82 FR 32554 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 134 (July 14, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 134 (July 14, 2017)
| Page Range | 32554-32556 | |
| FR Document | 2017-14790 |
[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)] [Notices] [Pages 32554-32556] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14790] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-1140] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study) (OMB Control Number 0920-1140, Expiration Date 10/31/2017)--Revision--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is seeking a one-year OMB approval to extend the ZIPER Study information collection. The Zika Persistence (ZIPER) study will help inform the presence and duration of ZIKV shedding in several body fluids among RT-PCR- positive ZIKV cases from Puerto Rico. It will also provide information regarding the duration of detection of anti-ZIKV IgM antibodies and the time for development of IgG antibodies among the same population. In addition, this study will determine the prevalence of anti-ZIKV IgM and IgG, and virus shedding in body fluids among household contacts of ZIKV cases. We propose to investigate the persistence (shedding) of ZIKV in different body fluids and its relation to [[Page 32555]] immune response to provide a basis for development of non-blood-based diagnostic tools, and target and refine public health interventions to arrest ongoing spread of infection. To do so, we will conduct a prospective cohort study of individuals with reverse transcription- polymerase chain reaction (RT-PCR) positive ZIKV infection and a cross- sectional study of their household contacts. Results and analyses will be used to update relevant counseling messages and recommendations from the CDC. The study will include baseline and follow-up questionnaires and the collection of the following specimens: blood, saliva, urine from participants of all ages, and semen/vaginal secretions from adults (ages 21 years or older) and legally emancipated minors (support themselves financially, live independent of their parents, are pregnant, or have children). Individuals with RT-PCR positive ZIKV infection will be recruited through the Sentinel Enhanced Dengue Surveillance System (SEDSS) at Saint Luke's Episcopal Hospital in Ponce, Puerto Rico and through passive surveillance in selected municipalities in Puerto Rico. SEDSS was established in 2012 through a cooperative agreement between the hospital in Consortium with the Ponce School of Medicine and Ponce Research Institute from the Ponce Health Sciences University and the CDC (Protocol #6214). Specimens will be tested for the presence of ZIKV RNA by RT-PCR at the CDC Dengue Branch Laboratory in San Juan, and positive specimens will be further tested for virus isolation to evaluate infectivity. Each body fluid will be collected on a weekly basis for four weeks and biweekly thereafter until two consecutive negative RT-PCR results are obtained from all specimens. Irrespective of RNA detection, body fluids will also be collected for RT-PCT at 2, 4, and 6 months to investigate intermittent shedding. Analyses of antibody response through titers of IgM and IgG will be performed at baseline and repeated at 2, 4, and 6 months. Among symptomatic participants seven milliliters of blood will be drawn at each study visit split into a tiger top tube (5ml) and a purple top tube (2ml) for a total not to exceed 50 ml during any given 8-week period. At enrollment healthy non-pregnant adults will have 20 ml of blood collected following standard procedures. Two tiger top tubes of 8.5 ml and one 3ml purple top tubes will be collected. These procedures will be repeated at each follow-up visit. RT-PCR-positive participants will be asked to refer up to five household members to establish the percentage of household members with detectable and potentially infectious Zika virus RNA in body fluids. Household members who are found to be ZIKV RT-PCR-positive in any body fluid will be invited to participate in the cohort study. A second study visit will be scheduled with household contact at 2 or 4 months, to detect new infections and estimate incidence. Because the original study consent forms do not include this visit, household contacts will be contacted by study staff and will be consented again using the same consent form. Since gaining OMB approval in October 2016, the project has enrolled 295 Zika virus-infected individuals into the Zika virus Persistence study, which is 55 individuals below the target enrollment of 350 individuals. Preliminary findings have been published in New England Journal of Medicine, where we also expect that the final report that includes the full sample size will be published. This is a request to continue information collection with minor modifications. Modifications have been made to reflect the developing nature of the science surrounding Zika virus infection and potential outcomes associated with infection, as well as additional questions that were best answered by taking advantage of the existing study platform. Specifically, CDC proposes the addition of two components to the collection of data under this study, one of which has already begun: 1. A follow-up household visit has been added to determine how many household members of Zika virus-infected participants become infected during the 4 months following initial screening. For any household members that had no evidence of Zika virus infection at the initial visit, the same questionnaires used at the initial household visit will again be completed ~4 months later. Such information will provide additional information regarding the incidence of Zika virus infections among households with a Zika-positive household member. 2. Additionally, CDC proposes following up with men with Zika virus-positive semen specimens to better understand the effect of Zika virus infection on sperm. To do this, 8-14 semen ejaculates from 10-20 men participating in the ZIPER study will be used to determine the presence and/or detection of the Zika virus in different fractions of the semen ejaculate (i.e., seminal plasma, cellular debris, including White Blood Cells and spermatozoa). CDC has received Institutional Review Board approval for this modification, but information collection has not begun. Authorizing legislation comes from Section 301 of the Public Health Service Act (42 U.S.C. 241). The total estimated annualized number of burden hours is 243. There is no cost to respondents other than the time to participate. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Public health personnel......... Shedding Questionnaire.. 18 30 15/60 General public.................. Shedding Questionnaire 55 8 10/60 (Symptomatics). Shedding Questionnaire 100 1 10/60 (Cross-Sectional Asymptomatics). Questionnaire for men in 30 1 20/60 Semen sub-study. Shedding Eligibility 160 1 2/60 Form. Contact Information Form 32 1 2/60 ---------------------------------------------------------------------------------------------------------------- [[Page 32556]] Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2017-14790 Filed 7-13-17; 8:45 am] BILLING CODE 4163-18-P
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campus. The REOI specified minimum seek input from interested people, comments should address any of the
and additional functional, geographical, organizations, Federally-recognized following: (a) Evaluate whether the
and environmental criteria that would Native American tribes, and Federal, proposed collection of information is
be used to evaluate sites for suitability. state, and regional agencies. necessary for the proper performance of
In particular, candidate sites were to be The purpose of this Notice is to the functions of the agency, including
from 10 to 17 acres in size and located inform interested parties regarding whether the information will have
in Cincinnati, within a certain area CDC’s plan to prepare an EIS for the practical utility; (b) Evaluate the
(Delineated Area) defined by factors proposed Site acquisition in Cincinnati, accuracy of the agencies estimate of the
such as transportation infrastructure, Ohio and the development of the Site burden of the proposed collection of
proximity to other research facilities, into a new consolidated HHS/CDC/ information, including the validity of
and the residence patterns of current NIOSH campus; to provide information the methodology and assumptions used;
NIOSH employees. on the nature of the Proposed Action; (c) Enhance the quality, utility, and
In response to the REOI, GSA received and to initiate the scoping process. The clarity of the information to be
seven expressions of interest (i.e., public scoping meeting will be held on collected; (d) Minimize the burden of
Solicited Sites). Following an August 1, 2017 at the Walnut Hills High the collection of information on those
assessment of each site based on the School, 3250 Victory Parkway, who are to respond, including through
minimum and additional criteria, GSA Cincinnati, Ohio 45207, from 6:00 p.m. the use of appropriate automated,
found that only one site qualified for to 9:00 p.m. Eastern Time. Attendees electronic, mechanical, or other
further consideration. During this should use the Parking Lot D entrance. technological collection techniques or
screening and assessment process, GSA The public scoping meeting will be in other forms of information technology,
identified one additional site (i.e., open house format. General information e.g., permitting electronic submission of
Unsolicited Site) that was added to the on the Site and the Proposed Action responses; and (e) Assess information
qualifying Solicited Site to create a will be provided and representatives of collection costs.
larger parcel better capable of CDC and GSA will be available to To request additional information on
supporting the development of the answer one-on-one questions. There the proposed project or to obtain a copy
proposed campus. The resulting will be no formal presentation or of the information collection plan and
combined site (i.e., the Site) question-and-answer session. instruments, call (404) 639–7570 or
encompasses all land between Martin Participants may arrive at any time send an email to omb@cdc.gov. Written
Luther King Drive East to the south, between 6:00 p.m. and 9:00 p.m. Eastern comments and/or suggestions regarding
Harvey Avenue to the west, Ridgeway Time. Comment forms will be provided the items contained in this notice
Avenue to the north, and Reading Road for written comments and a should be directed to the Attention:
to the east in Cincinnati, Ohio. All other stenographer will be available to CDC Desk Officer, Office of Management
Solicited Sites were eliminated from transcribe oral comments. Through the and Budget, Washington, DC 20503 or
further consideration because they did NEPA scoping process, CDC will also by fax to (202) 395–5806. Written
not adequately meet the selection facilitate consultation with the public as comments should be received within 30
criteria specified in the REOI or, in one required by Section 106 of the NHPA. days of this notice.
case, were withdrawn from
consideration by the offeror. Dated: July 6, 2017. Proposed Project
In accordance with NEPA, as Sandra Cashman, Zika virus persistence in body fluids
implemented by the CEQ regulations (40 Executive Secretary, Centers for Disease of patients with Zika virus infection in
CFR parts 1500–1508), CDC is initiating Control and Prevention. Puerto Rico (ZIPER Study) (OMB
the preparation of an EIS for the [FR Doc. 2017–14474 Filed 7–13–17; 8:45 am] Control Number 0920–1140, Expiration
proposed acquisition of the Site and BILLING CODE 4163–18–P Date 10/31/2017)—Revision—National
construction of a new consolidated Center for Emerging and Zoonotic
CDC/NIOSH campus on the Site. Under Infectious Diseases (NCEZID), Centers
NEPA, Federal agencies are required to DEPARTMENT OF HEALTH AND for Disease Control and Prevention
evaluate the environmental effects of HUMAN SERVICES (CDC).
their proposed actions and a range of
reasonable alternatives to the proposed Centers for Disease Control and Background and Brief Description
action before making a decision. At a Prevention CDC is seeking a one-year OMB
minimum, the EIS will evaluate the [30Day–17–1140]
approval to extend the ZIPER Study
following two alternatives: the Proposed information collection.
Action Alternative (acquisition of the Agency Forms Undergoing Paperwork The Zika Persistence (ZIPER) study
Site and construction of a new Reduction Act Review will help inform the presence and
consolidated CDC/NIOSH campus) and duration of ZIKV shedding in several
the No Action Alternative (continued The Centers for Disease Control and body fluids among RT–PCR-positive
use of the existing campuses for the Prevention (CDC) has submitted the ZIKV cases from Puerto Rico. It will also
foreseeable future). following information collection request provide information regarding the
Scoping Process: In accordance with to the Office of Management and Budget duration of detection of anti-ZIKV IgM
NEPA, a public scoping process will be (OMB) for review and approval in antibodies and the time for development
conducted to establish the range of accordance with the Paperwork of IgG antibodies among the same
issues to be addressed during the Reduction Act of 1995. The notice for population. In addition, this study will
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preparation of the EIS. Scoping is an the proposed information collection is determine the prevalence of anti-ZIKV
early and open process for determining published to obtain comments from the IgM and IgG, and virus shedding in
the scope of issues to be addressed and public and affected agencies. body fluids among household contacts
identifying issues that should be taken Written comments and suggestions of ZIKV cases.
into account in selecting an alternative from the public and affected agencies We propose to investigate the
for implementation. To that end, during concerning the proposed collection of persistence (shedding) of ZIKV in
the scoping process, CDC will actively information are encouraged. Your different body fluids and its relation to
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![32556 Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices
Leroy A. Richardson, solely responsible for ensuring that your contact information to be made publicly
Chief, Information Collection Review Office, comment does not include any available, you can provide this
Office of Scientific Integrity, Office of the confidential information that you or a information on the cover sheet and not
Associate Director for Science, Office of the third party may not wish to be posted, in the body of your comments and you
Director, Centers for Disease Control and such as medical information, your or must identify this information as
Prevention. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
[FR Doc. 2017–14790 Filed 7–13–17; 8:45 am] confidential business information, such as ‘‘confidential’’ will not be disclosed
BILLING CODE 4163–18–P as a manufacturing process. Please note except in accordance with 21 CFR 10.20
that if you include your name, contact and other applicable disclosure law. For
information, or other information that more information about FDA’s posting
DEPARTMENT OF HEALTH AND identifies you in the body of your of comments to public dockets, see 80
HUMAN SERVICES comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Food and Drug Administration • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
[Docket No. FDA–2007–D–0369] with confidential information that you 23389.pdf.
do not wish to be made available to the Docket: For access to the docket to
Product-Specific Guidances; Draft and public, submit the comment as a read background documents or the
Revised Draft Guidances for Industry; written/paper submission and in the electronic and written/paper comments
Availability manner detailed (see ‘‘Written/Paper received, go to https://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
AGENCY: Food and Drug Administration,
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Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
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among other things, the design of Staff, FDA will post your comment, as and Drug Administration, 10001 New
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developed using the process described viewable at https://www.regulations.gov Silver Spring, MD 20993–0002, 301–
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considers your comment on a draft submit a comment with confidential In the Federal Register of June 11,
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before it begins work on the final made publicly available, submit your availability of a guidance for industry
version of the guidance, submit either comments only as a written/paper entitled ‘‘Bioequivalence
electronic or written comments on the submission. You should submit two Recommendations for Specific
draft guidance by September 12, 2017. copies total. One copy will include the Products’’ that explained the process
ADDRESSES: You may submit comments information you claim to be confidential that would be used to make product-
as follows: with a heading or cover note that states specific guidances available to the
‘‘THIS DOCUMENT CONTAINS public on FDA’s Web site at http://
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Submit electronic comments in the Agency will review this copy, including ComplianceRegulatoryInformation/
following way: the claimed confidential information, in Guidances/default.htm.
• Federal eRulemaking Portal: its consideration of comments. The As described in that guidance, FDA
mstockstill on DSK30JT082PROD with NOTICES
https://www.regulations.gov. Follow the second copy, which will have the adopted this process as a means to
instructions for submitting comments. claimed confidential information develop and disseminate product-
Comments submitted electronically, redacted/blacked out, will be available specific guidances and provide a
including attachments, to https:// for public viewing and posted on meaningful opportunity for the public to
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Document Created: 2018-10-24 11:17:04
Document Modified: 2018-10-24 11:17:04
| 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 | |
| FR Citation | 82 FR 32554 |
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