Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability, 39964-39968 [E8-15801]
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Federal Register / Vol. 73, No. 134 / Friday, July 11, 2008 / Notices
Respondents: Executive directors and
key staff of faith based and community
organizations that received three-year
CEY grants beginning in 2007.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Lead Organization Executive Director .............................................................
Lead Organization Key Staff ...........................................................................
Partner Organization Executive Director .........................................................
Partner Organization Key Staff ........................................................................
Estimated Total Annual Burden
Hours: 445.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
OPREInfoCollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, FAX: 202–395–6974,
Attn: Desk Officer for ACF.
Dated: July 2, 2008.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E8–15502 Filed 7–10–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
pwalker on PROD1PC71 with NOTICES
[Docket No. FDA–2006–N–0364] (formerly
Docket Nos. 2006N–0466 and FDA–2007–
0650)
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–710), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–796–
3794.
In the
Federal Register of December 28, 2007
(72 FR 73589), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0614. The
approval expires on June 30, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15795 Filed 7–10–08; 8:45 am]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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10
20
60
60
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
BILLING CODE 4160–01–S
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Number of
responses
per respondent
Average
burden hours
per response
1
1
1
1
Total burden
hours
3.5
2.5
3.5
2.5
35
50
210
150
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0464] (formerly
Docket No. 2005N–0403)
Draft Guidance for Industry on
Providing Regulatory Submissions in
Electronic Format—Drug
Establishment Registration and Drug
Listing; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Drug Listing.’’ This draft guidance
document establishes a Pilot Program
for industry to voluntarily submit drug
establishment registration and drug
listing information in an electronic
format that FDA can process, review,
and archive. The document provides
guidance on what required and FDArecommended information related to
drug establishment registration and drug
listing to submit and on how to
electronically prepare and submit the
information to FDA.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance, including comments
regarding proposed collection of
information, by September 9, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Critical Path Programs (HF–
18), Office of the Commissioner, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
the office in processing your requests.
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The draft guidance may also be obtained
by mail by calling the Office of Critical
Path Programs at 301–827–1512. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Lonnie Smith, Office of Critical Path
Programs (HF–18), Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–0011.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 29,
2006 (71 FR 51276), FDA issued a
proposed rule that would revise part
207 (21 CFR part 207) (hereinafter
referred to as ‘‘the 2006 proposed rule’’).
This rule, when finalized, will fully
implement electronic drug
establishment registration and drug
listing. Subsequent to the publication of
the proposed rule, the U.S. Congress
enacted the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85) .
FDAAA amended section 510 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360) (at section
510(p)) to explicitly require the
electronic submission by domestic and
foreign establishments of registration
and listing information (including the
submission of updated information)
required under section 510 of the act,
unless the Secretary of Health and
Human Services grants a request for a
waiver if use of electronic means is not
reasonable for the person requesting the
waiver. FDA intends to exercise
enforcement discretion and does not
intend to take action to enforce this
electronic submission requirement, but
rather intends to pilot voluntary
electronic submission during a
transition period. To assist in complying
with this new statutory provision, and
to test FDA systems for processing such
submissions, FDA is announcing a
voluntary Pilot Program for
electronically submitting drug
establishment registration and drug
listing information and the availability
of a draft guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing.’’
The information collected during drug
establishment registration and drug
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listing information is fundamental to
many processes FDA uses for protecting
the public health, including
surveillance for serious drug adverse
reactions, inspection of facilities used
for drug manufacturing and processing,
and monitoring drug products imported
into the United States. Comprehensive,
complete, up-to-date information is
critical for conducting these activities
with efficiency and effectiveness.
Electronic drug establishment
registration and drug listing using
computer systems to automate this
process will lead to significant
improvements in the timeliness and
accuracy of the information over a
paper-based system. This automation
can be accomplished most efficiently
and effectively when the information is
provided in a standardized format using
defined terminology.
FDA is adopting the use of extensible
markup language (XML) files in a
standard Structured Product Labeling
(SPL)1 format as the standard format for
the exchange of drug establishment
registration and drug listing
information. Information in a properly
created SPL file can be processed in
minutes. In addition, the use of SPL
files with defined terminology will
facilitate the receipt of more precise and
accurate information than was the case
with paper submissions. Timely and
accurate product information will
enhance FDA’s efforts to help ensure the
integrity of the drug supply and protect
the public health.
The draft guidance explains how to
transition from submitting the required
information on paper2 to submitting the
required information using the SPL
standard, an electronic format that FDA
can process, review, and archive. The
draft guidance also describes how to
voluntarily submit additional useful,
but not required, information that
currently is often included by industry
in paper submissions. The draft
1 SPL standard is a Health Level Seven, Inc.,
standard for the exchange of product information
using extensible markup language (XML).
2 Drug establishment registration and drug listing
information is currently submitted in paper format
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). These forms are currently
available at https://www.fda.gov/opacom/
morechoices/fdaforms/fdaforms.html.
3 These technical documents are currently
available at https://www.fda.gov/oc/datacouncil/
spl.html.
4 Under section 351(j) of the Public Health
Service Act, the act and regulations issued under
the act apply to biological products. However, this
guidance document does not apply to establishment
registration and product listing information
required solely under 21 CFR parts 607, 807, and
1271.
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guidance, along with accompanying
technical documents made available on
FDA’s Website3, describes how to
electronically create and submit SPL
files using a defined terminology for
drug establishment registration and drug
listing information (including labeling
as specified under § 207.25) required
under section 510 of the act and part
207.4 In addition to comments on the
draft guidance, FDA also is requesting
comments on the adequacy and
usefulness of the technical documents
that are available on FDA’s Web site.
With publication of the guidance,
FDA is launching a voluntary Pilot
Program that will enable industry to
begin submitting drug establishment
registration and drug listing information
in electronic format. FDA plans to
complete the voluntary Pilot Program
and begin receiving drug establishment
registration and drug listing information
only electronically and in SPL format
(including labeling) beginning June 1,
2009, unless a waiver is granted. Based
on comments received on the draft
guidance and information obtained
during the voluntary Pilot Program,
FDA intends to issue a final guidance
before June 1, 2009.
FDA is still in the process of
considering comments submitted on the
2006 proposed rule. FDA intends to
revise, reissue, or revoke any final
guidance as appropriate, to ensure
consistency with the final rule.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the electronic submission of drug
establishment registration and drug
listing. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one copy.
Comments are to be identified 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
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Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
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III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
(44 U.S.C. 3501–3520) (the PRA),
Federal agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the 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 a 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 on respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
Title: Draft Guidance for Industry on
Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing.
Description of Respondents:
Respondents to this collection of
information are foreign and domestic
owners and operators of establishments
that engage in the manufacture,
preparation, propagation, compounding,
or processing (which includes, among
other things, repackaging and
relabeling) of a drug or drugs5 and that
are not exempt under section 510(g) of
5 Means both human, including biological
products, and animal drugs.
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the act or subpart B of part 207
(registrants).
A. Reporting Burden
The draft guidance describes how to
electronically create and submit SPL
files using defined terminology for
establishment registration and drug
listing information (including labeling).
Most information is already required to
be submitted under section 510 of the
act, section 351 of the Public Health
Service Act, and part 207.
Drug establishment registration and
drug listing information and updates to
such information, required under part
207, and certain additional
recommended information are currently
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; 72 FR 67733,
November 30, 2007).
In addition to the information
collected by the FDA Forms (72 FR
67733, November 30, 2007), the draft
guidance addresses electronic
submission of other required
information as follows:
• For registered foreign drug
establishments, the name, address, and
phone 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 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 act).
FDA also is recommending the
voluntary submission of the following
additional information, when
applicable:
• To facilitate correspondence
between foreign establishments and
FDA, the e-mail address for the U.S.
agent, and the telephone number(s) and
e-mail address for the importer and
person who imports or offers for import
their drug;
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• In providing the labeling as
specified under § 207.25, for
manufacturers with a Web site for
voluntary reporting of adverse drug
reactions, the manufacturer’s telephone
number and URL address that appear on
the label under 21 CFR 201.57(a)(11);
• A site-specific D-U-N-S Number6
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;
• A reference drug if used as a basis
for the strength of the listed drug;
• 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 (ESG) 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.
B. Burden Estimates
Reporting Burden—The estimates for
the number of respondents, annual
frequency per response, and total
annual responses indicated in table 1 of
this document are based on our current
estimates of the number of registrants
and the number of submissions using
the FDA Forms (OMB Control No. 0910–
0045). FDA estimates that it would take
an additional 2 hours per response (in
addition to the estimated 2.5 hours per
6 A D&B D-U-N-S Number is a unique ninedigit sequence recognized as the universal standard
for identifying and keeping track of over 100
million business worldwide. Submitting the sitespecific D-U-N-S Number for an entity would
provide by reference to the number certain business
information for that entity, e.g., address, parentage.
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response for registering, labeler code
requests, listing, and providing updates
to the information approved under OMB
Control No. 0910–0045) for the
collection of information not currently
submitted using the FDA Forms, and to
create and upload the SPL file. FDA
anticipates that the hours per response
will decrease over time due to the
flexibility of submitting information for
registering multiple establishments or
listing multiple drugs in one SPL file
instead of submitting individual FDA
Forms, and increasing familiarity with
the use of the standards and
terminology for creating the SPL file.
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. Because
registrants will only need a computer
and access to the Internet, FDA
envisions few instances in which
electronic submission of registration
and listing information will not be
reasonable for the person requesting the
waiver and, thus, is estimating that FDA
would grant one waiver annually. We
estimate that a one-time burden for
requesting a waiver would be an hour of
time for a mid-level manager to draft,
approve, and mail a letter.
Recordkeeping Burden—In table 2 of
this document, FDA estimates that 3,295
(39 + 3,256) respondents would expend
a one-time burden of approximately 40
hours in preparing, reviewing, and
approving an SOP for creating and
uploading the SPL file; and an estimated
1 hour annually to maintain the SOP as
needed.
FDA estimates the information
collection burden, in addition to that
approved under OMB Control No. 0910–
0045 as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
New registrations, including new labeler code requests
39
14.72
574
2
1,148
Annual updates of registration information
3,256
2.99
9,735
2
19,470
New drug listings
1,567
6.57
10,295
2
20,590
146
10.06
1,469
2
2,938
1,677
11.21
18,799
2
37,598
1
1
1
New listings for private label distributors
June and December updates of all
drug listing information
Waiver requests
1
1
Total
1 There
81,745
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Activity
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
One-time preparation of SOP
3,295
1
3,295
40
131,800
SOP maintenance
3,295
1
3,295
1
3,295
Total
1 There
135,095
are no capital costs or operating and maintenance costs associated with this collection of information.
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C. Costs Associated with Electronic
Submission
There are no capital costs or operating
and maintenance costs associated with
the transition from paper to electronic
submissions. To create an SPL file and
submit it to FDA, a registrant would
need the following tools: A computer,
appropriate software, access to the
Internet, knowledge of terminology and
standards, and access to FDA’s
Electronic Submission Gateway (ESG).
Registrants (and most individuals)
have computers and Internet access
available for their use. If a business does
not have an available computer or
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access to the Internet, free use of
computers and Internet are usually
available at public facilities, e.g., a
community library; or they may request
a waiver from submitting the
information electronically.
Software is necessary to create a
‘‘document.’’ The SPL file or
‘‘document’’ may be created internally
by a business with experience with SPL,
or a business may use a user-friendly
software (XForms)7 available at no cost
7 See https://www.fda.gov/oc/datacouncil/
xforms.html.
8 See https://www.fda.gov/oc/datacouncil/
spl.html.
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for industry use. In addition to the
software, FDA also provides technical
assistance, and other resources,
terminology, and data standards
regarding SPL files.8
Once the SPL file is created, the
registrant would upload the file through
the ESG. A digital certificate is needed
to use the ESG. The digital certificate
binds together the owner’s name and a
pair of electronic keys (a public key and
a private key) that can be used to
encrypt and sign documents. However,
a small fee of up to $20.00 is charged
for the digital certificate and the
registrant may need to renew the
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certificate not less than annually. FDA
is not calculating this small fee as cost
of doing business because it is less than
or equal to the biannual courier costs
the registrant incurs for paper
submissions.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, https://www.fda.gov/
cvm/guidance/guidance.html, and
https://www.regulations.gov.
Dated: July 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15801 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2008–D–0372]
Global Harmonization Task Force,
Study Groups 1 and 5; Proposed and
Final Documents; Availability
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of final and proposed
documents that have been prepared by
Study Groups 1 and 5 of the Global
Harmonization Task Force (GHTF),
respectively. These documents
represent a harmonized proposal and
recommendation from the GHTF Study
Groups that may be used by
governments developing and updating
their regulatory requirements for
medical devices. These documents are
intended to provide information only
and do not describe FDA’s current
regulatory requirements; elements of
these documents may not be consistent
with current U.S. regulatory
requirements. In particular, FDA seeks
comments on the advantages and
disadvantages of the approaches in the
GHTF documents, particularly where
they are not consistent with current
practices for the manufacture of
products in the United States.
DATES: Submit written or electronic
comments on these documents by
October 9, 2008. After October 9, 2008,
written comments or electronic
comments may be submitted at any time
to the contact persons listed in this
document.
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17:19 Jul 10, 2008
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Submit written requests for
single copies of these documents to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
documents.
Submit written comments concerning
these documents to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.reguations.gov. Identify comments
with the docket number found in
brackets in the heading of this
document.
ADDRESSES:
For information regarding Study
Group 1:Ginette Y. Michaud,
Chairperson, GHTF, Study Group 1,
Office of Device Evaluation,Center
for Devices and Radiological Health
(HFZ–480), Food and Drug
Administration,9200 Corporate
Blvd., Rockville, MD 20850, 240–
276–3700.
For information regarding Study
Group 5:Herbert P. Lerner, GHTF,
Study Group 5, Office of Device
Evaluation, Center for Devices and
Radiological Health (HFZ–470),
Food and Drug Administration,
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–3641.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has participated in a number of
activities to promote the international
harmonization of regulatory
requirements. In September 1992, a
meeting was held in Nice, France by
senior regulatory officials to evaluate
international harmonization. This
meeting led to the development of the
organization now known as the GHTF to
facilitate harmonization. Subsequent
meetings have been held in various
locations throughout the world.
The GHTF is a voluntary group of
representatives from national medical
device regulatory authorities and the
regulated industry. Since its inception,
the GHTF has been comprised of
representatives from five founding
members grouped into three
geographical areas: Europe, Asia-Pacific,
and North America, each of which
actively regulates medical devices using
its own unique regulatory framework.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
The objective of the GHTF is to
encourage convergence at the global
level of regulatory systems of medical
devices to facilitate trade while
preserving the right of participating
members to address the protection of
public health by regulatory means
considered most suitable. One of the
ways this objective is achieved is by
identifying and developing areas of
international cooperation to facilitate
progressive reduction of technical and
regulatory differences in systems
established to regulate medical devices.
In an effort to accomplish these
objectives, the GHTF formed five study
groups to draft documents and carry on
other activities designed to facilitate
global harmonization. This notice
relates to documents that have been
developed by two of the Study Groups
(1 and 5).
Study Group 1 was initially tasked
with the responsibility of identifying
differences between various regulatory
systems. In 1995, the group was asked
to propose areas of potential
harmonization for premarket device
regulations and possible guidelines that
could help lead to harmonization. As a
result of its efforts, this group has
developed final document SG1/
N44:2008. SG1/N44:2008 (final
document) entitled ‘‘Role of Standards’’
provides information on the use of
standards by a manufacturer when
designing a medical device and,
subsequently, when demonstrating that
the device conforms to relevant
essential safety and performance
criteria.
Study Group 5 was initially tasked
with the responsibility of developing
documents on the content and format
for clinical investigation reports and on
how to conduct and document a clinical
evaluation. As a result of its efforts, this
group has developed proposed
document SG5(PD)/N37:2007. The
proposed document SG5(PD)/N37:2007
entitled ‘‘Clinical Investigations’’
introduces general principles of clinical
investigations of medical devices and
general principles when considering the
need for a clinical investigation of a
medical device. This document
primarily addresses the use of clinical
investigations to support a marketing
authorization application.
II. Significance of Guidance
These documents represent
recommendations from the GHTF study
groups and do not describe regulatory
requirements. FDA is making these
documents available so that industry
and other members of the public may
express their views and opinions. In
particular, FDA seeks comments on the
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 73, Number 134 (Friday, July 11, 2008)]
[Notices]
[Pages 39964-39968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15801]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0464] (formerly Docket No. 2005N-0403)
Draft Guidance for Industry on Providing Regulatory Submissions
in Electronic Format--Drug Establishment Registration and Drug Listing;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Drug Establishment
Registration and Drug Listing.'' This draft guidance document
establishes a Pilot Program for industry to voluntarily submit drug
establishment registration and drug listing information in an
electronic format that FDA can process, review, and archive. The
document provides guidance on what required and FDA-recommended
information related to drug establishment registration and drug listing
to submit and on how to electronically prepare and submit the
information to FDA.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance,
including comments regarding proposed collection of information, by
September 9, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Critical Path Programs (HF-18), Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
the office in processing your requests.
[[Page 39965]]
The draft guidance may also be obtained by mail by calling the Office
of Critical Path Programs at 301-827-1512. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lonnie Smith, Office of Critical Path
Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-0011.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 29, 2006 (71 FR 51276), FDA
issued a proposed rule that would revise part 207 (21 CFR part 207)
(hereinafter referred to as ``the 2006 proposed rule''). This rule,
when finalized, will fully implement electronic drug establishment
registration and drug listing. Subsequent to the publication of the
proposed rule, the U.S. Congress enacted the Food and Drug
Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) .
FDAAA amended section 510 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360) (at section 510(p)) to explicitly require the
electronic submission by domestic and foreign establishments of
registration and listing information (including the submission of
updated information) required under section 510 of the act, unless the
Secretary of Health and Human Services grants a request for a waiver if
use of electronic means is not reasonable for the person requesting the
waiver. FDA intends to exercise enforcement discretion and does not
intend to take action to enforce this electronic submission
requirement, but rather intends to pilot voluntary electronic
submission during a transition period. To assist in complying with this
new statutory provision, and to test FDA systems for processing such
submissions, FDA is announcing a voluntary Pilot Program for
electronically submitting drug establishment registration and drug
listing information and the availability of a draft guidance for
industry entitled ``Providing Regulatory Submissions in Electronic
Format--Drug Establishment Registration and Drug Listing.''
The information collected during drug establishment registration
and drug listing information is fundamental to many processes FDA uses
for protecting the public health, including surveillance for serious
drug adverse reactions, inspection of facilities used for drug
manufacturing and processing, and monitoring drug products imported
into the United States. Comprehensive, complete, up-to-date information
is critical for conducting these activities with efficiency and
effectiveness. Electronic drug establishment registration and drug
listing using computer systems to automate this process will lead to
significant improvements in the timeliness and accuracy of the
information over a paper-based system. This automation can be
accomplished most efficiently and effectively when the information is
provided in a standardized format using defined terminology.
FDA is adopting the use of extensible markup language (XML) files
in a standard Structured Product Labeling (SPL)\1\ format as the
standard format for the exchange of drug establishment registration and
drug listing information. Information in a properly created SPL file
can be processed in minutes. In addition, the use of SPL files with
defined terminology will facilitate the receipt of more precise and
accurate information than was the case with paper submissions. Timely
and accurate product information will enhance FDA's efforts to help
ensure the integrity of the drug supply and protect the public health.
---------------------------------------------------------------------------
\1\ SPL standard is a Health Level Seven, Inc., standard for the
exchange of product information using extensible markup language
(XML).
---------------------------------------------------------------------------
The draft guidance explains how to transition from submitting the
required information on paper\2\ to submitting the required information
using the SPL standard, an electronic format that FDA can process,
review, and archive. The draft guidance also describes how to
voluntarily submit additional useful, but not required, information
that currently is often included by industry in paper submissions. The
draft guidance, along with accompanying technical documents made
available on FDA's Website\3\, describes how to electronically create
and submit SPL files using a defined terminology for drug establishment
registration and drug listing information (including labeling as
specified under Sec. 207.25) required under section 510 of the act and
part 207.\4\ In addition to comments on the draft guidance, FDA also is
requesting comments on the adequacy and usefulness of the technical
documents that are available on FDA's Web site.
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\2\ Drug establishment registration and drug listing information
is currently submitted in paper format 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). These forms
are currently available at https://www.fda.gov/opacom/morechoices/
fdaforms/fdaforms.html.
\3\ These technical documents are currently available at https://
www.fda.gov/oc/datacouncil/spl.html.
\4\ Under section 351(j) of the Public Health Service Act, the
act and regulations issued under the act apply to biological
products. However, this guidance document does not apply to
establishment registration and product listing information required
solely under 21 CFR parts 607, 807, and 1271.
---------------------------------------------------------------------------
With publication of the guidance, FDA is launching a voluntary
Pilot Program that will enable industry to begin submitting drug
establishment registration and drug listing information in electronic
format. FDA plans to complete the voluntary Pilot Program and begin
receiving drug establishment registration and drug listing information
only electronically and in SPL format (including labeling) beginning
June 1, 2009, unless a waiver is granted. Based on comments received on
the draft guidance and information obtained during the voluntary Pilot
Program, FDA intends to issue a final guidance before June 1, 2009.
FDA is still in the process of considering comments submitted on
the 2006 proposed rule. FDA intends to revise, reissue, or revoke any
final guidance as appropriate, to ensure consistency with the final
rule.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
electronic submission of drug establishment registration and drug
listing. 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one copy. Comments
are to be identified 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.
Please note that on January 15, 2008, the FDA Division of Dockets
[[Page 39966]]
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the 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 a 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 on respondents, including
through the use of automated collection techniques, when appropriate,
and other forms of information technology.
Title: Draft Guidance for Industry on Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.
Description of Respondents: Respondents to this collection of
information are foreign and domestic owners and operators of
establishments that engage in the manufacture, preparation,
propagation, compounding, or processing (which includes, among other
things, repackaging and relabeling) of a drug or drugs\5\ and that are
not exempt under section 510(g) of the act or subpart B of part 207
(registrants).
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\5\ Means both human, including biological products, and animal
drugs.
---------------------------------------------------------------------------
A. Reporting Burden
The draft guidance describes how to electronically create and
submit SPL files using defined terminology for establishment
registration and drug listing information (including labeling). Most
information is already required to be submitted under section 510 of
the act, section 351 of the Public Health Service Act, and part 207.
Drug establishment registration and drug listing information and
updates to such information, required under part 207, and certain
additional recommended information are currently 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; 72 FR 67733, November 30,
2007).
In addition to the information collected by the FDA Forms (72 FR
67733, November 30, 2007), the draft guidance addresses electronic
submission of other required information as follows:
For registered foreign drug establishments, the name,
address, and phone 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 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 act).
FDA also is recommending the voluntary submission of the following
additional information, when applicable:
To facilitate correspondence between foreign
establishments and FDA, the e-mail address for the U.S. agent, and the
telephone number(s) and e-mail address for the importer and person who
imports or offers for import their drug;
In providing the labeling as specified under Sec. 207.25,
for manufacturers with a Web site for voluntary reporting of adverse
drug reactions, the manufacturer's telephone number and URL address
that appear on the label under 21 CFR 201.57(a)(11);
A site-specific D-U-N-S[reg] Number\6\ for each entity
(e.g., the registrant, establishments, U.S. agent, importer);
---------------------------------------------------------------------------
\6\ A D&B[reg] D-U-N-S[reg] Number is a unique nine-digit
sequence recognized as the universal standard for identifying and
keeping track of over 100 million business worldwide. Submitting the
site-specific D-U-N-S[reg] Number for an entity would provide by
reference to the number certain business information for that
entity, e.g., address, parentage.
---------------------------------------------------------------------------
The NDC product code for the source drug that is repacked
or relabeled;
A reference drug if used as a basis for the strength of
the listed drug;
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 (ESG) 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.
B. Burden Estimates
Reporting Burden--The estimates for the number of respondents,
annual frequency per response, and total annual responses indicated in
table 1 of this document are based on our current estimates of the
number of registrants and the number of submissions using the FDA Forms
(OMB Control No. 0910-0045). FDA estimates that it would take an
additional 2 hours per response (in addition to the estimated 2.5 hours
per
[[Page 39967]]
response for registering, labeler code requests, listing, and providing
updates to the information approved under OMB Control No. 0910-0045)
for the collection of information not currently submitted using the FDA
Forms, and to create and upload the SPL file. FDA anticipates that the
hours per response will decrease over time due to the flexibility of
submitting information for registering multiple establishments or
listing multiple drugs in one SPL file instead of submitting individual
FDA Forms, and increasing familiarity with the use of the standards and
terminology for creating the SPL file.
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. Because
registrants will only need a computer and access to the Internet, FDA
envisions few instances in which electronic submission of registration
and listing information will not be reasonable for the person
requesting the waiver and, thus, is estimating that FDA would grant one
waiver annually. We estimate that a one-time burden for requesting a
waiver would be an hour of time for a mid-level manager to draft,
approve, and mail a letter.
Recordkeeping Burden--In table 2 of this document, FDA estimates
that 3,295 (39 + 3,256) respondents would expend a one-time burden of
approximately 40 hours in preparing, reviewing, and approving an SOP
for creating and uploading the SPL file; and an estimated 1 hour
annually to maintain the SOP as needed.
FDA estimates the information collection burden, in addition to
that approved under OMB Control No. 0910-0045 as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
New 39 14.72 574 2 1,148
registrations
, including
new labeler
code requests
----------------------------------------------------------------------------------------------------------------
Annual updates 3,256 2.99 9,735 2 19,470
of
registration
information
----------------------------------------------------------------------------------------------------------------
New drug 1,567 6.57 10,295 2 20,590
listings
----------------------------------------------------------------------------------------------------------------
New listings 146 10.06 1,469 2 2,938
for private
label
distributors
----------------------------------------------------------------------------------------------------------------
June and 1,677 11.21 18,799 2 37,598
December
updates of
all drug
listing
information
----------------------------------------------------------------------------------------------------------------
Waiver 1 1 1 1 1
requests
----------------------------------------------------------------------------------------------------------------
Total 81,745
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Activity Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
One-time 3,295 1 3,295 40 131,800
preparation of
SOP
----------------------------------------------------------------------------------------------------------------
SOP maintenance 3,295 1 3,295 1 3,295
----------------------------------------------------------------------------------------------------------------
Total 135,095
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
C. Costs Associated with Electronic Submission
There are no capital costs or operating and maintenance costs
associated with the transition from paper to electronic submissions. To
create an SPL file and submit it to FDA, a registrant would need the
following tools: A computer, appropriate software, access to the
Internet, knowledge of terminology and standards, and access to FDA's
Electronic Submission Gateway (ESG).
Registrants (and most individuals) have computers and Internet
access available for their use. If a business does not have an
available computer or access to the Internet, free use of computers and
Internet are usually available at public facilities, e.g., a community
library; or they may request a waiver from submitting the information
electronically.
Software is necessary to create a ``document.'' The SPL file or
``document'' may be created internally by a business with experience
with SPL, or a business may use a user-friendly software (XForms)\7\
available at no cost for industry use. In addition to the software, FDA
also provides technical assistance, and other resources, terminology,
and data standards regarding SPL files.\8\
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\7\ See https://www.fda.gov/oc/datacouncil/xforms.html.
\8\ See https://www.fda.gov/oc/datacouncil/spl.html.
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Once the SPL file is created, the registrant would upload the file
through the ESG. A digital certificate is needed to use the ESG. The
digital certificate binds together the owner's name and a pair of
electronic keys (a public key and a private key) that can be used to
encrypt and sign documents. However, a small fee of up to $20.00 is
charged for the digital certificate and the registrant may need to
renew the
[[Page 39968]]
certificate not less than annually. FDA is not calculating this small
fee as cost of doing business because it is less than or equal to the
biannual courier costs the registrant incurs for paper submissions.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/
guidelines.htm, https://www.fda.gov/cvm/guidance/guidance.html, and
https://www.regulations.gov.
Dated: July 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15801 Filed 7-10-08; 8:45 am]
BILLING CODE 4160-01-S
