81 FR 8726 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 34 (February 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 34 (February 22, 2016)
| Page Range | 8726-8728 | |
| FR Document | 2016-03543 |
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)] [Notices] [Pages 8726-8728] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03543] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0117] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. DATES: Submit either electronic or written comments on the collection of information by April 22, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-0117 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be [[Page 8727]] 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; OMB Control Number 0910-0670--Extension This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. The intent of the guidance is to provide common labeling for antihypertensive drugs except where differences are clearly supported by clinical data. The guidance encourages applicants to submit labeling supplements containing the new language. The guidance contains two provisions that are subject to OMB review and approval under the PRA and one provision that would be exempt from OMB review: 1. Section IV.C of the guidance requests that the CLINICAL STUDIES section of the Full Prescribing Information of the labeling should include a summary of placebo or active-controlled trials showing evidence of the specific drug's effectiveness in lowering blood pressure. If trials demonstrating cardiovascular outcome benefits exist, those trials also should be summarized in this section. Table 1 in Section V of the guidance contains the specific drugs for which FDA has concluded that such trials exist. If there are no cardiovascular outcome data to cite, one of the following two paragraphs should appear: ``There are no trials of [DRUGNAME] or members of the [name of pharmacologic class] pharmacologic class demonstrating reductions in cardiovascular risk in patients with hypertension,'' or ``There are no trials of [DRUGNAME] demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.'' In the latter case, the applicant's submission generally should refer to table 1 in section V of the guidance. If the applicant believes that table 1 is incomplete, it should submit the clinical evidence for the additional information to Docket No. FDA-2008-D-0150. The labeling submission should reference the submission to the docket. FDA estimates that no more than one submission to the docket will be made annually from one company, and that each submission will take approximately 10 hours to prepare and submit. Concerning the recommendations for the CLINICAL STUDIES section of the Full Prescribing Information of the labeling, FDA regulations at Sec. Sec. 201.56 and 201.57 (21 CFR 201.56 and 201.57) require such labeling, and the information collection associated with these regulations is approved by OMB under OMB control number 0910-0572. 2. Section VI.B of the guidance requests that the format of cardiovascular outcome claim prior approval supplements submitted to FDA under the guidance should include the following information: A statement that the submission is a cardiovascular outcome claim supplement, with reference to the guidance and related Docket No. FDA-2008-D-0150. Applicable FDA forms (e.g., 356h, 3397). Detailed table of contents. Revised labeling to: [cir] Include draft revised labeling conforming to the requirements in Sec. Sec. 201.56 and 201.57 and [cir] include marked-up copy of the latest approved labeling, showing all additions and deletions, with annotations of where supporting data (if applicable) are located in the submission. FDA estimates that approximately 1 cardiovascular outcome claim supplement will be submitted annually from approximately 1 different companies, and that each supplement will take approximately 20 hours to prepare and submit. The guidance also recommends that other labeling changes (e.g., the addition of adverse event data) should be minimized and provided in separate supplements, and that the revision of labeling to conform to Sec. Sec. 201.56 and 201.57 may require [[Page 8728]] substantial revision to the ADVERSE REACTIONS or other labeling sections. 3. Section VI.C of the guidance states that applicants are encouraged to include the following statement in promotional materials for the drug. ``[DRUGNAME] reduces blood pressure, which reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.'' The inclusion of this statement in the promotional materials for the drug would be exempt from OMB review based on 5 CFR 1320.3(c)(2), which states that the public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within the definition of collection of information. FDA requests public comments on the information collection provisions described set forth in the following table: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Hours per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Submission to Docket No. FDA- 1 1 1 10 10 2008-D-0150.................... Cardiovascular Outcome Claim 1 1 1 20 20 Supplement Submission.......... rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total....................... .............. .............. .............. .............. 30 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03543 Filed 2-19-16; 8:45 am] BILLING CODE 4164-01-P
![8726 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
time were derived from the following Dated: February 16, 2016. anyone else’s Social Security number, or
dates: Leslie Kux, confidential business information, such
1. The date an exemption under Associate Commissioner for Policy. as a manufacturing process. Please note
section 505(i) of the Federal Food, Drug, [FR Doc. 2016–03551 Filed 2–19–16; 8:45 am] that if you include your name, contact
and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P
information, or other information that
U.S.C. 355(i)) became effective: identifies you in the body of your
December 10, 2007. The applicant comments, that information will be
DEPARTMENT OF HEALTH AND posted on http://www.regulations.gov.
claims June 26, 2008, as the date the
HUMAN SERVICES • If you want to submit a comment
investigational new drug application with confidential information that you
(IND) became effective. However, FDA do not wish to be made available to the
Food and Drug Administration
records indicate that the IND effective public, submit the comment as a
date was December 10, 2007, which was [Docket No. FDA–2010–N–0117]
written/paper submission and in the
30 days after FDA receipt of the first manner detailed (see ‘‘Written/Paper
IND. Agency Information Collection
Activities; Proposed Collection; Submissions’’ and ‘‘Instructions’’).
2. The date the application was Comment Request; Guidance for Written/Paper Submissions
initially submitted with respect to the Industry on Hypertension Indication:
human drug product under section Submit written/paper submissions as
Drug Labeling for Cardiovascular follows:
505(b) of the FD&C Act: July 12, 2012. Outcome Claims
FDA has verified the applicant’s claim • Mail/Hand delivery/Courier (for
that the new drug application (NDA) for AGENCY: Food and Drug Administration, written/paper submissions): Division of
BREO ELLIPTA (NDA 204275) was HHS. Dockets Management (HFA–305), Food
initially submitted on July 12, 2012. and Drug Administration, 5630 Fishers
ACTION: Notice.
Lane, Rm. 1061, Rockville, MD 20852.
3. The date the application was
SUMMARY: The Food and Drug • For written/paper comments
approved: May 10, 2013. FDA has submitted to the Division of Dockets
Administration (FDA) is announcing an
verified the applicant’s claim that NDA Management, FDA will post your
opportunity for public comment on the
204275 was approved on May 10, 2013. comment, as well as any attachments,
proposed collection of certain
This determination of the regulatory information by the Agency. Under the except for information submitted,
review period establishes the maximum Paperwork Reduction Act of 1995 (the marked and identified, as confidential,
potential length of a patent extension. PRA), Federal Agencies are required to if submitted as detailed in
However, the USPTO applies several publish notice in the Federal Register ‘‘Instructions.’’
statutory limitations in its calculations concerning each proposed collection of Instructions: All submissions received
of the actual period for patent extension. information including each proposed must include the Docket No. FDA–
In its application for patent extension, extension of an existing collection of 2010–N–0117 for ‘‘Agency Information
this applicant seeks 981 days of patent information and to allow 60 days for Collection Activities; Proposed
term extension. public comment in response to the Collection; Comment Request; Guidance
notice. This notice solicits comments on for Industry on Hypertension Indication:
III. Petitions Drug Labeling for Cardiovascular
the information collection associated
with the guidance ‘‘Hypertension Outcome Claims.’’ Received comments
Anyone with knowledge that any of will be placed in the docket and, except
the dates as published are incorrect may Indication: Drug Labeling for
Cardiovascular Outcome Claims,’’ for those submitted as ‘‘Confidential
submit either electronic or written Submissions,’’ publicly viewable at
comments and ask for a redetermination which is intended to assist applicants in
developing labeling for outcome claims http://www.regulations.gov or at the
(see DATES). Furthermore, any interested Division of Dockets Management
person may petition FDA for a for drugs that are indicated to treat
hypertension. between 9 a.m. and 4 p.m., Monday
determination regarding whether the through Friday.
applicant for extension acted with due DATES: Submit either electronic or • Confidential Submissions—To
diligence during the regulatory review written comments on the collection of submit a comment with confidential
period. To meet its burden, the petition information by April 22, 2016. information that you do not wish to be
must be timely (see DATES) and contain ADDRESSES: You may submit comments made publicly available, submit your
sufficient facts to merit an FDA as follows: comments only as a written/paper
investigation. (See H. Rept. 857, part 1, submission. You should submit two
98th Cong., 2d sess., pp. 41–42, 1984.) Electronic Submissions copies total. One copy will include the
Petitions should be in the format Submit electronic comments in the information you claim to be confidential
specified in 21 CFR 10.30. following way: with a heading or cover note that states
Submit petitions electronically to • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
http://www.regulations.gov at Docket www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
No. FDA–2013–S–0610. Submit written instructions for submitting comments. Agency will review this copy, including
petitions (two copies are required) to the Comments submitted electronically, the claimed confidential information, in
Division of Dockets Management (HFA– including attachments, to http:// its consideration of comments. The
mstockstill on DSK4VPTVN1PROD with NOTICES
305), Food and Drug Administration, www.regulations.gov will be posted to second copy, which will have the
5630 Fishers Lane, Rm. 1061, Rockville, the docket unchanged. Because your claimed confidential information
MD 20852. Petitions that have not been comment will be made public, you are redacted/blacked out, will be available
made publicly available on http:// solely responsible for ensuring that your for public viewing and posted on
www.regulations.gov may be viewed in comment does not include any http://www.regulations.gov. Submit
the Division of Dockets Management confidential information that you or a both copies to the Division of Dockets
between 9 a.m. and 4 p.m., Monday third party may not wish to be posted, Management. If you do not wish your
through Friday. such as medical information, your or name and contact information to be
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![Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices 8727
made publicly available, you can the quality, utility, and clarity of the cardiovascular risk in patients with
provide this information on the cover information to be collected; and (4) hypertension,’’ or ‘‘There are no trials of
sheet and not in the body of your ways to minimize the burden of the [DRUGNAME] demonstrating
comments and you must identify this collection of information on reductions in cardiovascular risk in
information as ‘‘confidential.’’ Any respondents, including through the use patients with hypertension, but at least
information marked as ‘‘confidential’’ of automated collection techniques, one pharmacologically similar drug has
will not be disclosed except in when appropriate, and other forms of demonstrated such benefits.’’
accordance with 21 CFR 10.20 and other information technology. In the latter case, the applicant’s
applicable disclosure law. For more submission generally should refer to
Guidance for Industry on Hypertension
information about FDA’s posting of table 1 in section V of the guidance. If
Indication: Drug Labeling for
comments to public dockets, see 80 FR the applicant believes that table 1 is
Cardiovascular Outcome Claims; OMB
56469, September 18, 2015, or access incomplete, it should submit the
Control Number 0910–0670—Extension
the information at: http://www.fda.gov/ clinical evidence for the additional
regulatoryinformation/dockets/ This guidance is intended to assist information to Docket No. FDA–2008–
default.htm. applicants in developing labeling for D–0150. The labeling submission
Docket: For access to the docket to outcome claims for drugs that are should reference the submission to the
read background documents or the indicated to treat hypertension. With docket. FDA estimates that no more
electronic and written/paper comments few exceptions, current labeling for than one submission to the docket will
received, go to http:// antihypertensive drugs includes only be made annually from one company,
www.regulations.gov and insert the the information that these drugs are and that each submission will take
docket number, found in brackets in the indicated to reduce blood pressure; the approximately 10 hours to prepare and
heading of this document, into the labeling does not include information submit. Concerning the
‘‘Search’’ box and follow the prompts on the clinical benefits related to recommendations for the CLINICAL
and/or go to the Division of Dockets cardiovascular outcomes expected from STUDIES section of the Full Prescribing
Management, 5630 Fishers Lane, Rm. such blood pressure reduction. Information of the labeling, FDA
1061, Rockville, MD 20852. However, blood pressure control is well regulations at §§ 201.56 and 201.57 (21
FOR FURTHER INFORMATION CONTACT: FDA
established as beneficial in preventing
CFR 201.56 and 201.57) require such
PRA Staff, Office of Operations, Food serious cardiovascular events, and
labeling, and the information collection
and Drug Administration, 8455 inadequate treatment of hypertension is
associated with these regulations is
Colesville Rd., COLE–14526, Silver acknowledged as a significant public
approved by OMB under OMB control
Spring, MD 20993–0002, PRAStaff@ health problem. FDA believes that the
number 0910–0572.
fda.hhs.gov. appropriate use of these drugs can be
2. Section VI.B of the guidance
encouraged by making the connection
SUPPLEMENTARY INFORMATION: Under the between lower blood pressure and requests that the format of
PRA (44 U.S.C. 3501–3520), Federal improved cardiovascular outcomes cardiovascular outcome claim prior
Agencies must obtain approval from the more explicit in labeling. The intent of approval supplements submitted to FDA
Office of Management and Budget the guidance is to provide common under the guidance should include the
(OMB) for each collection of labeling for antihypertensive drugs following information:
information they conduct or sponsor. except where differences are clearly • A statement that the submission is
‘‘Collection of information’’ is defined supported by clinical data. The a cardiovascular outcome claim
in 44 U.S.C. 3502(3) and 5 CFR guidance encourages applicants to supplement, with reference to the
1320.3(c) and includes Agency requests submit labeling supplements containing guidance and related Docket No. FDA–
or requirements that members of the the new language. 2008–D–0150.
public submit reports, keep records, or The guidance contains two provisions • Applicable FDA forms (e.g., 356h,
provide information to a third party. that are subject to OMB review and 3397).
Section 3506(c)(2)(A) of the PRA (44 approval under the PRA and one • Detailed table of contents.
U.S.C. 3506(c)(2)(A)) requires Federal provision that would be exempt from • Revised labeling to:
Agencies to provide a 60-day notice in OMB review: Æ Include draft revised labeling
the Federal Register concerning each 1. Section IV.C of the guidance conforming to the requirements in
proposed collection of information, requests that the CLINICAL STUDIES §§ 201.56 and 201.57 and
including each proposed extension of an section of the Full Prescribing Æ include marked-up copy of the
existing collection of information, Information of the labeling should latest approved labeling, showing all
before submitting the collection to OMB include a summary of placebo or active- additions and deletions, with
for approval. To comply with this controlled trials showing evidence of annotations of where supporting data (if
requirement, FDA is publishing notice the specific drug’s effectiveness in applicable) are located in the
of the proposed collection of lowering blood pressure. If trials submission.
information set forth in this document. demonstrating cardiovascular outcome FDA estimates that approximately 1
With respect to the following benefits exist, those trials also should be cardiovascular outcome claim
collection of information, FDA invites summarized in this section. Table 1 in supplement will be submitted annually
comments on these topics: (1) Whether Section V of the guidance contains the from approximately 1 different
the proposed collection of information specific drugs for which FDA has companies, and that each supplement
mstockstill on DSK4VPTVN1PROD with NOTICES
is necessary for the proper performance concluded that such trials exist. If there will take approximately 20 hours to
of FDA’s functions, including whether are no cardiovascular outcome data to prepare and submit. The guidance also
the information will have practical cite, one of the following two recommends that other labeling changes
utility; (2) the accuracy of FDA’s paragraphs should appear: (e.g., the addition of adverse event data)
estimate of the burden of the proposed ‘‘There are no trials of [DRUGNAME] should be minimized and provided in
collection of information, including the or members of the [name of separate supplements, and that the
validity of the methodology and pharmacologic class] pharmacologic revision of labeling to conform to
assumptions used; (3) ways to enhance class demonstrating reductions in §§ 201.56 and 201.57 may require
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![8728 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
substantial revision to the ADVERSE comprehensive cardiovascular risk based on 5 CFR 1320.3(c)(2), which
REACTIONS or other labeling sections. management, including, as appropriate, states that the public disclosure of
3. Section VI.C of the guidance states lipid control, diabetes management, information originally supplied by the
that applicants are encouraged to antithrombotic therapy, smoking Federal government to the recipient for
include the following statement in cessation, exercise, and limited sodium the purpose of disclosure to the public
promotional materials for the drug. intake. Many patients will require more is not included within the definition of
‘‘[DRUGNAME] reduces blood than one drug to achieve blood pressure collection of information.
pressure, which reduces the risk of fatal
goals.’’ FDA requests public comments on the
and nonfatal cardiovascular events,
primarily strokes and myocardial The inclusion of this statement in the information collection provisions
infarctions. Control of high blood promotional materials for the drug described set forth in the following
pressure should be part of would be exempt from OMB review table:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
Activity responses per Total hours
respondents responses response
respondent
Submission to Docket No. FDA–2008–D–0150 .................. 1 1 1 10 10
Cardiovascular Outcome Claim Supplement Submission ... 1 1 1 20 20
Total .............................................................................. ........................ ........................ ........................ ........................ 30
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 16, 2016. (RSV) with an Attenuation and ADDRESSES: Requests for a copy of the
Leslie Kux, Temperature Sensitive Phenotype patent application, inquiries, comments
Associate Commissioner for Policy. Conferred by an Amino Acid Deletion’’, and other materials relating to the
[FR Doc. 2016–03543 Filed 2–19–16; 8:45 am] U.S. Provisional Patent Application contemplated license should be directed
BILLING CODE 4164–01–P
Number 61/624,010, filed April 13, to: Peter Soukas, Senior Technology
2012, PCT Patent Application Number Licensing Specialist, Technology
PCT/US2013/030836, filed March 13, Transfer and Intellectual Property
DEPARTMENT OF HEALTH AND 2013, United States Patent Application Office, National Institute of Allergy and
HUMAN SERVICES Number 14/394,226, filed October 13, Infectious Diseases, 5601 Fishers Lane,
2014, European Patent Application Suite 6D, Rockville, MD 20852–9804,
National Institutes of Health Number 13712641.3, filed March 13, Tel: (301) 594–8730 or email: ps193c@
2013, (3) E–216–2014/0, Collins et al., nih.gov.
Prospective Grant of Exclusive ‘‘Versions of Respiratory Syncytial Virus
License: Production of Attenuated SUPPLEMENTARY INFORMATION:
(RSV) Vaccine Candidate LID Delta M2– Respiratory syncytial virus (RSV) is the
Respiratory Syncytial Virus Vaccines 2 with Increased Attenuation’’, U.S. most important cause of viral acute
AGENCY: National Institutes of Health. Provisional Patent Application Number lower respiratory infection (ALRI) in
62/266,199, filed December 11, 2015, (4) infants and children worldwide and is
ACTION: Notice. E–241–2014/0, Collins et al., ‘‘Improved responsible for over 30 million new
RSV F Protein for Expression from a ALRI episodes worldwide and up to
SUMMARY: This is notice, in accordance
Heterologous Vector’’, U.S. Provisional 199,000 deaths in children under five
with 35 U.S.C. 209(c)(1) and 37 CFR
Patent Application Number 62/105,667, (5) years old. In the United States, the
404.7(a)(1)(i), that the National Institute
filed January 20, 2015, PCT Patent virus infects nearly all children at least
of Allergy and Infectious Diseases
Application Number PCT/US2016/ once by the age of two (2) and is the
(NIAID), National Institutes of Health
014154, filed January 20, 2016, and (5) most common cause of bronchiolitis and
(NIH), Department of Health and Human
E–037–2016/0, Collins et al., infant pneumonia, causing up to
Services (HHS), is contemplating the
‘‘Attenuated RSV Vaccine Strains in 125,000 hospitalizations of children
grant of a an exclusive license to
which the NS1 and/or NS2 Genes have each year. RSV disease burden is less
practice the following invention as
been Shifted to Promoter-Distal understood in the developing world, but
embodied in the following patent
Positions’’, U.S. Provisional Patent available data indicates that the virus
applications: (1) E–194–1999/0, Collins
Application Number 62/266,206, filed causes a significant proportion of
et al., ‘‘Production of Attenuated
December 11, 2015, to Sanofi Pasteur, childhood ALRI in these parts of the
Respiratory Syncytial Virus Vaccines
Inc., having a place of business in world, particularly in the first months of
Involving Modification of M2 ORF2’’,
Swiftwater, Pennsylvania, U.S.A. The life. The drug palivizumab (Synagis) can
U.S. Provisional Patent Application
patent rights in this invention have been help prevent RSV disease in high risk
Number 60/143,097, filed July 9, 1999,
assigned to the United States of infants, but it cannot treat or cure
PCT Patent Application Number PCT/
America. already-serious RSV infection. No
mstockstill on DSK4VPTVN1PROD with NOTICES
US2000/18534, filed July 7, 2000, U.S.
Patent Application Number 09/611,829 DATES: Only written comments and/or vaccine exists today to prevent RSV due
(now U.S. Patent Number 6,713,066), application for a license which are to an incomplete understanding of the
and U.S. Patent Application Number 11/ received by the National Institute of body’s immune response to the virus,
011,502 (now U.S. Patent Number Allergy and Infectious Diseases, which has challenged and delayed RSV
7,485,440), (2) E–135–2010/0, Collins et Technology Transfer and Intellectual vaccine development efforts.
al., ‘‘Genetically Stable Live Attenuated Property Office on or before March 8, The methods and compositions of this
Vaccine for Respiratory Syncytial Virus 2016. will be considered. invention provide a means for
VerDate Sep<11>2014 19:03 Feb 19, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1](https://thefederalregister.org/doc/81_FR_8760/page/3.svg)
Document Created: 2016-02-19 23:56:46
Document Modified: 2016-02-19 23:56:46
| 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 April 22, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 8726 |
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