Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 15214-15217 [2015-06497]
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15214
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
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delivery. The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
AHRQ has accepted a notification of
voluntary relinquishment from PSO
Services Group of its status as a PSO,
and has delisted the PSO accordingly.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on January 5, 2015.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130; Email: PSO@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
federally approved PSOs.
AHRQ has accepted a notification
from PSO Services Group, PSO number
P0028, to voluntarily relinquish its
status as a PSO. Accordingly, PSO
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Services Group was delisted effective at
12:00 Midnight ET (2400) on January 5,
2015.
PSO Services Group has patient safety
work product (PSWP) in its possession.
The PSO will meet the requirements of
section 3.108(c)(2)(i) of the Patient
Safety Rule regarding notification to
providers that have reported to the PSO.
In addition, according to sections
3.108(c)(2)(ii) and 3.108(b)(3) of the
Patient Safety Rule regarding
disposition of PSWP, the PSO has 90
days from the effective date of delisting
and revocation to complete the
disposition of PSWP that is currently in
the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov/
index.html.
Dated: March 17, 2015.
Sharon B. Arnold,
Deputy Director, AHRQ.
[FR Doc. 2015–06455 Filed 3–20–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the requirements for drug establishment
registration and drug listing.
DATES: Submit either electronic or
written comments on the collection of
information by May 22, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
SUMMARY:
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information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002; PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution—21 CFR Part 207 (OMB
Control Number 0910–0045)—Extension
Requirements for drug establishment
registration and drug listing are set forth
in section 510 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360), section 351 of the
Public Health Service Act (42 U.S.C.
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
262), and part 207 (21 CFR part 207).
Fundamental to FDA’s mission to
protect the public health is the
collection of this information, which is
used for important activities such as
postmarket surveillance for serious
adverse drug reactions, inspection of
drug manufacturing and processing
facilities, and monitoring of drug
products imported into the United
States. Comprehensive, accurate, and up
to date information is critical to
conducting these activities with
efficiency and effectiveness.
Under section 510 of the FD&C Act,
FDA is authorized to establish a system
for registration of producers of drugs
and for listing of drugs in commercial
distribution. To implement section 510
of the FD&C Act, FDA issued part 207.
Under current § 207.20, manufacturers,
repackers, and relabelers that engage in
the manufacture, preparation,
propagation, compounding, or
processing of human or veterinary drugs
and biological products, including bulk
drug substances and bulk drug
substances for prescription
compounding, and drug premixes as
well as finished dosage forms, whether
prescription or over-the-counter, are
required to register their establishment.
In addition, manufacturers, repackers,
and relabelers are required to submit a
listing of every drug or biological
product in commercial distribution.
Owners or operators of establishments
that distribute under their own label or
trade name a drug product
manufactured by a registered
establishment are not required either to
register or list. However, distributors
may elect to submit drug listing
information in lieu of the registered
establishment that manufactures the
drug product. Foreign drug
establishments must also comply with
the establishment registration and
product listing requirements if they
import or offer for import their products
into the United States.
Under current § 207.21,
establishments, both domestic and
foreign, must register with FDA within
5 days after beginning the manufacture
of drugs or biologicals, or within 5 days
after the submission of a drug
application or biological license
application. In addition, establishments
must register annually. Changes in
individual ownership, corporate or
partnership structure, location, or drug
handling activity must be submitted as
amendments to registration under
current § 207.26 within 5 days of such
changes. Under § 207.20(b), private label
distributors may request their own
labeler code and elect to submit drug
listing information to FDA. In such
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instances, at the time of submitting or
updating drug listing information,
private label distributors must certify to
the registered establishment that
manufactured, prepared, propagated,
compounded, or processed (which
includes, among other things,
repackaging and relabeling) the listed
drug that the drug listing submission
was made. Establishments must, within
5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a
listing for every drug or biological
product in commercial distribution at
that time. Private label distributors may
elect to submit to FDA a listing of every
drug product they place in commercial
distribution. Registered establishments
must submit to FDA drug product
listing for those private label
distributors who do not elect to submit
listing information.
Under § 207.25, product listing
information submitted to FDA by
domestic and foreign manufacturers
must, depending on the type of product
being listed, include any new drug
application number or biological
establishment license number, copies of
current labeling and a sampling of
advertisements, a quantitative listing of
the active ingredient for each drug or
biological product not subject to an
approved application or license, the
NDC number, and any drug imprinting
information.
In addition to the product listing
information required, FDA may also
require, under § 207.31, a copy of all
advertisements and a quantitative listing
of all ingredients for each listed drug or
biological product not subject to an
approved application or license; the
basis for a determination, by the
establishment, that a listed drug or
biological product is not subject to
marketing or licensing approval
requirements; and a list of certain drugs
or biological products containing a
particular ingredient. FDA may also
request, but not require, the submission
of a qualitative listing of the inactive
ingredients for all listed drugs or
biological products, and a quantitative
listing of the active ingredients for all
listed drugs or biological products
subject to an approved application or
license.
Under § 207.30, establishments must
update their product listing information
every June and December or, at the
discretion of the establishment, when
any change occurs. These updates must
include the following information: (1) A
listing of all drug or biological products
introduced for commercial distribution
that have not been included in any
previously submitted list; (2) all drug or
biological products formerly listed for
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15215
which commercial distribution has been
discontinued; (3) all drug or biological
products for which a notice of
discontinuance was submitted and for
which commercial distribution has been
resumed; and (4) any material change in
any information previously submitted.
No update is required if no changes
have occurred since the previously
submitted list.
Historically, drug establishment
registration and drug listing information
have been submitted in paper form
using Form FDA 2656 (Registration of
Drug Establishment/Labeler Code
Assignment), Form FDA 2657 (Drug
Product Listing), and Form FDA 2658
(Registered Establishments’ Report of
Private Label Distributors) (collectively
referred to as FDA Forms). Changes in
the FD&C Act resulting from enactment
of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85) (FDAAA) require that drug
establishment registration and drug
listing information be submitted
electronically unless a waiver is
granted. Before the enactment of
FDAAA, section 510(p) of the FD&C Act
expressly provided for electronic
submission of drug establishment
registration information upon a finding
that electronic receipt was feasible, and
section 510(j) of the FD&C Act provided
that drug listing information be
submitted in the form and manner
prescribed by FDA. Section 224 of
FDAAA, which amends section 510(p)
of the FD&C Act, now expressly,
requires electronic drug listing in
addition to drug establishment
registration. In certain cases, if it is
unreasonable to expect a person to
submit registration and listing
information electronically, FDA may
grant a waiver from the electronic
format requirement.
In the Federal Register of June 1, 2009
(74 FR 26248), FDA announced the
availability of a guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Drug Listing’’ (the 2009 guidance). The
document provides guidance to industry
on the statutory requirement to submit
electronically drug establishment
registration and drug listing
information. The guidance describes the
types of information to include for
purposes of drug establishment
registration and drug listing and how to
prepare and submit the information in
an electronic format (Structured Product
Labeling (SPL) files) that FDA can
process, review, and archive. In
addition to the information that
previously was collected on the FDA
Forms, the guidance addresses
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
electronic submission of other required
information as follows:
• For registered foreign drug
establishments, the name, address, and
telephone number of its U.S. agent
(§ 207.40(c));
• the name of each importer that is
known to the establishment (the U.S.
company or individual in the United
States that is an owner, consignee, or
recipient of the foreign establishment’s
drug that is imported into the United
States. An importer does not include the
consumer or patient who ultimately
purchases, receives, or is administered
the drug, unless the foreign
establishment ships the drug directly to
the consumer or the patient) (section
510(i)(1)(A) of the FD&C Act); and
• the name of each person who
imports or offers for import (the name
of each agent, broker, or other entity,
other than a carrier, that the foreign
drug establishment uses to facilitate the
import of their drug into the United
States) (section 510(i)(1)(A) of the FD&C
Act).
FDA also recommends the voluntary
submission of the following additional
information, when applicable:
• To facilitate correspondence
between foreign establishments and
FDA, the email address for the U.S.
agent, and the telephone number(s) and
email address for the importer and
person who imports or offers for import
their drug;
• a site-specific Data Universal
Numbering System number for each
entity (e.g., the registrant,
establishments, U.S. agent, importer);
• the NDC product code for the
source drug that is repacked or
relabeled;
• distinctive characteristics of certain
listed drugs, i.e., the flavor, the color,
and image of the actual solid dosage
form; and
• registrants may indicate that they
view as confidential the registrant’s
business relationship with an
establishment, or an inactive ingredient.
In addition to this collection of
information, there is an additional
burden for the following activities:
• preparing a standard operating
procedure (SOP) for the electronic
submission of drug establishment
registration and drug listing
information;
• creating the SPL file, including
accessing and reviewing the technical
specifications and instructional
documents provided by FDA (accessible
at https://www.fda.gov/oc/datacouncil/
spl.html);
• reviewing and selecting appropriate
terms and codes used to create the SPL
file (accessible at https://www.fda.gov/
oc/datacouncil/spl.html);
• obtaining the digital certificate used
with FDA’s electronic submission
gateway and uploading the SPL file for
submission (accessible at https://
www.fda.gov/esg/default.htm); and
• requests for waivers from the
electronic submission process as
described in the draft guidance.
When FDA published the 2009
guidance on submitting establishment
registration and drug listing information
in electronic format, the Agency also
amended its burden estimates for OMB
control number 0910–0045 to include
the additional burden for the collection
of information that had not been
submitted using the FDA forms, and to
create and upload the SPL file. The
amended burden estimates included the
one-time preparation of an SOP for
creating and uploading the SPL file.
Although most firms will already have
prepared an SOP for the electronic
submission of drug establishment
registration and drug listing
information, each year additional firms
will need to create an SOP. As provided
in Table 2 of this document, FDA
estimates that approximately 1,000
firms will have to expend a one-time
burden to prepare, review, and approve
an SOP, and the Agency estimates that
it will take 40 hours per recordkeeper to
create 1,000 new SOPs for a total of
40,000 hours.
In Tables 1 and 2, the information
collection requirements of the drug
establishment registration and drug
listing requirements have been grouped
according to the information collection
areas of the requirements.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
New registrations, including new labeler codes requests ...
Annual updates of registration information ..........................
New drug listings .................................................................
New listings for private label distributor ...............................
June and December updates of all drug listing information
Waiver requests ...................................................................
1,400
10,000
1,567
146
5,300
1
2
1
7
10.06
20
1
2,800
10,000
11,000
1,469
106,000
1
4.5
4.5
4.5
4.5
4.5
1
12,600
45,000
49,500
6,611
477,000
1
Total ..............................................................................
........................
........................
........................
........................
590,712
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity resulting from section 510(p) of the FD&C Act as
amended by FDAAA
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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One-time preparation of SOP ..............................................
SOP maintenance ................................................................
1,000
3,295
1
1
1,000
3,295
40
1
40,000
3,295
Total ..............................................................................
........................
........................
........................
........................
43,295
1 There
are no capital costs or operating and maintenance costs associated with the collection of information.
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06497 Filed 3–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1288]
Electronic Submission of Lot
Distribution Reports; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Electronic Submission of Lot
Distribution Reports; Guidance for
Industry.’’ The guidance document
provides information and
recommendations pertaining to the
electronic submission of lot distribution
reports for applicants with approved
biologics license applications (BLAs).
FDA recently published in the Federal
Register a final rule requiring that,
among other things, lot distribution
reports be submitted to FDA in an
electronic format that the Agency can
process, review, and archive. The
guidance announced in this notice
finalizes the draft guidance entitled
‘‘Guidance for Industry: Electronic
Submission of Lot Distribution Reports’’
dated August 2014, and is intended to
help licensed manufacturers of products
distributed under an approved BLA
(henceforth referred to as applicants)
comply with the final rule.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002 or
Division of Drug Information, Center for
Drug Evaluation and Research (CDER),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm.
2201, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
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SUMMARY:
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the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
J. Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911; or Jared Lantzy, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1116,
Silver Spring, MD 20993, email: esub@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Electronic
Submission of Lot Distribution Reports;
Guidance for Industry.’’ The guidance
provides information and
recommendations pertaining to the
electronic submission of lot distribution
reports. The guidance provides
information on how to electronically
submit lot distribution reports for
biological products under approved
BLAs for which CBER or CDER has
regulatory responsibility. The guidance
does not apply to any other biological
product.
FDA published in the Federal
Register of June 10, 2014 (79 FR 33072),
a final rule requiring electronic
submission of certain postmarketing
submissions. Among other things, under
this rule applicants are required to
submit biological lot distribution reports
to FDA in an electronic format that the
Agency can process, review, and
archive. The guidance is intended to
help applicants subject to lot
distribution reporting comply with the
final rule. Along with other information,
the guidance provides updated
information about the following: (1)
Structured Product Labeling standard
and vocabulary for electronic
submission of lot distribution reporting;
(2) additional resources such as
implementation guide, validation
procedures and links with further
information; and (3) procedures for
requesting temporary waivers from the
electronic submission requirement.
In the Federal Register of August 29,
2014 (79 FR 51576), FDA announced the
availability of the draft guidance
entitled ’’ Guidance for Industry:
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15217
Electronic Submission of Lot
Distribution Reports’’ dated August
2014. FDA published a correction notice
to correct the docket number in the
Federal Register of September 16, 2014
(79 FR 55497). FDA received a few
comments on the draft guidance and
those comments were considered as the
guidance was finalized. FDA is
finalizing the draft guidance with only
editorial changes. The guidance
announced in this notice finalizes the
draft guidance dated August 2014.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 600.81 and 600.90 have been
approved under 0910–0308.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
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]]>Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15214-15217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06497]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0742]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the requirements for drug
establishment registration and drug listing.
DATES: Submit either electronic or written comments on the collection
of information by May 22, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002; PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207 (OMB Control Number 0910-0045)--Extension
Requirements for drug establishment registration and drug listing
are set forth in section 510 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health
Service Act (42 U.S.C.
[[Page 15215]]
262), and part 207 (21 CFR part 207). Fundamental to FDA's mission to
protect the public health is the collection of this information, which
is used for important activities such as postmarket surveillance for
serious adverse drug reactions, inspection of drug manufacturing and
processing facilities, and monitoring of drug products imported into
the United States. Comprehensive, accurate, and up to date information
is critical to conducting these activities with efficiency and
effectiveness.
Under section 510 of the FD&C Act, FDA is authorized to establish a
system for registration of producers of drugs and for listing of drugs
in commercial distribution. To implement section 510 of the FD&C Act,
FDA issued part 207. Under current Sec. 207.20, manufacturers,
repackers, and relabelers that engage in the manufacture, preparation,
propagation, compounding, or processing of human or veterinary drugs
and biological products, including bulk drug substances and bulk drug
substances for prescription compounding, and drug premixes as well as
finished dosage forms, whether prescription or over-the-counter, are
required to register their establishment. In addition, manufacturers,
repackers, and relabelers are required to submit a listing of every
drug or biological product in commercial distribution. Owners or
operators of establishments that distribute under their own label or
trade name a drug product manufactured by a registered establishment
are not required either to register or list. However, distributors may
elect to submit drug listing information in lieu of the registered
establishment that manufactures the drug product. Foreign drug
establishments must also comply with the establishment registration and
product listing requirements if they import or offer for import their
products into the United States.
Under current Sec. 207.21, establishments, both domestic and
foreign, must register with FDA within 5 days after beginning the
manufacture of drugs or biologicals, or within 5 days after the
submission of a drug application or biological license application. In
addition, establishments must register annually. Changes in individual
ownership, corporate or partnership structure, location, or drug
handling activity must be submitted as amendments to registration under
current Sec. 207.26 within 5 days of such changes. Under Sec.
207.20(b), private label distributors may request their own labeler
code and elect to submit drug listing information to FDA. In such
instances, at the time of submitting or updating drug listing
information, private label distributors must certify to the registered
establishment that manufactured, prepared, propagated, compounded, or
processed (which includes, among other things, repackaging and
relabeling) the listed drug that the drug listing submission was made.
Establishments must, within 5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a listing for every drug or
biological product in commercial distribution at that time. Private
label distributors may elect to submit to FDA a listing of every drug
product they place in commercial distribution. Registered
establishments must submit to FDA drug product listing for those
private label distributors who do not elect to submit listing
information.
Under Sec. 207.25, product listing information submitted to FDA by
domestic and foreign manufacturers must, depending on the type of
product being listed, include any new drug application number or
biological establishment license number, copies of current labeling and
a sampling of advertisements, a quantitative listing of the active
ingredient for each drug or biological product not subject to an
approved application or license, the NDC number, and any drug
imprinting information.
In addition to the product listing information required, FDA may
also require, under Sec. 207.31, a copy of all advertisements and a
quantitative listing of all ingredients for each listed drug or
biological product not subject to an approved application or license;
the basis for a determination, by the establishment, that a listed drug
or biological product is not subject to marketing or licensing approval
requirements; and a list of certain drugs or biological products
containing a particular ingredient. FDA may also request, but not
require, the submission of a qualitative listing of the inactive
ingredients for all listed drugs or biological products, and a
quantitative listing of the active ingredients for all listed drugs or
biological products subject to an approved application or license.
Under Sec. 207.30, establishments must update their product
listing information every June and December or, at the discretion of
the establishment, when any change occurs. These updates must include
the following information: (1) A listing of all drug or biological
products introduced for commercial distribution that have not been
included in any previously submitted list; (2) all drug or biological
products formerly listed for which commercial distribution has been
discontinued; (3) all drug or biological products for which a notice of
discontinuance was submitted and for which commercial distribution has
been resumed; and (4) any material change in any information previously
submitted. No update is required if no changes have occurred since the
previously submitted list.
Historically, drug establishment registration and drug listing
information have been submitted in paper form using Form FDA 2656
(Registration of Drug Establishment/Labeler Code Assignment), Form FDA
2657 (Drug Product Listing), and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors) (collectively
referred to as FDA Forms). Changes in the FD&C Act resulting from
enactment of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) (FDAAA) require that drug establishment registration
and drug listing information be submitted electronically unless a
waiver is granted. Before the enactment of FDAAA, section 510(p) of the
FD&C Act expressly provided for electronic submission of drug
establishment registration information upon a finding that electronic
receipt was feasible, and section 510(j) of the FD&C Act provided that
drug listing information be submitted in the form and manner prescribed
by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C
Act, now expressly, requires electronic drug listing in addition to
drug establishment registration. In certain cases, if it is
unreasonable to expect a person to submit registration and listing
information electronically, FDA may grant a waiver from the electronic
format requirement.
In the Federal Register of June 1, 2009 (74 FR 26248), FDA
announced the availability of a guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing'' (the 2009 guidance). The
document provides guidance to industry on the statutory requirement to
submit electronically drug establishment registration and drug listing
information. The guidance describes the types of information to include
for purposes of drug establishment registration and drug listing and
how to prepare and submit the information in an electronic format
(Structured Product Labeling (SPL) files) that FDA can process, review,
and archive. In addition to the information that previously was
collected on the FDA Forms, the guidance addresses
[[Page 15216]]
electronic submission of other required information as follows:
For registered foreign drug establishments, the name,
address, and telephone number of its U.S. agent (Sec. 207.40(c));
the name of each importer that is known to the
establishment (the U.S. company or individual in the United States that
is an owner, consignee, or recipient of the foreign establishment's
drug that is imported into the United States. An importer does not
include the consumer or patient who ultimately purchases, receives, or
is administered the drug, unless the foreign establishment ships the
drug directly to the consumer or the patient) (section 510(i)(1)(A) of
the FD&C Act); and
the name of each person who imports or offers for import
(the name of each agent, broker, or other entity, other than a carrier,
that the foreign drug establishment uses to facilitate the import of
their drug into the United States) (section 510(i)(1)(A) of the FD&C
Act).
FDA also recommends the voluntary submission of the following
additional information, when applicable:
To facilitate correspondence between foreign
establishments and FDA, the email address for the U.S. agent, and the
telephone number(s) and email address for the importer and person who
imports or offers for import their drug;
a site-specific Data Universal Numbering System number for
each entity (e.g., the registrant, establishments, U.S. agent,
importer);
the NDC product code for the source drug that is repacked
or relabeled;
distinctive characteristics of certain listed drugs, i.e.,
the flavor, the color, and image of the actual solid dosage form; and
registrants may indicate that they view as confidential
the registrant's business relationship with an establishment, or an
inactive ingredient.
In addition to this collection of information, there is an
additional burden for the following activities:
preparing a standard operating procedure (SOP) for the
electronic submission of drug establishment registration and drug
listing information;
creating the SPL file, including accessing and reviewing
the technical specifications and instructional documents provided by
FDA (accessible at https://www.fda.gov/oc/datacouncil/spl.html);
reviewing and selecting appropriate terms and codes used
to create the SPL file (accessible at https://www.fda.gov/oc/datacouncil/spl.html);
obtaining the digital certificate used with FDA's
electronic submission gateway and uploading the SPL file for submission
(accessible at https://www.fda.gov/esg/default.htm); and
requests for waivers from the electronic submission
process as described in the draft guidance.
When FDA published the 2009 guidance on submitting establishment
registration and drug listing information in electronic format, the
Agency also amended its burden estimates for OMB control number 0910-
0045 to include the additional burden for the collection of information
that had not been submitted using the FDA forms, and to create and
upload the SPL file. The amended burden estimates included the one-time
preparation of an SOP for creating and uploading the SPL file. Although
most firms will already have prepared an SOP for the electronic
submission of drug establishment registration and drug listing
information, each year additional firms will need to create an SOP. As
provided in Table 2 of this document, FDA estimates that approximately
1,000 firms will have to expend a one-time burden to prepare, review,
and approve an SOP, and the Agency estimates that it will take 40 hours
per recordkeeper to create 1,000 new SOPs for a total of 40,000 hours.
In Tables 1 and 2, the information collection requirements of the
drug establishment registration and drug listing requirements have been
grouped according to the information collection areas of the
requirements.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
New registrations, including new 1,400 2 2,800 4.5 12,600
labeler codes requests.........
Annual updates of registration 10,000 1 10,000 4.5 45,000
information....................
New drug listings............... 1,567 7 11,000 4.5 49,500
New listings for private label 146 10.06 1,469 4.5 6,611
distributor....................
June and December updates of all 5,300 20 106,000 4.5 477,000
drug listing information.......
Waiver requests................. 1 1 1 1 1
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Total....................... .............. .............. .............. .............. 590,712
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Activity resulting from section Number of Average
510(p) of the FD&C Act as Number of records per Total annual burden per Total hours
amended by FDAAA recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
One-time preparation of SOP..... 1,000 1 1,000 40 40,000
SOP maintenance................. 3,295 1 3,295 1 3,295
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Total....................... .............. .............. .............. .............. 43,295
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.
[[Page 15217]]
Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06497 Filed 3-20-15; 8:45 am]
BILLING CODE 4164-01-P
