Draft Guidance for Industry on Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act; Availability, 40109-40111 [2014-16238]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 301–
796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product HORIZANT
(gabapentin enacarbil). HORIZANT is
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Jkt 232001
indicated for the treatment of moderate
to severe primary Restless Legs
Syndrome in adults. Subsequent to this
approval, the USPTO received a patent
term restoration application for
HORIZANT (U.S. Patent No. 6,818,787)
from XenoPort, Inc., and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 2, 2012, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of HORIZANT
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
HORIZANT is 2,277 days. Of this time,
1,459 days occurred during the testing
phase of the regulatory review period,
while 818 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: January
12, 2005. FDA has verified the
applicant’s claim that the date the
investigational new drug application
became effective was on January 12,
2005.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: January 9, 2009.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Horizant (NDA 22–399) was submitted
on January 9, 2009.
3. The date the application was
approved: April 6, 2011. FDA has
verified the applicant’s claim that NDA
22–399 was approved on April 6, 2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 882 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by September 9,
2014. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by January 7, 2015. To meet its
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40109
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. 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. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16237 Filed 7–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0829]
Draft Guidance for Industry on
Reporting Drug Sample Information
Under Section 6004 of the Affordable
Care Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Reporting Drug
Sample Information Under Section 6004
of the Affordable Care Act.’’ On March
23, 2010, the Patient Protection and
Affordable Care Act (ACA) was signed
into law. The Secretary of Health and
Human Services has delegated authority
to FDA to issue guidance to identify the
information to be submitted under
section 6004 and oversee and make
arrangements for the collection of such
information. FDA is issuing this draft
guidance to provide information to
assist persons submitting drug sample
information under ACA section 6004,
and to advise industry of an updated
compliance policy. This draft guidance
revises the draft compliance policy
guide issued on April 3, 2012.
SUMMARY:
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40110
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 9,
2014. Submit either electronic or
written comments concerning the
proposed collection of information by
September 9, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communications, Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
floor, Rm. 4147, Silver Spring, MD
20993, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft 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:
Karen Rothschild, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4282,
Silver Spring, MD 20903, 301–796–
3689, or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20903, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
DATES:
tkelley on DSK3SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Reporting Drug Sample Information
Under Section 6004 of the Affordable
Care Act.’’ On March 23, 2010, the ACA
was signed into law. Among its many
provisions, section 6004 of the ACA
amended the Social Security Act (SSA)
by adding section 1128H (42 U.S.C.
1320a–7i). This new section required
the submission of certain drug sample
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Jkt 232001
information to FDA not later than April
1 of each year, beginning April 1, 2012.
In particular, section 6004 requires
reporting about drug sample requests
and distributions from manufacturers
and authorized distributors of record
(ADRs) of applicable drugs (prescription
drugs), which are defined in the ACA as
drugs subject to section 503(b) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 353(b)) for
which payment is available under Title
XVIII or the SSA or a State plan under
Title XIX or XXI of the SSA (or a waiver
of such plan). (See 42 U.S.C. 1320a–
7i(b)(1).) The Secretary has delegated
authority to FDA to issue guidance
identifying the information to be
submitted under section 6004, and to
oversee and arrange for the collection of
such information.
Section 6004 is not part of the
Prescription Drug Marketing Act
(PDMA) but must be read together with
that act. Two of the terms used in
section 6004 are defined by reference to
the PDMA. In addition, the PDMA and
its implementing regulations at 21 CFR
part 203, subpart D (beginning at
§ 203.30 (21 CFR 203.30)) require the
collection and maintenance of
information that must be submitted
under section 6004. For example,
§ 203.38(b) requires that a manufacturer
or ADR maintain records of drug sample
distribution for all samples distributed
under section 503(d)(2) or 503(d)(3) of
the FD&C Act that are sufficient to
permit tracking of sample units to the
point of the licensed practitioner. Under
section 6004, manufacturers and ADRs
must now submit much of the same
information, aggregated as specified, to
FDA.
Another example of how the PDMA
and section 6004 are complementary is
that the PDMA requires manufacturers
and ADRs to collect signatures to ensure
that drug samples are distributed on the
request of authorized persons and that
their receipt is accounted for by persons
authorized to take responsibility for
them. The purpose of this requirement
is to ensure a tight chain of custody,
which is why no person other than the
practitioner or a specified designee (i.e.,
not a common carrier) may sign for
receipt of drug samples. The
requirement in section 6004 to report
drug sample requests and distributions
for each drug, aggregated by signature,
is to ensure that FDA has the
information needed to demonstrate
compliance with this important PDMA
provision.
In the Federal Register of April 3,
2012 (77 FR 20025), FDA issued a draft
guidance for industry entitled
‘‘Compliance Policy on Reporting Drug
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Sfmt 4703
Sample Distribution Information Under
the Affordable Care Act,’’ concerning
section 6004. In that draft guidance,
FDA explained that the Electronic
Submissions Gateway (the Gateway)
was available and ready to receive
submissions of drug sample information
as required by section 6004. That
guidance also stated FDA’s temporary
compliance policy with regard to those
submissions, and FDA’s intent to issue
subsequent guidance with details to
better assist persons submitting drug
sample information under section 6004
and to advise industry of an updated
compliance policy. FDA received
comments on the guidance and on the
use of the Gateway to submit the drug
sample information required by section
6004. After carefully considering
submitted comments, FDA has revised
the draft guidance, adding more
substantive information and announcing
an updated compliance policy, and is
reissuing it as a draft to facilitate public
comment.
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 reporting drug sample information
under section 6004 of the ACA. 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
Under the Paperwork Reduction Act
of 1995 (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 that 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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, FDA invites comments on the
following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
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Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under section 6004 of the ACA,
manufacturers and ADRs must submit
the following drug sample information
to FDA each year: (1) The identity and
quantity of drug samples requested; (2)
the identity and quantity of drug
samples distributed; (3) the name,
address, professional designation, and
signature of any person who makes or
signs for the request; and (4) any other
category of information determined
appropriate by the Secretary. The draft
guidance clarifies the specific
information that should be submitted
under this provision and the manner in
which that information should be
submitted.
The draft guidance states that FDA’s
Gateway became available for drug
sample reporting under 6004 in March
2012, and that FDA intends to continue
the use of the Gateway for this purpose.
The Gateway accepts submissions in
XML format. Technical specifications
for the data type and size for submitting
each of the items listed previously may
be found in the ACA Industry
Submission Specifications User Guide,
available at: https://www.fda.gov/down
loads/Drugs/GuidanceCompliance
RegulatoryInformation/UCM297610.pdf.
The Gateway requests that
manufacturers and ADRs provide the
following information, which is
sufficient to comply with the reporting
requirements set forth in section 6004 of
the ACA:
• The year the sample was distributed
to the provider;
• the type of business (i.e., either
manufacturer or distributor);
• the business name of the
manufacturer or distributor that
distributed the drug sample;
• the trade name and dosage of the
drug sample distributed;
• the total quantity of the drug
requested by the practitioner during the
calendar year;
• the total quantity of the drug
distributed to the practitioner during the
calendar year;
• the first name, last name, and
middle initial of the practitioner;
• the practitioner’s designation (i.e.,
M.D., D.O., P.A., or more);
• the street number, street name, city,
state, and ZIP code address of the
practitioner;
• an electronic affirmation that a
signed written request for drug samples
was received by the manufacturer or
ADR from the licensed practitioner and
is available to FDA upon request;
• an electronic affirmation that a
signature of the requesting practitioner,
or appropriate designee, acknowledging
receipt of drug samples has been
received by the manufacturer or ADR
and is available to FDA upon request;
• the first name, last name, and
middle initial of a practitioner’s
designee; and
• the address, including street
number, street, city, state, and ZIP code
of the designee.
Based on the current number of
submissions since the enactment of
section 6004 of the ACA, we estimate
that annually a total of approximately
120 to 250 manufacturers or ADRs
(‘‘number of respondents’’ in table 1)
will submit the drug sample information
specified, resulting in approximately
120 to 250 annual submissions (‘‘total
annual responses’’ in table 1). We also
estimate that preparing and submitting
this information to FDA will take
approximately 500 to 600 hours for each
manufacturer or ADR (‘‘hours per
response’’ in table 1). We base the
burden hour estimate on information we
obtained from two manufacturers who
have submitted the drug sample
information since the enactment of
section 6004 of the ACA. We are using
the upper end of these ranges to
calculate the burden in table 1, and the
burden hour estimate includes the time
that may be needed to submit any
followup or additional information to
FDA. In addition, for purposes of this
notice, FDA assumes that only
manufacturers will submit the required
information on behalf of all samples
distributed, thereby excluding the need
for ADRs to do so.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Section 6004 of the ACA
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Submission of drug sample information ..............................
250
1
250
600
150,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Comments
IV. Electronic Access
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.
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16238 Filed 7–10–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0902]
Draft Guidance for Industry on
Abbreviated New Drug Application
Submissions; Amendments and Easily
Correctable Deficiencies Under the
Generic Drug User Fee Amendments;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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11JYN1
]]>Agencies
[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40109-40111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0829]
Draft Guidance for Industry on Reporting Drug Sample Information
Under Section 6004 of the Affordable Care Act; 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 ``Reporting Drug
Sample Information Under Section 6004 of the Affordable Care Act.'' On
March 23, 2010, the Patient Protection and Affordable Care Act (ACA)
was signed into law. The Secretary of Health and Human Services has
delegated authority to FDA to issue guidance to identify the
information to be submitted under section 6004 and oversee and make
arrangements for the collection of such information. FDA is issuing
this draft guidance to provide information to assist persons submitting
drug sample information under ACA section 6004, and to advise industry
of an updated compliance policy. This draft guidance revises the draft
compliance policy guide issued on April 3, 2012.
[[Page 40110]]
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 comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 9, 2014. Submit either electronic or written
comments concerning the proposed collection of information by September
9, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communications, Division of Drug Information,
Center for Drug Evaluation and Research, Food and Drug Administration,
10001 New Hampshire Ave., Hillandale Bldg., 4th floor, Rm. 4147, Silver
Spring, MD 20993, or the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. The draft guidance may also be obtained
by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft 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: Karen Rothschild, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4282, Silver Spring, MD 20903, 301-796-
3689, or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20903, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Reporting Drug Sample Information Under Section 6004 of the
Affordable Care Act.'' On March 23, 2010, the ACA was signed into law.
Among its many provisions, section 6004 of the ACA amended the Social
Security Act (SSA) by adding section 1128H (42 U.S.C. 1320a-7i). This
new section required the submission of certain drug sample information
to FDA not later than April 1 of each year, beginning April 1, 2012.
In particular, section 6004 requires reporting about drug sample
requests and distributions from manufacturers and authorized
distributors of record (ADRs) of applicable drugs (prescription drugs),
which are defined in the ACA as drugs subject to section 503(b) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353(b))
for which payment is available under Title XVIII or the SSA or a State
plan under Title XIX or XXI of the SSA (or a waiver of such plan). (See
42 U.S.C. 1320a-7i(b)(1).) The Secretary has delegated authority to FDA
to issue guidance identifying the information to be submitted under
section 6004, and to oversee and arrange for the collection of such
information.
Section 6004 is not part of the Prescription Drug Marketing Act
(PDMA) but must be read together with that act. Two of the terms used
in section 6004 are defined by reference to the PDMA. In addition, the
PDMA and its implementing regulations at 21 CFR part 203, subpart D
(beginning at Sec. 203.30 (21 CFR 203.30)) require the collection and
maintenance of information that must be submitted under section 6004.
For example, Sec. 203.38(b) requires that a manufacturer or ADR
maintain records of drug sample distribution for all samples
distributed under section 503(d)(2) or 503(d)(3) of the FD&C Act that
are sufficient to permit tracking of sample units to the point of the
licensed practitioner. Under section 6004, manufacturers and ADRs must
now submit much of the same information, aggregated as specified, to
FDA.
Another example of how the PDMA and section 6004 are complementary
is that the PDMA requires manufacturers and ADRs to collect signatures
to ensure that drug samples are distributed on the request of
authorized persons and that their receipt is accounted for by persons
authorized to take responsibility for them. The purpose of this
requirement is to ensure a tight chain of custody, which is why no
person other than the practitioner or a specified designee (i.e., not a
common carrier) may sign for receipt of drug samples. The requirement
in section 6004 to report drug sample requests and distributions for
each drug, aggregated by signature, is to ensure that FDA has the
information needed to demonstrate compliance with this important PDMA
provision.
In the Federal Register of April 3, 2012 (77 FR 20025), FDA issued
a draft guidance for industry entitled ``Compliance Policy on Reporting
Drug Sample Distribution Information Under the Affordable Care Act,''
concerning section 6004. In that draft guidance, FDA explained that the
Electronic Submissions Gateway (the Gateway) was available and ready to
receive submissions of drug sample information as required by section
6004. That guidance also stated FDA's temporary compliance policy with
regard to those submissions, and FDA's intent to issue subsequent
guidance with details to better assist persons submitting drug sample
information under section 6004 and to advise industry of an updated
compliance policy. FDA received comments on the guidance and on the use
of the Gateway to submit the drug sample information required by
section 6004. After carefully considering submitted comments, FDA has
revised the draft guidance, adding more substantive information and
announcing an updated compliance policy, and is reissuing it as a draft
to facilitate public comment.
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 reporting
drug sample information under section 6004 of the ACA. 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
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of
[[Page 40111]]
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimated burden of the proposed
information collected, including the validity of the methodology and
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information collected; and (4) ways to minimize the burden of
information collected on the respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Under section 6004 of the ACA, manufacturers and ADRs must submit
the following drug sample information to FDA each year: (1) The
identity and quantity of drug samples requested; (2) the identity and
quantity of drug samples distributed; (3) the name, address,
professional designation, and signature of any person who makes or
signs for the request; and (4) any other category of information
determined appropriate by the Secretary. The draft guidance clarifies
the specific information that should be submitted under this provision
and the manner in which that information should be submitted.
The draft guidance states that FDA's Gateway became available for
drug sample reporting under 6004 in March 2012, and that FDA intends to
continue the use of the Gateway for this purpose. The Gateway accepts
submissions in XML format. Technical specifications for the data type
and size for submitting each of the items listed previously may be
found in the ACA Industry Submission Specifications User Guide,
available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM297610.pdf.
The Gateway requests that manufacturers and ADRs provide the
following information, which is sufficient to comply with the reporting
requirements set forth in section 6004 of the ACA:
The year the sample was distributed to the provider;
the type of business (i.e., either manufacturer or
distributor);
the business name of the manufacturer or distributor that
distributed the drug sample;
the trade name and dosage of the drug sample distributed;
the total quantity of the drug requested by the
practitioner during the calendar year;
the total quantity of the drug distributed to the
practitioner during the calendar year;
the first name, last name, and middle initial of the
practitioner;
the practitioner's designation (i.e., M.D., D.O., P.A., or
more);
the street number, street name, city, state, and ZIP code
address of the practitioner;
an electronic affirmation that a signed written request
for drug samples was received by the manufacturer or ADR from the
licensed practitioner and is available to FDA upon request;
an electronic affirmation that a signature of the
requesting practitioner, or appropriate designee, acknowledging receipt
of drug samples has been received by the manufacturer or ADR and is
available to FDA upon request;
the first name, last name, and middle initial of a
practitioner's designee; and
the address, including street number, street, city, state,
and ZIP code of the designee.
Based on the current number of submissions since the enactment of
section 6004 of the ACA, we estimate that annually a total of
approximately 120 to 250 manufacturers or ADRs (``number of
respondents'' in table 1) will submit the drug sample information
specified, resulting in approximately 120 to 250 annual submissions
(``total annual responses'' in table 1). We also estimate that
preparing and submitting this information to FDA will take
approximately 500 to 600 hours for each manufacturer or ADR (``hours
per response'' in table 1). We base the burden hour estimate on
information we obtained from two manufacturers who have submitted the
drug sample information since the enactment of section 6004 of the ACA.
We are using the upper end of these ranges to calculate the burden in
table 1, and the burden hour estimate includes the time that may be
needed to submit any followup or additional information to FDA. In
addition, for purposes of this notice, FDA assumes that only
manufacturers will submit the required information on behalf of all
samples distributed, thereby excluding the need for ADRs to do so.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Section 6004 of the ACA Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of drug sample information.............................. 250 1 250 600 150,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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 document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16238 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P
