80 FR 76702 - Viral Hepatitis Action Plan-Community Stakeholder Activities Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 237 (December 10, 2015)

Page Range		76702-76703
FR Document		2015-31131

The Department of Health and Human Services (HHS) is seeking public input from state and local governments, community based organizations, academic institutions, professional organizations, advocacy groups, private industry, and other non-federal stakeholders on activities undertaken in 2014-2015 in support of the goals of the national Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis.

Federal Register, Volume 80 Issue 237 (Thursday, December 10, 2015)

[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76702-76703]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31131]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Viral Hepatitis Action Plan--Community Stakeholder Activities 
Request for Information

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: The Department of Health and Human Services (HHS) is seeking 
public input from state and local governments, community based 
organizations, academic institutions, professional organizations, 
advocacy groups, private industry, and other non-federal stakeholders 
on activities undertaken in 2014-2015 in support of the goals of the 
national Action Plan for the Prevention, Care, and Treatment of Viral 
Hepatitis.

DATES: All responses must be received at the address provided below, no 
later than 5:00 p.m. ET on February 8, 2016.

ADDRESSES: Electronic responses are strongly preferred and may be 
addressed to Corinna.Dan@hhs.gov. Written responses should be addressed 
to: U.S. Department of Health and Human Services, 200 Independence Ave. 
SW., Room 443H, Washington, DC 20201. Attention: VHAP--2015RFI

FOR FURTHER INFORMATION CONTACT: Corinna Dan, RN, MPH, Office of HIV/
AIDS and Infectious Disease Policy, (202) 401-9581.

SUPPLEMENTARY INFORMATION: The updated comprehensive national action 
plan, Combating the Silent Epidemic of

[[Page 76703]]

Viral Hepatitis: Action Plan for the Prevention, Care, & Treatment of 
Viral Hepatitis 2014-2016, details more than 150 actions to be 
undertaken between 2014 and 2016 by 20 federal agencies and offices 
from across the U.S. Departments of Health and Human Services (HHS), 
Housing and Urban Development (HUD), Justice (DOJ), and Veterans 
Affairs (VA). While the Viral Hepatitis Action Plan describes efforts 
to be undertaken by federal stakeholders, many of the successes our 
nation has seen in the fight against viral hepatitis have resulted from 
non-federal efforts including those of health departments, academic 
researchers, community-based organizations, professional organizations, 
education and advocacy groups, private industry, and other 
stakeholders. The Viral Hepatitis Action Plan provides a framework 
around which all stakeholders can engage to strengthen the nation's 
response to viral hepatitis and envisions active involvement of and 
innovation by a broad mix of partners from both public and private 
sectors.
    The updated Action Plan describes four main goals to be achieved by 
2020:
     Increase in the proportion of persons who are aware of 
their hepatitis B virus (HBV) infection, from 33% to 66%.
     Increase in the proportion of persons who are aware of 
their hepatitis C virus (HCV) infection, from 45% to 66%.
     Reduce by 25% the number of new cases of HCV infection.
     Eliminate mother-to-child transmission of HBV.
    This request for information seeks public comment on several key 
areas with respect to non-federal efforts undertaken throughout 
calendar years 2014-2015 that are consistent with the four main goals 
of the Viral Hepatitis Action Plan. Comments are sought on (but not 
limited to) the following:
    1. Describe the type of organization or group with which you are 
affiliated (e.g., advocacy, private industry, health care, local, or 
state government, etc.).
    2. What is the most significant need your community/clients 
experience with respect to combating viral hepatitis?
    3. What activities conducted in 2014 and 2015 demonstrated the 
greatest advances toward reaching the goals of the Viral Hepatitis 
Action Plan? Responses are invited (but not limited to) viral hepatitis 
activities in the following areas:
    a. Raising awareness about viral hepatitis among the general 
public, specific targeted populations, and/or community leaders;
    b. Training and/or increasing capacity of health care providers to 
prevent, diagnose, treat viral hepatitis;
    c. Developing strategies to promote timely viral hepatitis 
diagnosis and linkage to care;
    d. Developing/implementing clinical decision support tools and/or 
improved protocols in clinical settings that improve viral hepatitis 
health outcomes;
    e. Implementing strategies to educate women of child-bearing age 
and high risk groups about mother-to-infant transmission of hepatitis 
B;
    f. Reaching people who inject drugs with viral hepatitis 
information and services;
    g. Improving viral hepatitis infection prevention awareness and 
initiatives in medical settings;
    h. Developing strategies to foster stakeholder collaboration and 
sustainable programs; and
    i. Other (please specify).
    4. Please include relevant information such as the dates of 
implementation; names of collaborating organizational partners; related 
Action Plan goal(s); geographic area and populations served, 
quantitative findings and outcomes such as number of tests done, 
proportion of positives identified; and links to online tools, 
resources, and publications.
    Please limit responses to four pages, single-sided, double spaced, 
10 point font.
    Selected activities will be compiled and made available to federal 
partners, stakeholders, and the public in order to foster further 
expansion, innovation, and collaboration toward achieving the goals of 
the Viral Hepatitis Action Plan. Reponses to this RFI will also be used 
to inform future HHS strategic planning and implementation.

    Dated: December 7, 2015.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health, Infectious Diseases, Office of 
the Assistant Secretary for Health.
[FR Doc. 2015-31131 Filed 12-9-15; 8:45 am]
 BILLING CODE 4150-28-P

76702 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices

FOR FURTHER INFORMATION CONTACT: patent term restoration. In a letter dated must be timely (see DATES) and contain
Beverly Friedman, Office of Regulatory March 26, 2014, FDA advised the sufficient facts to merit an FDA
Policy, Food and Drug Administration, USPTO that this animal drug product investigation. (See H. Rept. 857, part 1,
10903 New Hampshire Ave. Bldg. 51, had undergone a regulatory review 98th Cong., 2d sess., pp. 41–42, 1984.)
Rm. 6250, Silver Spring, MD 20993, period and that the approval of Petitions should be in the format
301–796–3600. VERAFLOX represented the first specified in 21 CFR 10.30.
SUPPLEMENTARY INFORMATION: permitted commercial marketing or use Submit petitions electronically to
of the product. Thereafter, the USPTO http://www.regulations.gov at Docket
I. Background requested that FDA determine the No. FDA–2013–S–0610. Submit written
The Drug Price Competition and product’s regulatory review period. petitions (two copies are required) to the
Patent Term Restoration Act of 1984 Division of Dockets Management (HFA–
II. Determination of Regulatory Review
(Pub. L. 98–417) and the Generic 305), Food and Drug Administration,
Animal Drug and Patent Term Period
5630 Fishers Lane, Rm. 1061, Rockville,
Restoration Act (Pub. L. 100–670) FDA has determined that the MD 20852. Petitions that have not been
generally provide that a patent may be applicable regulatory review period for made publicly available on http://
extended for a period of up to 5 years VERAFLOX is 3,285 days. Of this time, www.regulations.gov may be viewed in
so long as the patented item (human 3,235 days occurred during the testing the Division of Dockets Management
drug product, animal drug product, phase of the regulatory review period, between 9 a.m. and 4 p.m., Monday
medical device, food additive, or color while 50 days occurred during the through Friday.
additive) was subject to regulatory approval phase. These periods of time
Dated: December 4, 2015.
review by FDA before the item was were derived from the following dates:
1. The date an exemption under Leslie Kux,
marketed. Under these acts, a product’s
regulatory review period forms the basis section 505(i) of the FD&C Act (21 Associate Commissioner for Policy.
for determining the amount of extension U.S.C. 355(i)) became effective: [FR Doc. 2015–31099 Filed 12–9–15; 8:45 am]
an applicant may receive. November 12, 2003. The applicant BILLING CODE 4164–01–P
A regulatory review period consists of claims July 31, 2002, as the date the
two periods of time: A testing phase and investigational new animal drug
an approval phase. For animal drug application (INAD) became effective. DEPARTMENT OF HEALTH AND
products, the testing phase begins on However, FDA records indicate that the HUMAN SERVICES
the earlier date when either a major INAD effective date was November 12,
environmental effects test was initiated 2003, which was the date on which the Viral Hepatitis Action Plan—
for the drug or when an exemption agency acknowledges the filing of a Community Stakeholder Activities
under section 512(j) of the Federal Food, notice of claimed investigational Request for Information
Drug, and Cosmetic Act (the FD&C Act) exemption for a new animal drug. AGENCY: Office of the Assistant
(21 U.S.C. 360b(j)) became effective and 2. The date the application was Secretary for Health, Office of the
runs until the approval phase begins. initially submitted with respect to the Secretary, Department of Health and
The approval phase starts with the animal drug product under section 512 Human Services.
initial submission of an application to of the FD&C Act (21 U.S.C. 360b): ACTION: Notice.
market the animal drug product and September 19, 2012. FDA has verified
continues until FDA grants permission the applicant’s claim that the new SUMMARY: The Department of Health and
to market the drug product. Although animal drug Application (NADA) for Human Services (HHS) is seeking public
only a portion of a regulatory review VERAFLOX (NADA 141–344) was input from state and local governments,
period may count toward the actual submitted on September 19, 2012. community based organizations,
amount of extension that the Director of 3. The date the application was academic institutions, professional
USPTO may award (for example, half approved: November 7, 2012. FDA has organizations, advocacy groups, private
the testing phase must be subtracted as verified the applicant’s claim that industry, and other non-federal
well as any time that may have occurred NADA 141–344 was approved on stakeholders on activities undertaken in
before the patent was issued), FDA’s November 7, 2012. 2014–2015 in support of the goals of the
determination of the length of a This determination of the regulatory national Action Plan for the Prevention,
regulatory review period for an animal review period establishes the maximum Care, and Treatment of Viral Hepatitis.
drug product will include all of the potential length of a patent extension. DATES: All responses must be received
testing phase and approval phase as However, the USPTO applies several at the address provided below, no later
specified in 35 U.S.C. 156(g)(4)(B). statutory limitations in its calculations than 5:00 p.m. ET on February 8, 2016.
FDA has approved for marketing the of the actual period for patent extension.
ADDRESSES: Electronic responses are
animal drug product VERAFLOX In its application for patent extension,
(pradofloxacin). VERAFLOX is strongly preferred and may be addressed
this applicant seeks 1,901 days of patent
indicated for treatment of skin to Corinna.Dan@hhs.gov. Written
term extension.
infections in cats caused by susceptible responses should be addressed to: U.S.
strains of Pasteurella multocide, III. Petitions Department of Health and Human
Streptococcus canis, Staphylococcus Anyone with knowledge that any of Services, 200 Independence Ave. SW.,
aureus, Staphylococcus felis, and the dates as published are incorrect may Room 443H, Washington, DC 20201.
Attention: VHAP—2015RFI
mstockstill on DSK4VPTVN1PROD with NOTICES

Staphylococcus pseudintermedius. submit either electronic or written
Subsequent to this approval, the USPTO comments and ask for a redetermination FOR FURTHER INFORMATION CONTACT:
received a patent term restoration (see DATES). Furthermore, any interested Corinna Dan, RN, MPH, Office of HIV/
application for VERAFLOX (U.S. Patent person may petition FDA for a AIDS and Infectious Disease Policy,
No. 6,323,213) from Bayer Animal determination regarding whether the (202) 401–9581.
Health GmbH, and the USPTO applicant for extension acted with due SUPPLEMENTARY INFORMATION: The
requested FDA’s assistance in diligence during the regulatory review updated comprehensive national action
determining this patent’s eligibility for period. To meet its burden, the petition plan, Combating the Silent Epidemic of

VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1

Document Created: 2015-12-14 13:28:39
Document Modified: 2015-12-14 13:28:39

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.
Contact		Corinna Dan, RN, MPH, Office of HIV/ AIDS and Infectious Disease Policy, (202) 401-9581.
FR Citation		80 FR 76702