addresses the information
collection in current part 207. In the Federal
Register of August 29, 2006 (the 2006 proposed
rule) (71 FR 51276), FDA proposed to revise part
207. The proposed revisions would reorganize,
consolidate, clarify, and modify current regulations
concerning who must register establishments and
list, and describes when and how to register and list
and what information must be submitted for
registration and listing. In addition, the proposal
would make certain changes to the National Drug
Code (NDC) system and would require the
appropriate NDC number to appear on the labels for
drugs subject to the listing requirements. The
proposed regulations generally also require the
electronic submission of all registration and most
listing information. The 2006 proposed rule
requested comments on the information collection
for revised part 207. When the proposal is finalized,
the information collection for a revised part 207
will replace the information collection in this
document.
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Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
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 § 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 (BLA). 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 § 207.26
within 5 days of such changes. Under
§ 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 § 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 (NDA) 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 § 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
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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 § 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
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17485
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 by the FDA
Forms, the guidance addresses
electronic submission of other required
information as follows:
• For registered foreign drug
establishments, the name, address, and
telephone number of its U.S. agent
(§ 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 (DUNS) 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;
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Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
• 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 the collection of
information, there is 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 https://www.fda.gov/oc/datacouncil/
spl.html);
• Reviewing and selecting
appropriate terms and codes used to
create the SPL file (accessible at
https://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 https://
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 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. The information
collection requirements of the Drug
Listing and Establishment Registration
regulations have been grouped
according to the information collection
areas of the regulations.
In the Federal Register of October 24,
2011 (76 FR 65730), FDA published a
60-day notice requesting public
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comment on the proposed collection of
information. FDA received one
comment.
Comment
The comment raised two issues and
asked for several procedural
clarifications. The first issue raised
suggested that the burden to industry
might be greater than the 4.5-hour
average provided in the estimate. The
next issue questioned the process by
which FDA issued a guidance to address
the electronic submissions process
without changing the regulation that
still describes a paper submission
process, which would have allowed for
public comment on that change. The
comment then sought several
procedural clarifications on: (1) How to
submit changes in ownership of an
establishment, (2) how to select a
business function, (3) how to ensure
that an establishment is represented
consistently between a vendor’s
registration and the client’s drug
establishment registration, (4) how to
link an importer with a particular
product, (5) how to list bulk tablets that
will be imported for packaging, and (6)
how to certify to the registered
establishment that the private label
distributor has listed the product.
Response
FDA acknowledges that the 2009
guidance is different from the process
described in the current part 207. As
was stated in the Federal Register
notice and as acknowledged by the
commenter, the current regulation
predates the electronic process and
describes a paper-based submission
process. FDA is in the process of
rewriting part 207, and published the
draft version for public comment in
2006. Afterward, the FDAAA mandated
the electronic submission of drug
establishment and drug product
information. The 2009 guidance was
created to address the mandate of
FDAAA. The 2006 proposed rule will be
modified appropriately to address the
FDAAA mandates as well. With regards
to the estimated burden, FDA
collaborated with members of industry
and international health information
data standards organizations to arrive at
the current process and estimates for the
burden of gathering, assembling, and
submitting data. The estimates are
considered to be averages that will vary
up or down per individual respondent.
The following paragraphs are
intended to clarify one of the
commenter’s issues mentioned
previously in this document:
1. Changes to the establishment name,
registrant name, or other registration
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information can be made by submitting
an updated registration submission via
SPL. Changes in corporate ownership or
officers that do not affect names,
addresses, or the DUNS number(s) for a
registered establishment should be
made with Dun and Bradstreet. That
data is then referenced as needed by
FDA using the DUNS number.
Information about submitting SPL can
be found at the link at the end of the
FDA response. It should be noted that
changes in ownership may also require
the submission of updates to listing
information, labeler code name and
DUNS, and application data for NDAs,
abbreviated new drug applications
(ANDAs), BLAs, new animal drug
applications (NADAs), and abbreviated
new animal drug applications
(ANADAs).
2. For selecting a business operation,
a current list of valid business functions
and their associated codes can be found
at the link at the end of this response.
Please note that if more than one
business function apply, a registrant
should select all that apply and include
them in the registration SPL.
3. FDA has implemented an
automated validation of all drug product
listing submissions to ensure that each
establishment referenced in the product
listing is registered under the same
business operation. For example, a
product listing SPL that references a
particular facility as a packer of the
product will be rejected if that
establishment has not chosen Pack as a
business operation in its registration.
FDA expects vendors and clients to
communicate this information directly
to each other and, if necessary,
coordinate their submissions in order to
avoid issues with this validation.
4. The importer information is
submitted via the registration of the
foreign establishment. Any product
listing referencing that foreign
establishment should therefore provide
the necessary link from importer to
product. Information about submitting
SPL can be found at the link at the end
of the FDA response.
5. A product listing for bulk tablets
intended for further processing or
packaging should be listed using the
SPL product/document type of Bulk
Ingredient and a marketing category of
Drug for Further Processing. Information
about submitting SPL can be found at
the link at the end of the FDA response.
6. For finished dosage forms,
appearance in the NDC Directory is
proof of submission of listing. Note that
unfinished products and active
pharmaceutical ingredient listings will
not appear in the NDC Directory.
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Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
Instructions and SPL resources may
be found on the SPL Resources Web
page at https://www.fda.gov/ForIndustry/
DataStandards/
StructuredProductLabeling/default.htm
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
New registrations, including new labeler codes requests ...
Annual updates of registration information ..........................
New drug listings .................................................................
New listings for private label distributor ...............................
June and December updates of all drug listing information
Waiver requests ...................................................................
39
3,256
1,567
146
1,677
1
14.72
2.99
6.57
10.06
11.21
1
574
9,735
10,295
1,469
18,799
1
4.5
4.5
4.5
4.5
4.5
1
2,583
43,808
46,328
6,611
84,596
1
Total ..............................................................................
........................
........................
........................
........................
183,927
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 510(p) of the FD&C Act as
amended by FDAAA
Number of
recordkeepers
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
One-time preparation of SOP ..............................................
SOP maintenance ................................................................
1,000
3,295
1
1
1,000
3,295
40
1
40,000
3,295
Total ..............................................................................
........................
........................
........................
........................
43,295
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 20, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–7136 Filed 3–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Antiviral Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Antiviral Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 11, 2012, from 8 a.m. to 5
p.m.
Location: DoubleTree by Hilton Hotel
Washington DC/Silver Spring, The
Ballrooms, 8727 Colesville Rd., Silver
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Spring, MD. The hotel telephone
number is 301–589–5200.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
AVAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
new drug application (NDA) 203–100,
for a fixed-dose combination tablet of
elvitegravir/cobicistat/emtricitabine/
tenofovir disoproxil fumarate, submitted
by Gilead Sciences, Inc. The application
proposes an indication for the treatment
of HIV–1 infection in adults who are
¨
antiretroviral naıve or have no known
substitutions associated with resistance
to the individual components.
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FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/default.
htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 27, 2012. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 19,
2012. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
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]]>Agencies
[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17484-17487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7136]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0742]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
25, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0045.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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; 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.\1\ 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
[[Page 17485]]
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.
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\1\ This document addresses the information collection in
current part 207. In the Federal Register of August 29, 2006 (the
2006 proposed rule) (71 FR 51276), FDA proposed to revise part 207.
The proposed revisions would reorganize, consolidate, clarify, and
modify current regulations concerning who must register
establishments and list, and describes when and how to register and
list and what information must be submitted for registration and
listing. In addition, the proposal would make certain changes to the
National Drug Code (NDC) system and would require the appropriate
NDC number to appear on the labels for drugs subject to the listing
requirements. The proposed regulations generally also require the
electronic submission of all registration and most listing
information. The 2006 proposed rule requested comments on the
information collection for revised part 207. When the proposal is
finalized, the information collection for a revised part 207 will
replace the information collection in this document.
---------------------------------------------------------------------------
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
(BLA). 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 (NDA) 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 by the
FDA Forms, the guidance addresses 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 (DUNS)
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;
[[Page 17486]]
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 the collection of information, there is 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 https://www.fda.gov/oc/datacouncil/spl.html);
Reviewing and selecting appropriate terms and codes used
to create the SPL file (accessible at https://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 https://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 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.
The information collection requirements of the Drug Listing and
Establishment Registration regulations have been grouped according to
the information collection areas of the regulations.
In the Federal Register of October 24, 2011 (76 FR 65730), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
Comment
The comment raised two issues and asked for several procedural
clarifications. The first issue raised suggested that the burden to
industry might be greater than the 4.5-hour average provided in the
estimate. The next issue questioned the process by which FDA issued a
guidance to address the electronic submissions process without changing
the regulation that still describes a paper submission process, which
would have allowed for public comment on that change. The comment then
sought several procedural clarifications on: (1) How to submit changes
in ownership of an establishment, (2) how to select a business
function, (3) how to ensure that an establishment is represented
consistently between a vendor's registration and the client's drug
establishment registration, (4) how to link an importer with a
particular product, (5) how to list bulk tablets that will be imported
for packaging, and (6) how to certify to the registered establishment
that the private label distributor has listed the product.
Response
FDA acknowledges that the 2009 guidance is different from the
process described in the current part 207. As was stated in the Federal
Register notice and as acknowledged by the commenter, the current
regulation predates the electronic process and describes a paper-based
submission process. FDA is in the process of rewriting part 207, and
published the draft version for public comment in 2006. Afterward, the
FDAAA mandated the electronic submission of drug establishment and drug
product information. The 2009 guidance was created to address the
mandate of FDAAA. The 2006 proposed rule will be modified appropriately
to address the FDAAA mandates as well. With regards to the estimated
burden, FDA collaborated with members of industry and international
health information data standards organizations to arrive at the
current process and estimates for the burden of gathering, assembling,
and submitting data. The estimates are considered to be averages that
will vary up or down per individual respondent.
The following paragraphs are intended to clarify one of the
commenter's issues mentioned previously in this document:
1. Changes to the establishment name, registrant name, or other
registration information can be made by submitting an updated
registration submission via SPL. Changes in corporate ownership or
officers that do not affect names, addresses, or the DUNS number(s) for
a registered establishment should be made with Dun and Bradstreet. That
data is then referenced as needed by FDA using the DUNS number.
Information about submitting SPL can be found at the link at the end of
the FDA response. It should be noted that changes in ownership may also
require the submission of updates to listing information, labeler code
name and DUNS, and application data for NDAs, abbreviated new drug
applications (ANDAs), BLAs, new animal drug applications (NADAs), and
abbreviated new animal drug applications (ANADAs).
2. For selecting a business operation, a current list of valid
business functions and their associated codes can be found at the link
at the end of this response. Please note that if more than one business
function apply, a registrant should select all that apply and include
them in the registration SPL.
3. FDA has implemented an automated validation of all drug product
listing submissions to ensure that each establishment referenced in the
product listing is registered under the same business operation. For
example, a product listing SPL that references a particular facility as
a packer of the product will be rejected if that establishment has not
chosen Pack as a business operation in its registration. FDA expects
vendors and clients to communicate this information directly to each
other and, if necessary, coordinate their submissions in order to avoid
issues with this validation.
4. The importer information is submitted via the registration of
the foreign establishment. Any product listing referencing that foreign
establishment should therefore provide the necessary link from importer
to product. Information about submitting SPL can be found at the link
at the end of the FDA response.
5. A product listing for bulk tablets intended for further
processing or packaging should be listed using the SPL product/document
type of Bulk Ingredient and a marketing category of Drug for Further
Processing. Information about submitting SPL can be found at the link
at the end of the FDA response.
6. For finished dosage forms, appearance in the NDC Directory is
proof of submission of listing. Note that unfinished products and
active pharmaceutical ingredient listings will not appear in the NDC
Directory.
[[Page 17487]]
Instructions and SPL resources may be found on the SPL Resources
Web page at https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
FDA estimates the burden of this collection of information as
follows:
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 39 14.72 574 4.5 2,583
labeler codes requests.........
Annual updates of registration 3,256 2.99 9,735 4.5 43,808
information....................
New drug listings............... 1,567 6.57 10,295 4.5 46,328
New listings for private label 146 10.06 1,469 4.5 6,611
distributor....................
June and December updates of all 1,677 11.21 18,799 4.5 84,596
drug listing information.......
Waiver requests................. 1 1 1 1 1
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Total....................... .............. .............. .............. .............. 183,927
----------------------------------------------------------------------------------------------------------------
\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 burden
510(p) of the FD&C Act as Number of records per Total annual 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
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Total....................... .............. .............. .............. .............. 43,295
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 20, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7136 Filed 3-23-12; 8:45 am]
BILLING CODE 4160-01-P
