New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Comment Request, 23599-23600 [2024-07095]
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Federal Register / Vol. 89, No. 66 / Thursday, April 4, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
Section 3506(c)(2)(A) of the PRA
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Application for
Enrollment in Medicare Part A Internet
Claim (iClaim) Application Screen
Modernized Claims System and
Consolidated Claim Experience Screens;
Use: The Centers for Medicare and
Medicaid Services (CMS) Form
‘‘Application for Hospital Insurance’’
supports sections 1818 and 1818A of the
Social Security Act (the Act) and
corresponding regulations at 42 CFR
406.6 and 406.7.
The CMS–18–F5 is used to establish
entitlement to Part A and enrollment in
Part B for claimants who must file an
application. The application follows the
questions and requirements used by
SSA on the electronic application. This
is done not only for consistency
purposes but because certain
requirements under titles II and XVIII of
the act must be met in order to qualify
for Part A and Part B; including insured
status, relationship and residency. The
form is owned by CMS but is not
utilized by CMS staff. SSA uses the form
to collect information and make Part A
and Part B entitlement determinations
on behalf of CMS. Form Number: CMS–
18F5 (OMB control number: 0938–
0251); Frequency: Once; Affected
Public: Individuals and Households;
Number of Respondents: 1,042,263;
Total Annual Responses: 1,042,263;
Total Annual Hours: 260,566. (For
policy questions regarding this
collection contact Carla Patterson at
410–786–8911 or Carla.Patterson@
cms.hhs.gov).
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: CAHPS Hospice
Survey; Use: CMS launched the
development of the CAHPS Hospice
Survey in 2012. Public reporting of the
results on Hospice Compare started in
2018. The goal of the survey is to
measure the experiences of patients and
their caregivers with hospice care. The
survey was developed to:
• Provide a source of information
from which selected measures could be
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17:01 Apr 03, 2024
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publicly reported to beneficiaries and
their family members as a decision aid
for selection of a hospice program;
• Aid hospices with their internal
quality improvement efforts and
external benchmarking with other
facilities; and
• Provide CMS with information for
monitoring the care provided.
Surveys focusing on patients’
experience of care with their health care
providers are an important part of the
NQS. In addition to publicly reporting
clinical quality measures, CMS is
currently reporting measures from
patient experience of care surveys in a
variety of settings, including in-center
hemodialysis (ICH) centers, hospitals,
home health agencies, and hospices on
the Medicare Care Compare website.
(https://www.medicare.gov/carecompare). Form Number: CMS–10537
(OMB control number: 0938–1257);
Frequency: Once; Affected Public:
Individuals and Households; Number of
Respondents: 1,159,420; Total Annual
Responses: 1,159,420; Total Annual
Hours: 168,115.90. (For policy questions
regarding this collection contact Lauren
Fuentes at 410–786–2290 or 443–618–
2123).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–07162 Filed 4–3–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–0706]
New Dietary Ingredient Notification
Master Files for Dietary Supplements;
Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Comment
Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled ‘‘New
Dietary Ingredient Notification Master
Files for Dietary Supplements.’’ The
draft guidance, when finalized, will
provide recommendations to the dietary
supplement industry on Master Files for
new dietary ingredients. The purpose of
this draft guidance, when finalized, will
be to help industry comply more easily
with the new dietary ingredient
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
23599
notification requirement by providing
recommendations on the submission
and use of Master Files that contain
identity, manufacturing, or safety data
that can be used to support a new
dietary ingredient notification. New
dietary ingredient Master Files are
submitted solely at the discretion of the
Master File owner and are not required
by statute or regulation.
DATES: Submit either electronic or
written comments on the draft guidance
by June 3, 2024 to ensure that we
consider your comment on the draft
guidance before we begin work on the
final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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–
E:\FR\FM\04APN1.SGM
04APN1
ddrumheller on DSK120RN23PROD with NOTICES1
23600
Federal Register / Vol. 89, No. 66 / Thursday, April 4, 2024 / Notices
2024–D–0706 for ‘‘New Dietary
Ingredient Notification Master Files for
Dietary Supplements.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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.’’ We
will review this copy, including the
claimed confidential information, in our
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 Office
of Dietary Supplement Programs, Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
request. See the SUPPLEMENTARY
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17:01 Apr 03, 2024
Jkt 262001
INFORMATION section for electronic
access to the draft guidance.
Lisa
Bieniek, Office of Dietary Supplement
Programs (HFS–810), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2371;
or Lauren Kleinman, Office of
Regulations and Policy (HFS–024),
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is announcing the availability of
a draft guidance for industry titled,
‘‘New Dietary Ingredient Notification
Master Files for Dietary Supplements.’’
We are issuing the draft guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternate approach if it satisfies the
requirements of the applicable statutes
and regulations.
The draft guidance, when finalized,
will provide recommendations to
industry on Master Files for new dietary
ingredient notifications (NDINs). For
purposes of the guidance, a new dietary
ingredient notification Master File
(NDIN Master File or Master File) is a
file containing identity, manufacturing,
and/or safety information relating to a
new dietary ingredient (NDI) that the
Master File owner submits to FDA for
use in evaluating a potential future
NDIN by the Master File owner or by
another person designated by the Master
File owner (e.g., business partner,
supplement manufacturer). An NDIN
Master File contains information about
an NDI, a dietary supplement containing
an NDI, or both. The Master File owner
may refer to the Master File in an NDIN
or may grant written authorization to
other parties to incorporate information
from the Master File by reference in
NDINs. A written authorization granting
a right of reference to a Master File in
an NDIN does not include the right to
see or copy the Master File.
The recommendations in this draft
guidance expand upon and replace the
recommendations related to Master
Files in FDA’s revised draft guidance,
‘‘Dietary Supplements: New Dietary
Ingredient Notifications and Related
Issues,’’ dated August 2016. The
purpose of this draft guidance, when
finalized, will be to help industry
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
comply more easily with the NDIN
requirement in the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by
providing recommendations for the
submission and use of NDIN Master
Files (see section 413(a)(2) of the FD&C
Act (21 U.S.C. 350b(a)(2))). The draft
guidance contains information on
establishing an NDIN Master File,
updating or closing an NDIN Master
File, the use of data from an NDIN
Master File by the Master File owner
and other parties authorized by the
Master File owner, and FDA’s role in
reviewing and administering NDIN
Master Files. Master Files benefit NDIN
submitters with a right of reference by
allowing them to refer to data already on
file with FDA, instead of having to
develop the data themselves and
resubmit it in each NDIN for the same
ingredient.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collection of
information in 21 CFR 190.6 has been
approved under OMB control number
0910–0330, and the collections of
information in 21 CFR part 111 have
been approved under OMB control
number 0910–0606.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: March 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–07095 Filed 4–3–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 89, Number 66 (Thursday, April 4, 2024)]
[Notices]
[Pages 23599-23600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-0706]
New Dietary Ingredient Notification Master Files for Dietary
Supplements; Draft Guidance for Industry; Availability; Agency
Information Collection Activities; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``New Dietary
Ingredient Notification Master Files for Dietary Supplements.'' The
draft guidance, when finalized, will provide recommendations to the
dietary supplement industry on Master Files for new dietary
ingredients. The purpose of this draft guidance, when finalized, will
be to help industry comply more easily with the new dietary ingredient
notification requirement by providing recommendations on the submission
and use of Master Files that contain identity, manufacturing, or safety
data that can be used to support a new dietary ingredient notification.
New dietary ingredient Master Files are submitted solely at the
discretion of the Master File owner and are not required by statute or
regulation.
DATES: Submit either electronic or written comments on the draft
guidance by June 3, 2024 to ensure that we consider your comment on the
draft guidance before we begin work on the final version of the
guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-
[[Page 23600]]
2024-D-0706 for ``New Dietary Ingredient Notification Master Files for
Dietary Supplements.'' 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 Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
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.'' We will review
this copy, including the claimed confidential information, in our
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.govinfo.gov/content/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, 240-402-7500.
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 Office of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Lisa Bieniek, Office of Dietary
Supplement Programs (HFS-810), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2371; or Lauren Kleinman, Office of Regulations and
Policy (HFS-024), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
titled, ``New Dietary Ingredient Notification Master Files for Dietary
Supplements.'' We are issuing the draft guidance consistent with our
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
The draft guidance, when finalized, will provide recommendations to
industry on Master Files for new dietary ingredient notifications
(NDINs). For purposes of the guidance, a new dietary ingredient
notification Master File (NDIN Master File or Master File) is a file
containing identity, manufacturing, and/or safety information relating
to a new dietary ingredient (NDI) that the Master File owner submits to
FDA for use in evaluating a potential future NDIN by the Master File
owner or by another person designated by the Master File owner (e.g.,
business partner, supplement manufacturer). An NDIN Master File
contains information about an NDI, a dietary supplement containing an
NDI, or both. The Master File owner may refer to the Master File in an
NDIN or may grant written authorization to other parties to incorporate
information from the Master File by reference in NDINs. A written
authorization granting a right of reference to a Master File in an NDIN
does not include the right to see or copy the Master File.
The recommendations in this draft guidance expand upon and replace
the recommendations related to Master Files in FDA's revised draft
guidance, ``Dietary Supplements: New Dietary Ingredient Notifications
and Related Issues,'' dated August 2016. The purpose of this draft
guidance, when finalized, will be to help industry comply more easily
with the NDIN requirement in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by providing recommendations for the submission and use of
NDIN Master Files (see section 413(a)(2) of the FD&C Act (21 U.S.C.
350b(a)(2))). The draft guidance contains information on establishing
an NDIN Master File, updating or closing an NDIN Master File, the use
of data from an NDIN Master File by the Master File owner and other
parties authorized by the Master File owner, and FDA's role in
reviewing and administering NDIN Master Files. Master Files benefit
NDIN submitters with a right of reference by allowing them to refer to
data already on file with FDA, instead of having to develop the data
themselves and resubmit it in each NDIN for the same ingredient.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collection of information
in 21 CFR 190.6 has been approved under OMB control number 0910-0330,
and the collections of information in 21 CFR part 111 have been
approved under OMB control number 0910-0606.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov. Use the FDA website
listed in the previous sentence to find the most current version of the
guidance.
Dated: March 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07095 Filed 4-3-24; 8:45 am]
BILLING CODE 4164-01-P