
[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]


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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Draft Guidance for Industry on Reporting Drug Sample Information 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.

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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availability of a draft guidance for industry entitled ``Reporting Drug 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this draft guidance to provide information to assist persons submitting 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 This draft guidance revises the draft 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.

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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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 9, 2014.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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communications, Division of Drug Information, 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 The draft guidance may also be obtained 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 http://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

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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: http://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
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Submission of drug sample information..............................             250                1              250              600          150,000
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\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 http://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 http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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


