Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing, 63158-63161 [E8-25338]
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Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health related
condition only where that statement
meets the requirements of the
regulations promulgated by the
Secretary of Health and Human Services
to authorize the use of such a health
claim. Section 101.82 (21 CFR 101.82) of
FDA’s regulations authorizes a health
claim for food labels about soy protein
and the risk of coronary heart disease.
To bear the soy protein/coronary heart
disease health claim, foods must contain
at least 6.25 grams of soy protein per
reference amount customarily
consumed. Analytical methods for
measuring total protein can be used to
quantify the amount of soy protein in
foods that contain soy as the sole source
of protein. However, at the present time
there is no validated analytical
methodology available to quantify the
amount of soy protein in foods that
contain other sources of protein. For
these latter foods, FDA must rely on
information known only to the
manufacturer to assess compliance with
the requirement that the food contain
the qualifying amount of soy protein.
Thus, FDA requires manufacturers to
have and keep records to substantiate
the amount of soy protein in a food that
bears the health claim and contains
sources of protein other than soy, and to
make such records available to
appropriate regulatory officials upon
written request. The information
collected includes nutrient databases or
analyses, recipes or formulations,
purchase orders for ingredients, or any
other information that reasonably
substantiates the ratio of soy protein to
total protein.
FDA estimates the burden of this
collection of information as follows:
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Record-keepers
21 CFR Part
101.82(c)(2)(ii)(B)
1 There
25
Total Annual
Records
1
Hours per
Recordkeeper
25
Total Hours
1
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based upon the agency’s experience
with the use of health claims, FDA
estimates that only about 25 firms
would be likely to market products
bearing a soy protein/coronary heart
disease health claim and that only,
perhaps, one of each firm’s products
might contain nonsoy sources of protein
along with soy protein. The records
required to be retained by
§ 101.82(c)(2)(ii)(B) are the records, e.g.,
the formulation or recipe, that a
manufacturer has and maintains as a
normal course of its doing business.
Thus, the burden to the food
manufacturer is that involved in
assembling and providing the records to
appropriate regulatory officials for
review or copying.
Please note that on January 15, 2008,
the FDA Division of Dockets
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.
dwashington3 on PRODPC61 with NOTICES
Annual Frequency
of Recordkeeping
Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25336 Filed 10–22–08; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0464]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry on Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Drug Listing
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 November
24, 2008.
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:
202–395–6974, or e-mailed 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.
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Draft Guidance for Industry on
Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing;
Availability; Registration of Producers
at Drugs and Listing of Drugs in
Commercial Distribution—(OMB
Control Number 0910–0045—
Amendment)
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 drugs1 and that
are not exempt under section 510(g) of
the Federal Food, Drug, and Cosmetic
Act or subpart B of 21 CFR part 207
(part 207) (registrants).
A. Reporting Burden
The draft guidance describes how to
electronically create and submit
Structured Product Labeling (SPL) files
using defined terminology for
establishment registration and drug
1 Means both human, including biological
products, and animal drugs.
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dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
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
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 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 § 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);
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• A site-specific D-U-N-S Number2
for each entity (e.g., the registrant,
establishments, U.S. agent, importer);
• The National Drug Code 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
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
2 D&B D-U-N-S Number is a unique nine-digit
sequence recognized as the universal standard for
identifying and keeping track of over 100 million
businesses worldwide. Submitting the site-specific
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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63159
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.
In the Federal Register of July 11,
2008 (73 FR 39964), FDA published a
draft notice of availability requesting
public comment on the information
collection provisions. Nineteen
comments were received of which 4
remarked on the information collection.
(Comment 1) On the topic 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, one comment agreed that the
proposed collection of information is
necessary for us to perform its functions
and is consistent with the provisions of
the Food and Drug Administration
Amendments Act of 2007 (Public Law
110–85). The comment continued to say
that the information is also necessary to
support the transition from paper format
to electronic format, and that the
additional information requested by us
is logical and reasonable and is not an
undue burden.
(Response) We appreciate the support
and concurrence of the comment.
(Comment 2) On the topic whether
the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used,
one comment stated that we
underestimated the effort to prepare,
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Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
review, approve, implement and
maintain internal SOPs for electronic
submission of drug establishment
registration and drug listing information
because of the following reason.
Particularly for most large companies,
drug establishment registration and drug
listing information (currently submitted
in paper format under 21 CFR 207.22)
and content of labeling (currently
submitted in electronic format under 21
CFR 314.50(l)(1)(i)) are handled by
completely different functional experts
and/or departments in the companies.
To coordinate these processes,
additional time is needed to define new
procedures and interactions that cross
functional departments and possibly
international groups. Therefore, large
companies will expend more than 40
hours to prepare, review, approve,
implement and maintain SOPs.
Another comment asserts that the
hours per response in table 1 of this
document are underestimated if the
estimate accounts for the time required
to become familiar with the SPL
standard.
(Response) In estimating hours per
record in table 2 of this document, we
considered the various sizes of entities
affected and proposed an average
number of hours per activity. For
example, the estimated 40 hours per
record are based on smaller entities
requiring approximately 20 hours per
record and larger entities requiring
approximately 60 hours per record.
Therefore, because the comment did not
provide a revised estimate, we are
maintaining an estimate of 40 hours per
record, which is consistent with
preparing SOPs for paper format
submissions and also includes
coordination efforts.
Regarding the comment on
underestimating the hours per response
in table 1, the software designed to
create the SPL files, the step-by-step
instructions in the technical guides, and
our technical assistance e-mail address
are provided by us for the purpose of
minimizing the need to learn the SPL
standard before submitting information
electronically.
(Comment 3) On the topic of 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, one comment
encouraged us to continue the
availability of Xforms at no cost for
industry to use as a software tool for the
creation of SPL. The comment also
requested that we continue this practice
as technology evolves and provide
support for this tool.
(Response) We appreciate the
encouragement of the comment and will
consider the request to continue the
practice and provide support as
technology evolves.
(Comment 4) Two comments did not
agree with our statement that there are
no capital or operating and maintenance
costs associated with the collection of
information. The comments explained
that some companies may choose
alternative tools to the Xform software
or work with external conversion
providers, which may involve the
purchase and maintenance of software
plus the use of internal information
technology personnel for installation,
configuration, and maintenance. These
comments further stated that these costs
are significant and need to be
considered in the overall cost for
industry to comply with the electronic
submission requirement.
(Response) As the comments stated,
companies may choose to use
alternative tools or work with external
conversion providers. We do not
disagree. However, we have made every
effort to eliminate costs to industry to
comply with the statutory requirement
to electronically submit drug
establishment registration and drug
listing information.
We also received comments that were
specifically related to the technical
documents referenced in the draft
guidance. Although these comments are
not directly related to the draft guidance
document that contains the information
collection, we will consider the
comments when reviewing the technical
documents for revision.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
New registrations, including new labeler
code requests
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
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
New listings for private label distributors
146
10.06
1,469
2
2,938
June and December updates of all drug
listing information
1,677
11.21
18,799
2
37,598
1
1
1
1
1
Waiver requests
Total
1 There
81,745
are no capital costs or operating and maintenance costs associated with this collection of information.
dwashington3 on PRODPC61 with NOTICES
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
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Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
63161
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
Activity
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total
1 There
135,095
are no capital costs or operating and maintenance costs associated with this collection of information.
C. Costs Associated With Electronic
Submission
dwashington3 on PRODPC61 with NOTICES
Total Hours
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 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)3 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.4
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
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.
3 See https://www.fda.gov/oc/datacouncil/
xforms.html.
4 See https://www.fda.gov/oc/datacouncil/
spl.html.
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14:58 Oct 22, 2008
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Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25338 Filed 10–22–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of federally
funded research and development.
Foreign patent applications are filed on
selected inventions to extend market
coverage for companies and may also be
available for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Development of Mutations Useful for
Attenuating Dengue Viruses and
Chimeric Dengue Viruses
Description of Technology: Although
flaviviruses cause a great deal of human
suffering and economic loss, there is a
shortage of effective vaccines. This
invention relates to dengue virus
mutations that may contribute to the
development of improved dengue
vaccines. Site directed and random
mutagenesis techniques were used to
introduce mutations into the dengue
virus genome and to assemble a
collection of useful mutations for
incorporation in recombinant live
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attenuated dengue virus vaccines. The
resulting mutant viruses were screened
for several valuable phenotypes,
including temperature sensitivity in
Vero cells or human liver cells, host cell
restriction in mosquito cells or human
liver cells, host cell adaptation for
improved replication in Vero cells, and
attenuation in mice or in mosquitoes.
The genetic basis for each observed
phenotype was determined by direct
sequence analysis of the genome of the
mutant virus. Mutations identified
through these sequencing efforts have
been further evaluated by reintroduction of the identified mutations,
singly, or in combination, into
recombinant dengue virus and
characterization of the resulting
recombinant virus for phenotypes. In
this manner, a menu of attenuating and
growth promoting mutations was
developed that is useful in fine-tuning
the attenuation and growth
characteristics of dengue virus vaccine
candidates. The mutations promoting
growth in Vero cells have usefulness for
the production of live or inactivated
dengue virus vaccines.
Inventors: Stephen S. Whitehead,
Brian R. Murphy, Kathryn A. Hanley,
Joseph E. Blaney (NIAID).
Patent Status: U.S. Patent No.
7,226,602 issued 05 Jun 2007 (HHS
Reference No. E–120–2001/0–US–04);
U.S. Patent Application No. 11/446,050
filed 02 Jun 2006 (HHS Reference No.
E–120–2001/0–US–10).
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases, Laboratory of
Infectious Diseases, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize these vaccines. Please
contact Dr. Brian Murphy at 301–594–
1616 or bm25f@nih.gov for more
information.
Dengue Tetravalent Vaccine Containing
a Common 30 Nucleotide Deletion in
the 3′-UTR of Dengue Types 1, 2, 3, and
4
Description of Technology: The
invention relates to a dengue virus
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]]>Agencies
[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63158-63161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25338]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0464]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry on Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing
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
November 24, 2008.
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: 202-395-6974, or e-mailed 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: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Draft Guidance for Industry on Providing Regulatory Submissions in
Electronic Format--Drug Establishment Registration and Drug Listing;
Availability; Registration of Producers at Drugs and Listing of Drugs
in Commercial Distribution--(OMB Control Number 0910-0045--Amendment)
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\1\ and that are
not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic
Act or subpart B of 21 CFR part 207 (part 207) (registrants).
---------------------------------------------------------------------------
\1\ Means both human, including biological products, and animal
drugs.
---------------------------------------------------------------------------
A. Reporting Burden
The draft guidance describes how to electronically create and
submit Structured Product Labeling (SPL) files using defined
terminology for establishment registration and drug
[[Page 63159]]
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 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 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\2\ for each entity
(e.g., the registrant, establishments, U.S. agent, importer);
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\2\ 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 businesses 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 National Drug Code 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 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.
In the Federal Register of July 11, 2008 (73 FR 39964), FDA
published a draft notice of availability requesting public comment on
the information collection provisions. Nineteen comments were received
of which 4 remarked on the information collection.
(Comment 1) On the topic 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, one
comment agreed that the proposed collection of information is necessary
for us to perform its functions and is consistent with the provisions
of the Food and Drug Administration Amendments Act of 2007 (Public Law
110-85). The comment continued to say that the information is also
necessary to support the transition from paper format to electronic
format, and that the additional information requested by us is logical
and reasonable and is not an undue burden.
(Response) We appreciate the support and concurrence of the
comment.
(Comment 2) On the topic whether the accuracy of FDA's estimate of
the burden of the proposed collection of information, including the
validity of the methodology and assumptions used, one comment stated
that we underestimated the effort to prepare,
[[Page 63160]]
review, approve, implement and maintain internal SOPs for electronic
submission of drug establishment registration and drug listing
information because of the following reason. Particularly for most
large companies, drug establishment registration and drug listing
information (currently submitted in paper format under 21 CFR 207.22)
and content of labeling (currently submitted in electronic format under
21 CFR 314.50(l)(1)(i)) are handled by completely different functional
experts and/or departments in the companies. To coordinate these
processes, additional time is needed to define new procedures and
interactions that cross functional departments and possibly
international groups. Therefore, large companies will expend more than
40 hours to prepare, review, approve, implement and maintain SOPs.
Another comment asserts that the hours per response in table 1 of
this document are underestimated if the estimate accounts for the time
required to become familiar with the SPL standard.
(Response) In estimating hours per record in table 2 of this
document, we considered the various sizes of entities affected and
proposed an average number of hours per activity. For example, the
estimated 40 hours per record are based on smaller entities requiring
approximately 20 hours per record and larger entities requiring
approximately 60 hours per record. Therefore, because the comment did
not provide a revised estimate, we are maintaining an estimate of 40
hours per record, which is consistent with preparing SOPs for paper
format submissions and also includes coordination efforts.
Regarding the comment on underestimating the hours per response in
table 1, the software designed to create the SPL files, the step-by-
step instructions in the technical guides, and our technical assistance
e-mail address are provided by us for the purpose of minimizing the
need to learn the SPL standard before submitting information
electronically.
(Comment 3) On the topic of 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, one comment encouraged us to continue the availability of
Xforms at no cost for industry to use as a software tool for the
creation of SPL. The comment also requested that we continue this
practice as technology evolves and provide support for this tool.
(Response) We appreciate the encouragement of the comment and will
consider the request to continue the practice and provide support as
technology evolves.
(Comment 4) Two comments did not agree with our statement that
there are no capital or operating and maintenance costs associated with
the collection of information. The comments explained that some
companies may choose alternative tools to the Xform software or work
with external conversion providers, which may involve the purchase and
maintenance of software plus the use of internal information technology
personnel for installation, configuration, and maintenance. These
comments further stated that these costs are significant and need to be
considered in the overall cost for industry to comply with the
electronic submission requirement.
(Response) As the comments stated, companies may choose to use
alternative tools or work with external conversion providers. We do not
disagree. However, we have made every effort to eliminate costs to
industry to comply with the statutory requirement to electronically
submit drug establishment registration and drug listing information.
We also received comments that were specifically related to the
technical documents referenced in the draft guidance. Although these
comments are not directly related to the draft guidance document that
contains the information collection, we will consider the comments when
reviewing the technical documents for revision.
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 of 3,256 2.99 9,735 2 19,470
registration
information
----------------------------------------------------------------------------------------------------------------
New drug listings 1,567 6.57 10,295 2 20,590
----------------------------------------------------------------------------------------------------------------
New listings for 146 10.06 1,469 2 2,938
private label
distributors
----------------------------------------------------------------------------------------------------------------
June and December 1,677 11.21 18,799 2 37,598
updates of all
drug listing
information
----------------------------------------------------------------------------------------------------------------
Waiver requests 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[Page 63161]]
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
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)\3\
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.\4\
---------------------------------------------------------------------------
\3\ See https://www.fda.gov/oc/datacouncil/xforms.html.
\4\ 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 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.
Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25338 Filed 10-22-08; 8:45 am]
BILLING CODE 4160-01-S
