80 FR 31379 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 105 (June 2, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 105 (June 2, 2015)
| Page Range | 31379-31380 | |
| FR Document | 2015-13314 |
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)] [Notices] [Pages 31379-31380] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13314] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement, RFA-EH- 15-002, Development and validation of laboratory procedures using next generation sequencing technologies to assess genes causing severe combined immune deficiency (SCID) in state newborn screening laboratories. Times and Dates: 11:00 a.m.-3:00 p.m., EDT, June 25, 2015 (CLOSED). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) [[Page 31380]] and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Development and validation of laboratory procedures using next generation sequencing technologies to assess genes causing severe combined immune deficiency (SCID) in state newborn screening laboratories'', EH15-002. Contact Person for More Information: Jane Suen, Dr.P.H., M.S., Scientific Review Officer, CDC, 4770 Buford Highway, NE., Mailstop F63, Atlanta, Georgia 30341-3724, Telephone (770) 488-4281. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2015-13314 Filed 6-1-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices 31379
DEPARTMENT OF HEALTH AND other forms of information technology, cases occur in Arizona or California, so
HUMAN SERVICES e.g., permitting electronic submission of the epidemiology of this disease has
responses; and (e) Assess information been well-described for these states, but
Centers for Disease Control and collection costs. little is known about the features of
Prevention To request additional information on cases in other states.
[30Day–15–15UR]
the proposed project or to obtain a copy Enhanced surveillance in low- and
of the information collection plan and non-endemic states will help determine
Agency Forms Undergoing Paperwork instruments, call (404) 639–7570 or which information is most important to
Reduction Act Review send an email to omb@cdc.gov. Written collect during routine surveillance and
comments and/or suggestions regarding will help assess the suitability of the
The Centers for Disease Control and the items contained in this notice
Prevention (CDC) has submitted the Council of State and Territorial
should be directed to the Attention: Epidemiologists (CSTE) case definition
following information collection request CDC Desk Officer, Office of Management
to the Office of Management and Budget for coccidioidomycosis in these areas.
and Budget, Washington, DC 20503 or Primary prevention strategies for
(OMB) for review and approval in by fax to (202) 395–5806. Written
accordance with the Paperwork coccidioidomycosis have not yet been
comments should be received within 30 proven to be effective, so public health
Reduction Act of 1995. The notice for days of this notice.
the proposed information collection is efforts may be best aimed at promoting
published to obtain comments from the Proposed Project awareness of coccidioidomycosis among
public and affected agencies. healthcare providers and the general
Enhanced Surveillance of
Written comments and suggestions public. Improved surveillance data are
Coccidioidomycosis in Low- and Non-
from the public and affected agencies essential for identifying such
Endemic States—New—National Center
concerning the proposed collection of opportunities to promote awareness
for Emerging and Zoonotic Infectious
information are encouraged. Your about this disease and for determining
Diseases (NCEZID), Centers for Disease
comments should address any of the its true public health burden.
Control and Prevention (CDC).
following: (a) Evaluate whether the State health department personnel in
proposed collection of information is Background and Brief Description participating low- and non-endemic
necessary for the proper performance of Coccidioidomycosis, also called states will conduct telephone interviews
the functions of the agency, including ‘‘Valley fever,’’ is a nationally notifiable with coccidioidomycosis cases reported
whether the information will have fungal infection caused by inhalation of during one calendar year that meet the
practical utility; (b) Evaluate the soil-dwelling Coccidioides spp. In the CSTE case definition and will record
accuracy of the agencies estimate of the United States, coccidioidomycosis is responses on a standardized form. State
burden of the proposed collection of known to be endemic in the health department personnel will use
information, including the validity of southwestern states, but new evidence the form to collect information on
the methodology and assumptions used; suggests that the true endemic areas demographics, underlying medical
(c) Enhance the quality, utility, and may be broader than previously conditions, travel history, symptom type
clarity of the information to be recognized. Approximately 10,000 and duration, healthcare-seeking
collected; (d) Minimize the burden of coccidioidomycosis cases are reported behaviors, diagnosis, treatment, and
the collection of information on those in the U.S. each year to the National outcomes.
who are to respond, including through Notifiable Disease Surveillance System OMB approval is requested for two
the use of appropriate automated, (NNDSS), but this system captures years. Participation is voluntary. The
electronic, mechanical, or other limited clinical and epidemiological total estimated annualized burden is 48
technological collection techniques or information about reported cases. Most hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
State Health Department Personnel ............... Case Report Form for Coccidioidomycosis 145 1 20/60
(Valley Fever) Enhanced Surveillance.
Leroy A. Richardson, DEPARTMENT OF HEALTH AND review of applications in response to
Chief, Information Collection Review Office, HUMAN SERVICES Funding Opportunity Announcement,
Office of Scientific Integrity, Office of the RFA–EH–15–002, Development and
Associate Director for Science, Office of the Centers for Disease Control and validation of laboratory procedures
Director, Centers for Disease Control and Prevention using next generation sequencing
Prevention. technologies to assess genes causing
Disease, Disability, and Injury
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[FR Doc. 2015–13161 Filed 6–1–15; 8:45 am] severe combined immune deficiency
BILLING CODE 4163–18–P
Prevention and Control Special (SCID) in state newborn screening
Emphasis Panel (SEP): Initial Review laboratories.
Times and Dates: 11:00 a.m.–3:00
In accordance with section 10(a)(2) of p.m., EDT, June 25, 2015 (CLOSED).
the Federal Advisory Committee Act Place: Teleconference.
(Pub. L. 92–463), the Centers for Disease Status: The meeting will be closed to
Control and Prevention (CDC) the public in accordance with
announces a meeting for the initial provisions set forth in section 552b(c)(4)
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![31380 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
and (6), Title 5 U.S.C., and the whether the information will have mothers of case and control infants are
Determination of the Director, practical utility; (b) Evaluate the interviewed using a computer-assisted
Management Analysis and Services accuracy of the agencies estimate of the telephone interview.
Office, CDC, pursuant to Public Law 92– burden of the proposed collection of The results from NBDPS have
463. information, including the validity of improved understanding of the causes
Matters for Discussion: The meeting the methodology and assumptions used; of birth defects. Over 200 articles have
will include the initial review, (c) Enhance the quality, utility, and been written in professional journals
discussion, and evaluation of clarity of the information to be using the data from NBDPS, and BD–
applications received in response to collected; (d) Minimize the burden of STEPS data will soon be added to
‘‘Development and validation of the collection of information on those NBDPS data for analysis. The current
laboratory procedures using next who are to respond, including through BD–STEPS revision is a change in
generation sequencing technologies to the use of appropriate automated, proposed data collection. Specifically,
assess genes causing severe combined electronic, mechanical, or other the study will not ask BD–STEPS
immune deficiency (SCID) in state technological collection techniques or participants to participate in saliva
newborn screening laboratories’’, EH15– other forms of information technology, collection as originally planned, but we
002. e.g., permitting electronic submission of will add an opportunity for some
Contact Person for More Information: responses; and (e) Assess information participants to respond to an online
Jane Suen, Dr.P.H., M.S., Scientific collection costs. questionnaire, and we will also ask
Review Officer, CDC, 4770 Buford To request additional information on some participants for permission to
Highway, NE., Mailstop F63, Atlanta, the proposed project or to obtain a copy retrieve newborn bloodspots.
Georgia 30341–3724, Telephone (770) of the information collection plan and The BD–STEPS interview takes
488–4281. instruments, call (404) 639–7570 or approximately forty-five minutes to
The Director, Management Analysis send an email to omb@cdc.gov. Written complete. A maximum of 275
and Services Office, has been delegated comments and/or suggestions regarding interviews are planned per year per
the authority to sign Federal Register the items contained in this notice center, 200 cases and 75 controls. With
notices pertaining to announcements of should be directed to the Attention: seven centers planned, the maximum
meetings and other committee CDC Desk Officer, Office of Management interview burden for all centers
management activities, for both the and Budget, Washington, DC 20503 or combined would be approximately
Centers for Disease Control and by fax to (202) 395–5806. Written 1,444 hours. Mothers in five of the
Prevention and the Agency for Toxic comments should be received within 30 seven BD–STEPS Centers will also be
Substances and Disease Registry. days of this notice. asked to provide consent for the study
to access previously collected infant
Elaine L. Baker, Proposed Project bloodspots. It takes approximately 15
Director, Management Analysis and Services Birth Defects Study To Evaluate minutes to read, sign and return the
Office, Centers for Disease Control and Pregnancy exposureS (BD–STEPS) informed consent for retrieval of
Prevention. (formerly titled The National Birth bloodspots. For approximately one fifth
[FR Doc. 2015–13314 Filed 6–1–15; 8:45 am] Defects Prevention Study (NBDPS)), of participants, some medical records
BILLING CODE 4163–18–P (OMB 0920–0010, Expiration 01/31/ review will be conducted. The medical
2017)—Revision—National Center on records release form will take
Birth Defects and Developmental participants approximately 15 minutes
DEPARTMENT OF HEALTH AND Disabilities (NCBDDD), Centers for to read, sign and return. In addition, it
HUMAN SERVICES Disease Control and Prevention (CDC). will take approximately 30 minutes for
each medical record reviewer to
Centers for Disease Control and Background and Brief Description conduct the review and send the
Prevention CDC has been monitoring the medical record. Finally, the newly
[30Day–15–0010]
occurrence of serious birth defects and planned online questionnaire will be
genetic diseases in Atlanta since 1967 offered to approximately one third of
Agency Forms Undergoing Paperwork through the Metropolitan Atlanta participants who report certain
Reduction Act Review Congenital Defects Program (MACDP). occupations during the telephone
The MACDP is a population-based interview; these participants will be
The Centers for Disease Control and surveillance system for birth defects asked to complete additional
Prevention (CDC) has submitted the currently covering three counties in occupational questions via a Web site
following information collection request Metropolitan Atlanta. which will take approximately 20
to the Office of Management and Budget Since 1997, CDC has funded case- minutes to answer.
(OMB) for review and approval in control studies of major birth defects Information gathered from both the
accordance with the Paperwork that utilize existing birth defect interviews and the Deoxyribonucleic
Reduction Act of 1995. The notice for surveillance registries (including acid specimens has been and will
the proposed information collection is MACDP) to identify cases and study continue to be used to study
published to obtain comments from the birth defects causes in participating independent genetic and environmental
public and affected agencies. states/municipalities across the United factors as well as gene-environment
Written comments and suggestions States.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
interactions for a broad range of
from the public and affected agencies The current study, BD–STEPS, is a carefully classified birth defects.
concerning the proposed collection of case-control study that is similar to the This request is submitted to revise the
information are encouraged. Your previous CDC-funded birth defects case- previously estimated burden details and
comments should address any of the control study, NBDPS, which stopped to request OMB clearance for three
following: (a) Evaluate whether the interviewing participants in 2013. As additional years. The total estimated
proposed collection of information is with NBDPS, BD–STEPS control infants annual burden hours are 2,290.
necessary for the proper performance of are randomly selected from birth There are no costs to the respondents
the functions of the agency, including certificates or birth hospital records; other than their time.
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Document Created: 2015-12-15 15:12:20
Document Modified: 2015-12-15 15:12:20
| 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 | |
| Dates | 11:00 a.m.-3:00 p.m., EDT, June 25, 2015 (CLOSED). | |
| FR Citation | 80 FR 31379 |
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