Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 33934-33938 [2018-15298]
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33934
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
FEDERAL RETIREMENT THRIFT
INVESTMENT BOARD
Sunshine Act; Notice of Meeting July
24, 2018, Telephonic, 12:00 p.m., 10th
Floor Board Meeting Room, 77 K Street
NE, Washington, DC 20002
Dated: July 16, 2018.
Dharmesh Vashee,
Deputy General Counsel, Federal Retirement
Thrift Investment Board.
[FR Doc. 2018–15433 Filed 7–16–18; 4:15 pm]
BILLING CODE 6760–01–P
Agenda
FEDERAL RETIREMENT THRIFT INVESTMENT
BOARD MEMBER MEETING STATUS: All
parts will be open to the public.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
MATTERS TO BE CONSIDERED:
Administration for Children and
Families
Open Session
[OMB NO.: 0970–0383]
1. Approval of the Minutes for the June
25, 2018 Board Member Meeting
2. Monthly Reports
(a) Participant Activity
(b) Legislative Report
3. Quarterly Reports
(c) Investment Performance
(d) Budget Review
(e) Audit Status
4. Enterprise Risk Management Update
5. IT Update
CONTACT PERSON FOR MORE INFORMATION:
Kimberly Weaver, Director, Office of
External Affairs, (202) 942–1640.
Submission for OMB Review;
Comment Request; Evaluation of the
Transitional Living Program (TLP)—
Extension
Description:
The Family and Youth Services
Bureau (FYSB) and the Office of
Planning, Research, Evaluation (OPRE)
in the Administration for Children and
Families (ACF) are requesting to
continue collecting data as part of a
currently approved information
collection (OMB No. 0970–0383). The
purpose is to continue baseline data
collection at study enrollment and
follow-up data collection for the
Evaluation of the Transitional Living
Program (TLP). The TLP evaluation was
designed to examine the effects of
FYSB’s Transitional Living Program on
runaway and homeless youth, focusing
on such outcomes as housing and
homelessness, education or training,
employment, social connections, socioemotional well-being, and risk
behaviors.
Data collection will include three
primary surveys: (1) A survey
administered at the time of TLP
enrollment (baseline), (2) a survey
administered 6 months after enrollment,
which will collect information on shortterms outcomes; and (3) a survey
administered at 12 months, which will
collect information on longer-term
outcomes.’’ Participants will be enrolled
through the TLP study sites.
Respondents: Runaway and homeless
youth ages 16 to 22 who agree to
participate in the study upon
enrollment into one of the TLP study
sites.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Total number
of respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
600
600
600
200
200
200
1
1
1
0.62
0.61
0.61
124
122
122
Estimated Total Burden Hours .....................................
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Young Adult Baseline Survey ..............................................
Young Adult 6-Month Follow Up Survey .............................
Young Adult 12-Month Follow Up Survey ...........................
........................
........................
........................
........................
368
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget
Paperwork Reduction Project
Email: OIRA_SUBMISSION@
OMB.EOP.GOV
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Attn: Desk Officer for the
Administration for Children and
Families
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–15307 Filed 7–17–18; 8:45 am]
BILLING CODE 4184–33–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:
PO 00000
Notice.
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The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each 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 information collection for
drug establishment registration and
product listing.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by September 17, 2018.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 17,
ADDRESSES:
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Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 17, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0742 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
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‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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
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33935
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
This information collection supports
FDA’s drug establishment registration
and listing regulations and associated
guidance intended to assist respondents
in this regard. 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), and
section 351 of the Public Health Service
Act (42 U.S.C. 262). Section 224 of the
Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85) amended section 510(p) of the FD&C
Act to require electronic drug
establishment registration and drug
listing. Regulations implementing these
provisions are established under 21 CFR
part 207. Except as provided in § 207.65,
all information submitted must be
transmitted to FDA in electronic format
by using our electronic drug registration
and listing system, in a form that we can
process, review, and archive.
Establishment registration information
helps FDA identify who is
manufacturing, repacking, relabeling,
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Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
and salvaging drugs and where those
operations are performed. Drug listing
information gives FDA a current
inventory of drugs manufactured,
repacked, relabeled, or salvaged for
commercial distribution. Both types of
information facilitate implementation
and enforcement of the FD&C Act and
are used for many important public
health purposes.
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Registration Under Part 207
Unless otherwise exempt under
section 510(g) of the FD&C Act or
§ 207.13, all manufacturers, repackers,
relabelers, and salvagers must register
each domestic establishment that
manufactures, repacks, relabels, or
salvages a drug, or an animal feed
bearing or containing a new animal
drug, and each foreign establishment
that manufactures, repacks, relabels, or
salvages a drug, or an animal feed
bearing or containing a new animal
drug, that is imported or offered for
import into the United States. When
operations are conducted at more than
one establishment and common
ownership and control among all the
establishments exists, the parent,
subsidiary, or affiliate company may
submit registration information for all
establishments.
Private label distributors who do not
also manufacture, repack, relabel, or
salvage drugs are not required to register
under part 207. FDA will accept
registration or listing information
submitted by a private label distributor
only if it is acting as an authorized agent
for and submitting information that
pertains to an establishment that
manufactures, repacks, relabels, or
salvages drugs.
Under § 207.21, domestic
manufacturers, domestic repackers,
domestic relabelers, and domestic drug
product salvagers must complete initial
registration of each establishment no
later than 5 calendar days after
beginning to manufacture, repack,
relabel, or salvage a drug. In addition,
foreign manufacturers, foreign
repackers, foreign relabelers, and foreign
drug product salvagers must register
each establishment before the drug is
imported or offered for import into the
United States.
The information that must be
provided to FDA for registration is
described in § 207.25 and includes the
following: (1) Name of the owner or
operator of each establishment; if a
partnership, the name of each partner; if
a corporation, the name of each
corporate officer and director, and the
place of incorporation; (2) each
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establishment’s name, physical address,
and telephone number(s); (3) all name(s)
of the establishment, including names
under which the establishment
conducts business or names by which
the establishment is known; (4)
registration number of each
establishment, if previously assigned by
FDA; (5) a Unique Facility Identifier in
accordance with the system specified
under section 510 of the FD&C Act; (6)
all types of operations performed at
each establishment; (7) name, mailing
address, telephone number, and email
address of the official contact for the
establishment, as provided in
§ 207.69(a); and (8) additionally, with
respect to foreign establishments subject
to registration, the name, mailing
address, telephone number, and email
address must be provided for: (a) The
U.S. agent, as provided in § 207.69(b);
(b) each importer in the United States of
drugs manufactured, repacked,
relabeled, or salvaged at the
establishment that is known to the
establishment; and (c) each person who
imports or offers for import such drug
to the United States.
Registrants must update their
registration information as prescribed
under § 207.29.
National Drug Code (NDC)
The NDC for a drug is a numeric code.
Each finished drug product or
unfinished drug subject to the listing
requirements of part 207 must have a
unique NDC to identify its labeler,
product, and package size and type. The
format of an NDC is described under
§ 207.33.
Under § 207.35, registrants must
notify us of a change in any of the drug
characteristics (except certain
identifying information) for an NDC in
§ 207.33, and assign a new product code
and package code for that drug.
Listing Under Part 207
Under § 207.41, registrants must list
each drug that it manufactures, repacks,
relabels, or salvages for commercial
distribution. Each domestic registrant
must list each such drug regardless of
whether the drug enters interstate
commerce. When operations are
conducted at more than one
establishment, and common ownership
and control exists among all the
establishments, the parent, subsidiary,
or affiliate company may submit listing
information for any drug manufactured,
repacked, relabeled, or salvaged at any
such establishment. A drug
manufactured, repacked, or relabeled for
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private label distribution must be listed
in accordance with the requirements.
Registrants must provide listing
information for each drug in accordance
with the listing requirements described
in §§ 207.49, 207.53, and 207.54 that
correspond to the activity or activities
they engage in for that drug. For both
animal and human drugs, each
registrant must list each drug it
manufactures, repacks, or relabels for
commercial distribution under the trade
name or label of a private label
distributor using an NDC that includes
such private label distributor’s labeler
code.
Additionally, in the case of human
drugs, each registrant must list each
human drug it manufactures, repacks, or
relabels using an NDC that includes the
registrant’s own labeler code, regardless
of whether the drug is commercially
distributed under the registrant’s own
label or trade name or under the label
or trade name of a private label
distributor.
Under § 207.45, for each drug being
manufactured, repacked, relabeled, or
salvaged for commercial distribution at
an establishment at the time of initial
registration, drug listing information
must be submitted no later than 3
calendar days after the initial
registration of the establishment.
Each registrant must provide the
listing information described under
§ 207.49 for each drug it manufactures
for commercial distribution. Each
registrant must also provide the listing
information for each drug it repacks or
relabels under § 207.53. A registrant
who also relabels or repacks a drug that
it salvages must list the drug it relabels
or repacks in accordance with § 207.53.
Registrants who perform only salvaging
with respect to a drug must provide the
listing information for that drug as
required under § 207.54. Additional
information may be requested for a
listed drug as described in § 207.55.
Under § 207.57, registrants must
update drug listing information
submitted previously (either when the
change is made or, at a minimum, each
June and December). Registrants must
also notify FDA if any listed drug has
been discontinued from marketing or if
any discontinued drug has been
reintroduced and provide listing
information for any drug not yet listed
(at the time of annual establishment
registration if not sooner).
We estimate the burden of the
information collection as follows:
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33937
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Initial establishment registration; §§ 207.17, 207.21,
207.25.
Annual review and update of registration information
(including expedited updates); § 207.29.
Initial listing (including NDC); §§ 207.33, 207.41,
207.45, 207.49, 207.53, 207.54, 207.55.
June and December review and update (or certification) of listing; §§ 207.35, 207.57.
Waiver requests; § 207.65 .............................................
Public disclosure exemption requests; § 207.81(c) .......
Total .......................................................................
1 There
Number of
responses per
respondent
Number of
respondents
Activity; 21 CFR section
Total
annual
responses
Hours per
response
Total hours
1,480
2
2,960
1 ...........................
2,960
10,000
1
10,000
.5 (30 minutes) .....
5,000
1,713
7.28
12,470
1.5 ........................
18,705
5,300
20
106,000
.75 (45 minutes) ...
79,500
1
100
1
1
1
100
.5 (30 minutes) .....
1 ...........................
1
100
........................
........................
........................
..............................
106,266
are no capital or operating and maintenance costs associated with the information collection.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Standard operating procedure (SOP) for
creating and uploading the SPL file
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual records
Average
burden per
recordkeeping
Total hours
Preparation of SOP ...............................
1,000
1
1,000
40
40,000
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1
There are no capital or operating and maintenance costs associated with the information collection.
Based on FDA data, we estimate that
1,480 respondents will submit 2,960
new establishment registrations
annually. Based on the number of
registered establishments in our
database, we estimate 10,000 registrants
will provide 10,000 annual reviews and
updates of registration information
(including expedited updates) or
reviews and certifications that no
changes have occurred. The estimates
include the registration of
establishments for both domestic and
foreign manufacturers, repackers,
relabelers, and drug product salvagers,
and registration information submitted
by anyone acting as an authorized agent
for an establishment that manufactures,
repacks, relabels, or salvages drugs. The
estimates include an additional 80
positron emission tomography (PET)
drug producers who are not exempt
from registration and approximately 30
manufacturers of plasma derivatives.
We estimate that it will take 1 hour
for registrants to submit initial
registration information electronically
for each new establishment. We also
estimate that it will take approximately
30 minutes for each annual review and
update of registration information
(including any expedited updates) or
each review and certification that no
changes have occurred. The burden
hour estimates above are based on our
familiarity with the amount of time it
takes registrants to input registration
information electronically since June
2009. The estimates are an average of
the time it would take to register a
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domestic or foreign establishment and
an average of the time it would take to
review registration information and
update several registration items in the
database or review registration
information and only certify that no
changes have occurred.
Based on the number of drugs listed
annually since June 2009, we estimate
that approximately 1,713 registrants will
report 12,469 new listings annually
(including the information submitted to
obtain a labeler code and to reserve an
NDC for future use).
Based on the number of drugs in our
listing database and the current number
of changes to listing information
submitted, we estimate 5,300 registrants
will each report 20 reviews and updates
(including the information submitted to
revise an NDC) for a total of 106,000
annually.
The estimates for the number of drug
listings include both domestic and
foreign listings, listings submitted by
registrants for products sold under their
own names as well as products intended
for private label distribution, and
information submitted related to an
NDC and to obtain a labeler code. The
estimate for the number of drugs subject
to the listing requirements includes PET
drugs and approximately 30 plasma
derivatives. The estimates for the
number of June and December reviews
and updates of listing information
include the number of changes to drug
characteristics pertaining to the drug
product code to obtain a new NDC and
the reports of the withdrawal of an
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approved drug from sale under 21 CFR
314.81(b)(3)(iii).
Based on our familiarity with the time
required to input listing information
electronically since June 2009, we
estimate that it will take registrants 1
hour and 30 minutes to submit
information electronically for each drug
they list for the first time (for both
foreign and domestic registrant listings).
These estimates are an average of the
time it will take manufacturers,
repackers, relabelers, and drug product
salvagers, with drug product salvagers
taking considerably less time than
manufacturers. The estimates include
the time for submitting the content of
labeling and other labeling in electronic
format. (For drugs subject to an
approved marketing application, the
electronic submission of the content of
labeling under § 314.50(l)(1)(i) is
approved under OMB control number
0910–0001). We also estimate that it
will take 45 minutes for each June and
December review and update. These
estimates represent the average amount
of time to review and update listing
information or to review and certify that
no changes have occurred. The
estimates include the time for
submitting any labeling for each drug,
changes to the drug’s characteristics
submitted for a new NDC, and reports
of the withdrawal of an approved drug
from sale under § 314.81(b)(3)(iii).
In 2009, to help respondents
transition to the current electronic
reporting requirements, FDA issued the
guidance for industry entitled
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‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing.’’ 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. The
burden attributed to the guidance
includes the 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 reflected
in table 2, FDA estimates that
approximately 1,000 firms will expend
40 hours to prepare, review, and
approve an SOP, for a total of 40,000
hours annually.
Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15298 Filed 7–17–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2281]
Innovative Approaches for
Nonprescription Drug Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Innovative Approaches for
Nonprescription Drug Products.’’ This
draft guidance describes two innovative
approaches that may be useful to
consider for demonstrating safety and
effectiveness for a nonprescription drug
product in cases where the drug facts
labeling (DFL) alone is not sufficient to
ensure that the drug product can be
used safely and effectively in a
nonprescription setting: The
development of labeling in addition to
the DFL and the implementation of
additional conditions so that consumers
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SUMMARY:
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appropriately self-select and use the
product.
Submit either electronic or
written comments on the draft guidance
by September 17, 2018 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–2281 for ‘‘Innovative
Approaches for Nonprescription Drug
Products; Draft Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. 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.
FOR FURTHER INFORMATION CONTACT:
Chris Wheeler, Center for Drug
Evaluation and Research, 10903 New
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33934-33938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15298]
-----------------------------------------------------------------------
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each 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 information collection for drug
establishment registration and product listing.
DATES: Submit either electronic or written comments on the collection
of information by September 17, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 17,
[[Page 33935]]
2018. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of September 17,
2018. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0742 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Producers of
Drugs and Listing of Drugs in Commercial Distribution.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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
This information collection supports FDA's drug establishment
registration and listing regulations and associated guidance intended
to assist respondents in this regard. 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), and section 351 of the Public Health Service Act (42
U.S.C. 262). Section 224 of the Food and Drug Administration Amendments
Act of 2007 (Pub. L. 110-85) amended section 510(p) of the FD&C Act to
require electronic drug establishment registration and drug listing.
Regulations implementing these provisions are established under 21 CFR
part 207. Except as provided in Sec. 207.65, all information submitted
must be transmitted to FDA in electronic format by using our electronic
drug registration and listing system, in a form that we can process,
review, and archive. Establishment registration information helps FDA
identify who is manufacturing, repacking, relabeling,
[[Page 33936]]
and salvaging drugs and where those operations are performed. Drug
listing information gives FDA a current inventory of drugs
manufactured, repacked, relabeled, or salvaged for commercial
distribution. Both types of information facilitate implementation and
enforcement of the FD&C Act and are used for many important public
health purposes.
Registration Under Part 207
Unless otherwise exempt under section 510(g) of the FD&C Act or
Sec. 207.13, all manufacturers, repackers, relabelers, and salvagers
must register each domestic establishment that manufactures, repacks,
relabels, or salvages a drug, or an animal feed bearing or containing a
new animal drug, and each foreign establishment that manufactures,
repacks, relabels, or salvages a drug, or an animal feed bearing or
containing a new animal drug, that is imported or offered for import
into the United States. When operations are conducted at more than one
establishment and common ownership and control among all the
establishments exists, the parent, subsidiary, or affiliate company may
submit registration information for all establishments.
Private label distributors who do not also manufacture, repack,
relabel, or salvage drugs are not required to register under part 207.
FDA will accept registration or listing information submitted by a
private label distributor only if it is acting as an authorized agent
for and submitting information that pertains to an establishment that
manufactures, repacks, relabels, or salvages drugs.
Under Sec. 207.21, domestic manufacturers, domestic repackers,
domestic relabelers, and domestic drug product salvagers must complete
initial registration of each establishment no later than 5 calendar
days after beginning to manufacture, repack, relabel, or salvage a
drug. In addition, foreign manufacturers, foreign repackers, foreign
relabelers, and foreign drug product salvagers must register each
establishment before the drug is imported or offered for import into
the United States.
The information that must be provided to FDA for registration is
described in Sec. 207.25 and includes the following: (1) Name of the
owner or operator of each establishment; if a partnership, the name of
each partner; if a corporation, the name of each corporate officer and
director, and the place of incorporation; (2) each establishment's
name, physical address, and telephone number(s); (3) all name(s) of the
establishment, including names under which the establishment conducts
business or names by which the establishment is known; (4) registration
number of each establishment, if previously assigned by FDA; (5) a
Unique Facility Identifier in accordance with the system specified
under section 510 of the FD&C Act; (6) all types of operations
performed at each establishment; (7) name, mailing address, telephone
number, and email address of the official contact for the
establishment, as provided in Sec. 207.69(a); and (8) additionally,
with respect to foreign establishments subject to registration, the
name, mailing address, telephone number, and email address must be
provided for: (a) The U.S. agent, as provided in Sec. 207.69(b); (b)
each importer in the United States of drugs manufactured, repacked,
relabeled, or salvaged at the establishment that is known to the
establishment; and (c) each person who imports or offers for import
such drug to the United States.
Registrants must update their registration information as
prescribed under Sec. 207.29.
National Drug Code (NDC)
The NDC for a drug is a numeric code. Each finished drug product or
unfinished drug subject to the listing requirements of part 207 must
have a unique NDC to identify its labeler, product, and package size
and type. The format of an NDC is described under Sec. 207.33.
Under Sec. 207.35, registrants must notify us of a change in any
of the drug characteristics (except certain identifying information)
for an NDC in Sec. 207.33, and assign a new product code and package
code for that drug.
Listing Under Part 207
Under Sec. 207.41, registrants must list each drug that it
manufactures, repacks, relabels, or salvages for commercial
distribution. Each domestic registrant must list each such drug
regardless of whether the drug enters interstate commerce. When
operations are conducted at more than one establishment, and common
ownership and control exists among all the establishments, the parent,
subsidiary, or affiliate company may submit listing information for any
drug manufactured, repacked, relabeled, or salvaged at any such
establishment. A drug manufactured, repacked, or relabeled for private
label distribution must be listed in accordance with the requirements.
Registrants must provide listing information for each drug in
accordance with the listing requirements described in Sec. Sec.
207.49, 207.53, and 207.54 that correspond to the activity or
activities they engage in for that drug. For both animal and human
drugs, each registrant must list each drug it manufactures, repacks, or
relabels for commercial distribution under the trade name or label of a
private label distributor using an NDC that includes such private label
distributor's labeler code.
Additionally, in the case of human drugs, each registrant must list
each human drug it manufactures, repacks, or relabels using an NDC that
includes the registrant's own labeler code, regardless of whether the
drug is commercially distributed under the registrant's own label or
trade name or under the label or trade name of a private label
distributor.
Under Sec. 207.45, for each drug being manufactured, repacked,
relabeled, or salvaged for commercial distribution at an establishment
at the time of initial registration, drug listing information must be
submitted no later than 3 calendar days after the initial registration
of the establishment.
Each registrant must provide the listing information described
under Sec. 207.49 for each drug it manufactures for commercial
distribution. Each registrant must also provide the listing information
for each drug it repacks or relabels under Sec. 207.53. A registrant
who also relabels or repacks a drug that it salvages must list the drug
it relabels or repacks in accordance with Sec. 207.53. Registrants who
perform only salvaging with respect to a drug must provide the listing
information for that drug as required under Sec. 207.54. Additional
information may be requested for a listed drug as described in Sec.
207.55.
Under Sec. 207.57, registrants must update drug listing
information submitted previously (either when the change is made or, at
a minimum, each June and December). Registrants must also notify FDA if
any listed drug has been discontinued from marketing or if any
discontinued drug has been reintroduced and provide listing information
for any drug not yet listed (at the time of annual establishment
registration if not sooner).
We estimate the burden of the information collection as follows:
[[Page 33937]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of responses per Total annual Hours per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial establishment registration; Sec. Sec. 1,480 2 2,960 1....................................... 2,960
207.17, 207.21, 207.25.
Annual review and update of registration 10,000 1 10,000 .5 (30 minutes)......................... 5,000
information (including expedited updates);
Sec. 207.29.
Initial listing (including NDC); Sec. Sec. 1,713 7.28 12,470 1.5..................................... 18,705
207.33, 207.41, 207.45, 207.49, 207.53,
207.54, 207.55.
June and December review and update (or 5,300 20 106,000 .75 (45 minutes)........................ 79,500
certification) of listing; Sec. Sec.
207.35, 207.57.
Waiver requests; Sec. 207.65................ 1 1 1 .5 (30 minutes)......................... 1
Public disclosure exemption requests; Sec. 100 1 100 1....................................... 100
207.81(c).
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 106,266
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard operating procedure (SOP) for creating and Number of Number of records Total annual Average burden per
uploading the SPL file recordkeepers per recordkeeper records recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of SOP.................................. 1,000 1 1,000 40 40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
Based on FDA data, we estimate that 1,480 respondents will submit
2,960 new establishment registrations annually. Based on the number of
registered establishments in our database, we estimate 10,000
registrants will provide 10,000 annual reviews and updates of
registration information (including expedited updates) or reviews and
certifications that no changes have occurred. The estimates include the
registration of establishments for both domestic and foreign
manufacturers, repackers, relabelers, and drug product salvagers, and
registration information submitted by anyone acting as an authorized
agent for an establishment that manufactures, repacks, relabels, or
salvages drugs. The estimates include an additional 80 positron
emission tomography (PET) drug producers who are not exempt from
registration and approximately 30 manufacturers of plasma derivatives.
We estimate that it will take 1 hour for registrants to submit
initial registration information electronically for each new
establishment. We also estimate that it will take approximately 30
minutes for each annual review and update of registration information
(including any expedited updates) or each review and certification that
no changes have occurred. The burden hour estimates above are based on
our familiarity with the amount of time it takes registrants to input
registration information electronically since June 2009. The estimates
are an average of the time it would take to register a domestic or
foreign establishment and an average of the time it would take to
review registration information and update several registration items
in the database or review registration information and only certify
that no changes have occurred.
Based on the number of drugs listed annually since June 2009, we
estimate that approximately 1,713 registrants will report 12,469 new
listings annually (including the information submitted to obtain a
labeler code and to reserve an NDC for future use).
Based on the number of drugs in our listing database and the
current number of changes to listing information submitted, we estimate
5,300 registrants will each report 20 reviews and updates (including
the information submitted to revise an NDC) for a total of 106,000
annually.
The estimates for the number of drug listings include both domestic
and foreign listings, listings submitted by registrants for products
sold under their own names as well as products intended for private
label distribution, and information submitted related to an NDC and to
obtain a labeler code. The estimate for the number of drugs subject to
the listing requirements includes PET drugs and approximately 30 plasma
derivatives. The estimates for the number of June and December reviews
and updates of listing information include the number of changes to
drug characteristics pertaining to the drug product code to obtain a
new NDC and the reports of the withdrawal of an approved drug from sale
under 21 CFR 314.81(b)(3)(iii).
Based on our familiarity with the time required to input listing
information electronically since June 2009, we estimate that it will
take registrants 1 hour and 30 minutes to submit information
electronically for each drug they list for the first time (for both
foreign and domestic registrant listings). These estimates are an
average of the time it will take manufacturers, repackers, relabelers,
and drug product salvagers, with drug product salvagers taking
considerably less time than manufacturers. The estimates include the
time for submitting the content of labeling and other labeling in
electronic format. (For drugs subject to an approved marketing
application, the electronic submission of the content of labeling under
Sec. 314.50(l)(1)(i) is approved under OMB control number 0910-0001).
We also estimate that it will take 45 minutes for each June and
December review and update. These estimates represent the average
amount of time to review and update listing information or to review
and certify that no changes have occurred. The estimates include the
time for submitting any labeling for each drug, changes to the drug's
characteristics submitted for a new NDC, and reports of the withdrawal
of an approved drug from sale under Sec. 314.81(b)(3)(iii).
In 2009, to help respondents transition to the current electronic
reporting requirements, FDA issued the guidance for industry entitled
[[Page 33938]]
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing.'' 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. The burden attributed to the guidance includes the
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
reflected in table 2, FDA estimates that approximately 1,000 firms will
expend 40 hours to prepare, review, and approve an SOP, for a total of
40,000 hours annually.
Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15298 Filed 7-17-18; 8:45 am]
BILLING CODE 4164-01-P
