82 FR 23584 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 98 (May 23, 2017)

Page Range		23584-23587
FR Document		2017-10535

The Food and Drug Administration (FDA or Agency) 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 proposed 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 the information collection requirements related to the exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS).

Federal Register, Volume 82 Issue 98 (Tuesday, May 23, 2017)

[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23584-23587]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-10535]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0588]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exceptions or Alternatives to Labeling Requirements
for Products Held by the Strategic National Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) 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 proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice

[[Page 23585]]

solicits comments on the information collection requirements related to
the exceptions or alternatives to labeling requirements for products
held by the Strategic National Stockpile (SNS).

DATES: Submit either electronic or written comments on the collection
of information by July 24, 2017.

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 July 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 24, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2010-N-0588 for ``Exceptions or Alternatives to Labeling
Requirements for Products Held by the Strategic National Stockpile.''
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 Division of Dockets Management 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 Division of Dockets Management. 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.thefederalregister.org/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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.

Exceptions or Alternatives to Labeling Requirements for Products Held
by the Strategic National Stockpile--OMB Control Number 0910-0614--
Extension

Under the Public Health Service Act (PHS Act), the Department of
Health and Human Services stockpiles medical products that are
essential to the health security of the Nation (see the PHS Act, 42
U.S.C. 247d-6b). This collection of medical products for use during
national health emergencies, known as the SNS, is to ``provide for the
emergency health security of the United States, including the emergency
health security of children and other

[[Page 23586]]

vulnerable populations, in the event of a bioterrorist attack or other
public health emergency.''
It may be appropriate for certain medical products that are or will
be held in the SNS to be labeled in a manner that would not comply with
certain FDA labeling regulations given their anticipated circumstances
of use in an emergency. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
Under 21 CFR 201.26, 610.68, 801.128, and 809.11 (Sec. Sec.
201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center
Director may grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included
in the SNS. An exception or alternative granted under the regulations
may include conditions or safeguards so that the labeling for such
products includes appropriate information necessary for the safe and
effective use of the product given the product's anticipated
circumstances of use. Any grant of an exception or alternative will
only apply to the specified lots, batches, or other units of medical
products in the request. The appropriate FDA Center Director may also
grant an exception or alternative to the labeling provisions specified
in the regulations on his or her own initiative.
Under Sec. Sec. 201.26(b)(1)(i) (human drug products),
610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical
devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human
use), an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate FDA Center Director. Except when initiated by an FDA Center
Director, a request for an exception or alternative must be in writing
and must:
Identify the specified lots, batches, or other units of
the affected product;
Identify the specific labeling provisions under the
regulations that are the subject of the request;
Explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
Describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
Provide copies of the proposed labeling of the specified
lots, batches, or other units of the affected product that will be
subject to the exception or alternative; and
Provide any other information requested by the FDA Center
Director in support of the request.
If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the new drug application, biologics
license application, premarket approval application, or premarket
notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
the regulations may be used to satisfy certain reporting obligations
relating to changes to product applications under Sec. Sec. 314.70,
601.12, 814.39 and 807.81 (21 CFR 314.70 (human drugs), 21 CFR 601.12
(biological products), 21 CFR 814.39 (medical devices subject to
premarket approval), or 21 CFR 807.81 (medical devices subject to
510(k) clearance requirements)). The information collection provisions
in Sec. Sec. 314.70, 601.12, 807.81, and 814.39 have been approved
under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 0910-
0231, respectively. On a case-by-case basis, the appropriate FDA Center
Director may also determine when an exception or alternative is granted
that certain safeguards and conditions are appropriate, such as
additional labeling on the SNS products, so that the labeling of such
products would include information needed for safe and effective use
under the anticipated circumstances of use.
Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute, or store affected SNS products. Based on data from fiscal
years 2014 and 2015, FDA estimates an average of one request annually
for an exception or alternative received by FDA. FDA estimates an
average of 24 hours preparing each request. The average burden per
response for each submission is based on the estimated time that it
takes to prepare a supplement to an application, which may be
considered similar to a request for an exception or alternative. To the
extent that labeling changes not already required by FDA regulations
are made in connection with an exception or alternative granted under
the regulations, FDA is estimating one occurrence annually in the event
FDA would require any additional labeling changes not already covered
by FDA regulations. FDA estimates 8 hours to develop and revise the
labeling to make such changes. The average burden per response for each
submission is based on the estimated time to develop and revise the
labeling to make such changes.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i), 1 1 1 24 24
610.68(b)(1)(i),
801.128(b)(1)(i), and
809.11(b)(1)(i)................
201.26(b)(1)(i), 1 1 1 8 8
610.68(b)(1)(i),
801.128(b)(1)(i), and
809.11(b)(1)(i)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 23587]]

Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10535 Filed 5-22-17; 8:45 am]
BILLING CODE 4164-01-P

23584 Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices

in furtherance of FDA’s goal of ensuring consent form requires that the nominee day notice requesting public comment
transparency regarding the affirm that the CV does not include any on the proposed collection of
qualifications of individuals selected to confidential information, including information. One comment was received
serve on FDA advisory committees, and information pertaining to third parties in support of the information collection
in recognition that individual advisory that the nominee is not permitted to and recommended no changes to the
committee members are best situated to disclose. A nominee will be required to Agency’s burden estimate. On our own
evaluate the confidentiality of submit a signed consent form as a part initiative, however, we have revised the
information contained in their CVs, of the nomination package in order for estimate provided in our 60 day notice
including any considerations raised by the nomination to be considered to reflect an increase of 23.5 burden
their relationships and agreements with complete.
hours and 94 responses. While we
All nominations for new advisory
third parties, FDA will now be requiring believe our original burden estimate
committee members will be required to
that all CVs submitted as part of the be submitted through FDA’s Web site at accurately reflects the time burden
nomination process for positions on http://accessdata.test.fda.gov/scripts/ associated with providing the specific
FDA advisory committees be FACTRSPortal/FACTRS/index.cfm, or data elements, but we have increased
accompanied by a written consent form any successor system, and the the number of respondents to the
stating that, if the nominee is accepted submission will be required to be collection to include Industry
as a member of an FDA advisory accompanied by the consent form, on or Representative members of FDA
committee, the nominee consents to the after the date of OMB approval for this advisory committees.
publication of the nominee’s CV to information collection. We therefore estimate the burden of
FDA’s Web site, without FDA removing In the Federal Register of February 6, the information collection as follows:
or redacting any information. The 2017 (82 FR 9383), we published a 60-

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
21 CFR part 14; subpart E—members of advisory Number of Total annual
responses per burden per Total hours
committees respondents responses
respondent response

Advisory Committee Membership Nominations ................... 583 1 583 0.25 145.75
(15 minutes)
Representative Member Submission of Updated Informa-
tion .................................................................................... 64 1 64 0.25 16.0
(15 minutes)

Total .............................................................................. ........................ ........................ 647 ........................ 161.75
1 There are no capital or operating and maintenance costs associated with the information collection.

Based on a review of data, we members, mostly Industry DEPARTMENT OF HEALTH AND
received 638 nominations for representatives. While some positions HUMAN SERVICES
membership to FDA advisory are vacant, we anticipate the positions
committees in Fiscal Year (FY) 2011; we will be filled during the year. The Food and Drug Administration
received 603 nominations in FY 2012; request for the updated CV and consent
we received 622 in FY 2013; we [Docket No. FDA–2010–N–0588]
will be made through email
received 545 in FY 2014; and we communications by the Designated Agency Information Collection
received 505 nominations in FY 2015. Federal Officer of the committee. We Activities; Proposed Collection;
By averaging the number of nominations anticipate that the burden to the Comment Request; Exceptions or
received annually over the past 5 years, respondent will be the same as that for Alternatives to Labeling Requirements
we estimate there are approximately 583 new nominations. We estimate each for Products Held by the Strategic
respondents to the information response will require 15 minutes (0.25) National Stockpile
collection. We estimate it takes
for a total of 16 annual hours.
respondents 15 minutes to complete an AGENCY: Food and Drug Administration,
initial nomination, where Dated: May 18, 2017. HHS.
accompanying documentation is already Anna K. Abram, ACTION: Notice.
available or has been prepared in Deputy Commissioner for Policy, Planning,
advance by respondents. Multiplying 15 Legislation, and Analysis. SUMMARY: The Food and Drug
minutes (0.25) by the number of [FR Doc. 2017–10531 Filed 5–22–17; 8:45 am] Administration (FDA or Agency) is
respondents to the information announcing an opportunity for public
BILLING CODE 4164–01–P
collection (583) equals 145.75 annual comment on the proposed collection of
burden hours. certain information by the Agency.
We have also included a burden Under the Paperwork Reduction Act of
estimate for members who currently 1995 (PRA), Federal Agencies are
sradovich on DSK3GMQ082PROD with NOTICES

serve on FDA advisory committees who required to publish notice in the
are not Special Government and Regular Federal Register concerning each
Government Employees and who must proposed collection of information,
submit an updated CV and an executed/ including each proposed extension of an
completed consent form annually. existing collection of information, and
Currently there are 64 authorized to allow 60 days for public comment in
positions for these Representative response to the notice. This notice

VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1

23586 Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices

vulnerable populations, in the event of manufactures (including labeling, approval), or 21 CFR 807.81 (medical
a bioterrorist attack or other public packing, relabeling, or repackaging), devices subject to 510(k) clearance
health emergency.’’ distributes, or stores such products that requirements)). The information
It may be appropriate for certain are or will be included in the SNS may collection provisions in §§ 314.70,
medical products that are or will be submit, with written concurrence from 601.12, 807.81, and 814.39 have been
held in the SNS to be labeled in a a SNS official, a written request for an approved under OMB control numbers
manner that would not comply with exception or alternative to certain 0910–0001, 0910–0338, 0910–0120, and
certain FDA labeling regulations given labeling requirements to the appropriate 0910–0231, respectively. On a case-by-
their anticipated circumstances of use in FDA Center Director. Except when case basis, the appropriate FDA Center
an emergency. However, noncompliance initiated by an FDA Center Director, a Director may also determine when an
with these labeling requirements could request for an exception or alternative exception or alternative is granted that
render such products misbranded under must be in writing and must: certain safeguards and conditions are
section 502 of the Federal Food, Drug, • Identify the specified lots, batches, appropriate, such as additional labeling
and Cosmetic Act (21 U.S.C. 352). or other units of the affected product; on the SNS products, so that the
Under 21 CFR 201.26, 610.68, • Identify the specific labeling labeling of such products would include
801.128, and 809.11 (§§ 201.26, 610.68, provisions under the regulations that are information needed for safe and
801.128, and 809.11), the appropriate the subject of the request;
effective use under the anticipated
• Explain why compliance with the
FDA Center Director may grant a request circumstances of use.
specified labeling provisions could
for an exception or alternative to certain Respondents to this collection of
adversely affect the safety, effectiveness,
regulatory provisions pertaining to the information are entities that
or availability of the product subject to
labeling of human drugs, biological manufacture (including labeling,
the request;
products, medical devices, and in vitro • Describe any proposed safeguards packing, relabeling, or repackaging),
diagnostics that currently are or will be or conditions that will be implemented distribute, or store affected SNS
included in the SNS if certain criteria so that the labeling of the product products. Based on data from fiscal
are met. The appropriate FDA Center includes appropriate information years 2014 and 2015, FDA estimates an
Director may grant an exception or necessary for the safe and effective use average of one request annually for an
alternative to certain FDA labeling of the product given the anticipated exception or alternative received by
requirements if compliance with these circumstances of use of the product; FDA. FDA estimates an average of 24
labeling requirements could adversely • Provide copies of the proposed hours preparing each request. The
affect the safety, effectiveness, or labeling of the specified lots, batches, or average burden per response for each
availability of products that are or will other units of the affected product that submission is based on the estimated
be included in the SNS. An exception will be subject to the exception or time that it takes to prepare a
or alternative granted under the alternative; and supplement to an application, which
regulations may include conditions or • Provide any other information may be considered similar to a request
safeguards so that the labeling for such requested by the FDA Center Director in
products includes appropriate for an exception or alternative. To the
support of the request. extent that labeling changes not already
information necessary for the safe and If the request is granted, the
effective use of the product given the required by FDA regulations are made
manufacturer may need to report to FDA
product’s anticipated circumstances of any resulting changes to the new drug in connection with an exception or
use. Any grant of an exception or application, biologics license alternative granted under the
alternative will only apply to the application, premarket approval regulations, FDA is estimating one
specified lots, batches, or other units of application, or premarket notification occurrence annually in the event FDA
medical products in the request. The (510(k)) in effect, if any. The submission would require any additional labeling
appropriate FDA Center Director may and grant of an exception or an changes not already covered by FDA
also grant an exception or alternative to alternative to the labeling requirements regulations. FDA estimates 8 hours to
the labeling provisions specified in the specified in the regulations may be used develop and revise the labeling to make
regulations on his or her own initiative. to satisfy certain reporting obligations such changes. The average burden per
Under §§ 201.26(b)(1)(i) (human drug relating to changes to product response for each submission is based
products), 610.68(b)(1)(i) (biological applications under §§ 314.70, 601.12, on the estimated time to develop and
products), 801.128(b)(1)(i) (medical 814.39 and 807.81 (21 CFR 314.70 revise the labeling to make such
devices), and 809.11(b)(1)(i) (in vitro (human drugs), 21 CFR 601.12 changes.
diagnostic products for human use), an (biological products), 21 CFR 814.39 FDA estimates the burden of this
SNS official or any entity that (medical devices subject to premarket collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in hours)

201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and
sradovich on DSK3GMQ082PROD with NOTICES

809.11(b)(1)(i) ................................................................... 1 1 1 24 24
201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and
809.11(b)(1)(i) ................................................................... 1 1 1 8 8

Total .............................................................................. ........................ ........................ ........................ ........................ 32
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1

Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices 23587

Dated: May 18, 2017. applicable, the business or professional Dated: May 17, 2017.
Anna K. Abram, affiliation of the interested person. Michelle Trout,
Deputy Commissioner for Policy, Planning, In the interest of security, NIH has Program Analyst, Office of Federal Advisory
Legislation, and Analysis. instituted stringent procedures for entrance Committee Policy.
onto the NIH campus. All visitor vehicles,
[FR Doc. 2017–10535 Filed 5–22–17; 8:45 am] including taxicabs, hotel, and airport shuttles [FR Doc. 2017–10454 Filed 5–22–17; 8:45 am]
BILLING CODE 4164–01–P will be inspected before being allowed on BILLING CODE 4140–01–P
campus. Visitors will be asked to show one
form of identification (for example, a
DEPARTMENT OF HEALTH AND government-issued photo ID, driver’s license, DEPARTMENT OF HEALTH AND
HUMAN SERVICES or passport) and to state the purpose of their HUMAN SERVICES
visit.
National Institutes of Health (Catalogue of Federal Domestic Assistance National Institutes of Health
Program Nos. 93.846, Arthritis,
National Institute of Arthritis and Musculoskeletal and Skin Diseases Research, National Human Genome Research
Musculoskeletal and Skin Diseases: National Institutes of Health, HHS) Institute; Notice of Closed Meeting
Notice of Meeting Dated: May 17, 2017. Pursuant to section 10(d) of the
Pursuant to section 10(d) of the Sylvia L. Neal, Federal Advisory Committee Act, as
Federal Advisory Committee Act, as Program Analyst, Office of Federal Advisory amended (5 U.S.C. App.), notice is
amended (5 U.S.C. App.), notice is Committee Policy. hereby given of the following meeting.
hereby given of a meeting of the [FR Doc. 2017–10458 Filed 5–22–17; 8:45 am] The meeting will be closed to the
National Arthritis and Musculoskeletal BILLING CODE 4140–01–P public in accordance with the
and Skin Diseases Advisory Council. provisions set forth in sections
The meeting will be open to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
public as indicated below, with DEPARTMENT OF HEALTH AND as amended. The grant applications and
attendance limited to space available. HUMAN SERVICES the discussions could disclose
Individuals who plan to attend and confidential trade secrets or commercial
need special assistance, such as sign National Institutes of Health property such as patentable material,
language interpretation or other and personal information concerning
reasonable accommodations, should National Center for Complementary & individuals associated with the grant
notify the Contact Person listed below Integrative Health; Notice of Closed applications, the disclosure of which
in advance of the meeting. Meeting would constitute a clearly unwarranted
The meeting will be closed to the invasion of personal privacy.
public in accordance with the Pursuant to section 10(d) of the
Federal Advisory Committee Act, as Name of Committee: National Human
provisions set forth in sections Genome Research Institute Special Emphasis
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., amended (5 U.S.C. App.), notice is
hereby given of the following meeting. Panel; U41 Genomic Resources.
as amended. The grant applications and Date: June 12, 2017.
the discussions could disclose The meeting will be closed to the Time: 2:00 p.m. to 5:00 p.m.
confidential trade secrets or commercial public in accordance with the Agenda: To review and evaluate grant
property such as patentable material, provisions set forth in sections applications.
and personal information concerning 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: National Human Genome Research
as amended. The grant applications and Institute, 5635 Fishers Lane, Conference
individuals associated with the grant
the discussions could disclose Room 3146, Rockville, MD 20852 (Telephone
applications, the disclosure of which Conference Call).
would constitute a clearly unwarranted confidential trade secrets or commercial Contact Person: Keith McKenney, Ph.D.,
invasion of personal privacy. property such as patentable material, Scientific Review Officer, National Human
and personal information concerning Genome Research Institute, 5635 Fishers
Name of Committee: National Arthritis and
Musculoskeletal and Skin Diseases Advisory individuals associated with the grant Lane, Suite 4076, Bethesda, MD 20814, 301–
Council. applications, the disclosure of which 594–4280, mckenneyk@mail.nih.gov.
Date: June 21, 2017. would constitute a clearly unwarranted (Catalogue of Federal Domestic Assistance
Open: 8:30 a.m. to 1:00 p.m. invasion of personal privacy. Program Nos. 93.172, Human Genome
Agenda: To discuss program policies and Research, National Institutes of Health, HHS)
Name of Committee: National Center for
issues.
Complementary and Integrative Health Dated: May 17, 2017.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Bethesda, MD Special Emphasis Panel; NIH-DoD–VA Pain Sylvia L. Neal,
20892. Management Collaboratory—Coordinating
Program Analyst, Office of Federal Advisory
Closed: 1:00 p.m. to 4:00 p.m. Center (U24).
Committee Policy.
Agenda: To review and evaluate grant Date: June 23, 2017.
Time: 2:00 p.m. to 5:00 p.m. [FR Doc. 2017–10455 Filed 5–22–17; 8:45 am]
applications.
Place: National Institutes of Health, Agenda: To review and evaluate grant BILLING CODE 4140–01–P

Building 31, 31 Center Drive, Bethesda, MD applications.
20892. Place: Bethesda Marriott, 5151 Pooks Hill
Contact Person: Melinda Nelson, Acting Road, Bethesda, MD 20817. DEPARTMENT OF HEALTH AND
Director, National Institute of Arthritis and Contact Person: Viatcheslav A HUMAN SERVICES
Musculoskeletal and Skin Diseases, Grants Soldatenkov, MD, Ph.D., Scientific Review
sradovich on DSK3GMQ082PROD with NOTICES

Management Branch, 45 Center Drive, Officer, Office of Scientific Review, Division National Institutes of Health
Natcher Building, Room 5A49, Bethesda, MD of Extramural Activities, NCCIH/NIH, 6707
20892, (301) 594–3535, mn23z@nih.gov. Democracy Blvd., Suite 401, Bethesda, MD National Institute of Diabetes and
Any interested person may file written 20892, soldatenkovv@mail.nih.gov. Digestive and Kidney Diseases; Notice
comments with the committee by forwarding (Catalogue of Federal Domestic Assistance of Closed Meetings
the statement to the Contact Person listed on Program Nos. 93.213, Research and Training
this notice. The statement should include the in Complementary and Integrative Health, Pursuant to section 10(d) of the
name, address, telephone number and when National Institutes of Health, HHS) Federal Advisory Committee Act, as

VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1

Document Created: 2017-05-23 02:14:43
Document Modified: 2017-05-23 02:14:43

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by July 24, 2017.
Contact		JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation		82 FR 23584

82 FR 23584 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 98 (May 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration