
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37622-37625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0742]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Registration of 
Producers of Drugs and Listing of Drugs in Commercial Distribution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
31, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0045. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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. 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

[[Page 37623]]

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 national drug code (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 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;

[[Page 37624]]

     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 http://www.fda.gov/oc/datacouncil/spl.html);
     reviewing and selecting appropriate terms and codes used 
to create the SPL file (accessible at http://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 http://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, 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 the Federal Register of March 23, 2015 (80 FR 15214), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment.
    The comment noted that under Sec.  207.20(a), manufacturers, 
repackers, and relabelers are required to register their establishment 
and submit a listing of every drug or biological product in commercial 
distribution. Under Sec.  207.20(b), 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 but may elect to submit drug 
listing information in lieu of the registered establishment that 
manufactures the drug product. The comment said that although the 
burden of listing private label drugs rests on the manufacturer, the 
standard industry practice has been to submit two separate listings 
under different marketing categories. The comment said that these 
listings are submitted either by the private label distributor or by 
the manufacturer and ``in order for the necessary information to be 
provided to FDA (all Offices and Centers) both listings are 
necessary.'' The comment also recommended that all drug listings should 
include the marketing category of the drug.
    FDA Response: Under section 510 of the FD&C Act and part 207, 
contract manufacturers (registered establishments) are required to list 
their products with FDA under their own labeler code. To properly 
identify such a listing, contract manufacturers should list products 
manufactured for a private label distributor by using one of following 
marketing categories: (1) Approved Drug Product Manufactured 
Exclusively For Private Label Distributor; (2) OTC Monograph Drug 
Product Manufactured Exclusively For Private Label Distributor; (3) 
Unapproved Drug Product Manufactured Exclusively For Private Label 
Distributor. Contract manufacturers may also include the private label 
distributor's labeling with the listing submission.
    Additionally, Sec.  207.20(b) requires that the private label 
distributor have its product listed under its own labeler code (using 
whatever marketing category is appropriate to the finished product 
(e.g., NDA, OTC Monograph, Unapproved Drug)). The private label 
distributor may elect to do this on its own. If the private label 
distributor elects not to do this, then the responsibility for 
submitting the additional listing falls on the registered establishment 
(the contract manufacturer).
    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\
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                                                                                 Number of
                        Activity                             Number of         responses per       Total annual    Average burden per     Total hours
                                                            respondents         respondent          responses           response
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New registrations, including new labeler codes requests              1,400                2                 2,800                4.5              12,600
Annual updates of registration information.............             10,000                1                10,000                4.5              45,000
New drug listings......................................              1,567                7                11,000                4.5              49,500
New listings for private label distributor.............                146               10.06              1,469                4.5               6,611
June and December updates of all drug listing                        5,300               20               106,000                4.5             477,000
 information...........................................
Waiver requests........................................                  1                1                     1                1                     1
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    Total..............................................  .................  ..................  .................  ..................            590,712
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 37625]]


                                                    Table 2--Estimated Annual Recordkeeping Burden 1
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Activity resulting from Section 510(p) of the FD&C Act as      Number of      Number of records     Total annual      Average burden
                     amended by FDAAA                        recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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One-time preparation of SOP..............................              1,000                  1              1,000                 40             40,000
SOP maintenance..........................................              3,295                  1              3,295                  1              3,295
    Total................................................             43,295
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\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.


    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16129 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-P


