81 FR 71505 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 200 (October 17, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 200 (October 17, 2016)
| Page Range | 71505-71506 | |
| FR Document | 2016-25061 |
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)] [Notices] [Pages 71505-71506] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25061] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-16PA] 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]. Direct written comments and/or suggestions regarding the items contained in this notice 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 Study to Explore Early Development (SEED) Phase 3--New--National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description Autism spectrum disorders (ASD) are a group of neurodevelopmental disorders characterized by qualitative impairments in social interaction and communication and stereotyped behaviors and interests. Recent systematic population surveys and routine monitoring systems in the U.S. and other countries indicate the prevalence to be 1-2%. Apart from the identification of some rare genetic conditions that are commonly associated with autism, causal mechanisms for the disorder largely remain unknown. The Children's Health Act of 2000 mandated CDC to establish autism surveillance and research programs to address the number, incidence, and causes of autism and related developmental disabilities. Under the provisions of this act, NCBDDD funded five Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) through program announcements in FY2001 and FY2002; CDC's NCBDDD served as the sixth CADDRE site. For the first funding cycle (2001-2006), each CADDRE grantee had three core objectives: To develop a protocol for a multi-site collaborative epidemiologic study focused on autism (which was eventually named the Study to Explore Early Development [SEED]); to conduct surveillance of autism and other developmental disabilities; and to conduct site-specific investigator-initiated studies on autism. In FY 2006, through a second CADDRE funding cycle, five grantees were awarded. The CADDRE activities for the second funding cycle (2006-2011) were limited to implementation of the first phase of SEED (subsequently known as SEED 1). CDC served as the sixth CADDRE SEED 1 site during this period. A second phase of SEED (SEED 2) was funded under a third funding cycle (2011-2016). Five CADDRE grantees received the awards. Again, CDC served as the sixth SEED 2 site. A third phase of SEED (SEED 3) was funded in July 2016. Five extramural sites were funded. Together with the CDC, they will implement the SEED 3 collaborative protocol. The SEED 3 protocol for identification of study participants, recruitment, and study data collection flow will be similar to the protocols for SEED 1 and 2. However, while all SEED phases have the same research goals and the same basic study design, data collection has been greatly streamlined and revised between SEED 1, SEED 2, and SEED 3. Many study instruments and data collection components included in the SEED 1 protocol are not included in the SEED 3 protocol; two instruments included in the SEED 3 protocol were developed subsequent to SEED 1 to capture an abbreviated version of information that had been included on some of the discontinued SEED 1 forms and to capture some additional information overlooked in the SEED 1 protocol; and instruments included in all phases of SEED underwent review and minor revision subsequent to SEED 1 to address ambiguities and difficulties experienced during SEED 1 data collection. Implementing this phase of SEED will increase the total SEED pooled sample size for investigation of high priority hypotheses. Maintaining the same basic study design and general protocol integrity will ensure that data pooling can be achieved across SEED phases. Families will be identified from each of the 3 groups: Autism Spectrum Disorder (ASD), other developmental delay or disorder comparison group (DD), and a second comparison group of children randomly drawn from the entire study cohort population (POP). It is expected that the 6 SEED 3 study sites will have a total of 2,106 children enroll and complete the study protocol. The data collection process will take approximately 9 hours 10 minutes (ASD group); 5 hours 30 minutes (POP group); 2 hours 45 minutes (DD group) to complete, which includes (1) maternal telephone interview with questions about maternal reproductive history and [[Page 71506]] pregnancy with the index child, (2) parent-completed questionnaires about parental and child health and child development, (3) in-person child developmental evaluation, (4) maternal and child anthropometry measurements, and (5) biosampling from biological parents and child. There are no costs to participants other than their time. The total estimated annual burden hours are 7,118. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Mother All potential participants sent Invitation Packet/ 1,718 1 10/60 mailing. Response Card. Mother Potentially eligible with Invitation Call Script 859 1 30/60 contact by study staff. and Social Communication Questionnaire. Mother Eligible, consented, and Enrollment Packet....... 469 1 20/60 enrolled; assigned to the ASD workflow based on enrollment intake. Mother Completed this study step...... Follow-up Phone Call 422 1 15/60 Script and Pregnancy Reference Form. Maternal Interview Call. 422 1 1 Self-Administered Forms. 375 1 105/60 Follow-up Call 2........ 375 1 20/60 Clinic/Home Visit-- 328 1 225/60 Developmental Assessment. Father Completed this study step...... Clinic/Home Visit-- 164 1 15/60 Saliva Collection (optional--on own). Child Completed this study step....... Clinic/Home Visit-- 328 1 135/60 Developmental Assessment. Mother All potential participants sent Invitation Packet/ 1,466 1 10/60 mailing. Response Card. Mother Potentially eligible with Invitation Call Script 733 1 30/60 contact by study staff. and Social Communication Questionnaire. Mother Eligible, consented, and Enrollment Packet....... 334 1 20/60 enrolled; assigned to the POP workflow based on enrollment intake. Mother Completed this study step...... Follow-up Phone Call 301 1 15/60 Script and Pregnancy Reference Form. Maternal Interview Call. 301 1 1 Self-Administered Forms. 267 1 105/60 Follow-up Call 2........ 267 1 20/60 Clinic/Home Visit-- 234 1 50/60 Developmental Assessment. Father Completed this study step...... Clinic/Home Visit-- 117 1 15/60 Saliva Collection (optional--on own). Child Completed this study step....... Clinic/Home Visit-- 234 1 90/60 Developmental Assessment. Mother All potential participants sent Invitation Packet/ 641 1 10/60 mailing. Response Card. Mother Potentially eligible with Invitation Call Script 321 1 30/60 contact by study staff. and Social Communication Questionnaire. Mother Eligible, consented, and Enrollment Packet....... 175 1 20/60 enrolled; assigned to the DD workflow based on enrollment intake. Mother Completed this study step...... Follow-up Phone Call 158 1 15/60 Script and Pregnancy Reference Form. Maternal Interview Call. 158 1 1 Self-Administered Forms. 140 1 55/60 Follow-up Call 2........ 140 1 20/60 ---------------------------------------------------------------------------------------------------------------- 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. 2016-25061 Filed 10-14-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71505
in accordance with the Freedom of the collection of information on those initiated studies on autism. In FY 2006,
Information Act and, if deemed who are to respond, including through through a second CADDRE funding
appropriate, will redact such the use of appropriate automated, cycle, five grantees were awarded. The
information. Disclosures of information electronic, mechanical, or other CADDRE activities for the second
concerning third party medical technological collection techniques or funding cycle (2006–2011) were limited
information will be redacted. other forms of information technology, to implementation of the first phase of
Contact person for more information: e.g., permitting electronic submission of SEED (subsequently known as SEED 1).
Paul J. Middendorf, Ph.D., Designated responses; and (e) Assess information CDC served as the sixth CADDRE SEED
Federal Officer, NIOSH, CDC, 2400 collection costs. 1 site during this period. A second
Century Parkway NE., Mail Stop E–20, To request additional information on phase of SEED (SEED 2) was funded
Atlanta, Georgia 30345, telephone 1 the proposed project or to obtain a copy under a third funding cycle (2011–
(888) 982–4748; email: wtc-stac@ of the information collection plan and 2016). Five CADDRE grantees received
cdc.gov. instruments, call (404) 639–7570 or the awards. Again, CDC served as the
The Director, Management Analysis send an email to omb@cdc.gov. Direct sixth SEED 2 site.
and Services Office, has been delegated written comments and/or suggestions A third phase of SEED (SEED 3) was
the authority to sign Federal Register regarding the items contained in this funded in July 2016. Five extramural
notices pertaining to announcements of notice to the Attention: CDC Desk sites were funded. Together with the
meetings and other committee Officer, Office of Management and CDC, they will implement the SEED 3
management activities, for both the Budget, Washington, DC 20503 or by fax collaborative protocol. The SEED 3
Centers for Disease Control and to (202) 395–5806. Written comments protocol for identification of study
Prevention, and the Agency for Toxic should be received within 30 days of participants, recruitment, and study
Substances and Disease Registry. this notice. data collection flow will be similar to
the protocols for SEED 1 and 2.
Elaine L. Baker, Proposed Project However, while all SEED phases have
Director, Management Analysis and Services Study to Explore Early Development the same research goals and the same
Office, Centers for Disease Control and (SEED) Phase 3—New—National Center basic study design, data collection has
Prevention. on Birth Defects and Developmental been greatly streamlined and revised
[FR Doc. 2016–25039 Filed 10–14–16; 8:45 am] Disabilities (NCBDDD), Centers for between SEED 1, SEED 2, and SEED 3.
BILLING CODE 4163–18–P Disease Control and Prevention (CDC). Many study instruments and data
collection components included in the
Background and Brief Description
SEED 1 protocol are not included in the
DEPARTMENT OF HEALTH AND Autism spectrum disorders (ASD) are SEED 3 protocol; two instruments
HUMAN SERVICES a group of neurodevelopmental included in the SEED 3 protocol were
disorders characterized by qualitative developed subsequent to SEED 1 to
Centers for Disease Control and impairments in social interaction and capture an abbreviated version of
Prevention communication and stereotyped information that had been included on
[30Day–17–16PA]
behaviors and interests. Recent some of the discontinued SEED 1 forms
systematic population surveys and and to capture some additional
Agency Forms Undergoing Paperwork routine monitoring systems in the U.S. information overlooked in the SEED 1
Reduction Act Review and other countries indicate the protocol; and instruments included in
prevalence to be 1–2%. Apart from the all phases of SEED underwent review
The Centers for Disease Control and identification of some rare genetic and minor revision subsequent to SEED
Prevention (CDC) has submitted the conditions that are commonly 1 to address ambiguities and difficulties
following information collection request associated with autism, causal experienced during SEED 1 data
to the Office of Management and Budget mechanisms for the disorder largely collection. Implementing this phase of
(OMB) for review and approval in remain unknown. SEED will increase the total SEED
accordance with the Paperwork The Children’s Health Act of 2000 pooled sample size for investigation of
Reduction Act of 1995. The notice for mandated CDC to establish autism high priority hypotheses. Maintaining
the proposed information collection is surveillance and research programs to the same basic study design and general
published to obtain comments from the address the number, incidence, and protocol integrity will ensure that data
public and affected agencies. causes of autism and related pooling can be achieved across SEED
Written comments and suggestions developmental disabilities. Under the phases.
from the public and affected agencies provisions of this act, NCBDDD funded Families will be identified from each
concerning the proposed collection of five Centers for Autism and of the 3 groups: Autism Spectrum
information are encouraged. Your Developmental Disabilities Research Disorder (ASD), other developmental
comments should address any of the and Epidemiology (CADDRE) through delay or disorder comparison group
following: (a) Evaluate whether the program announcements in FY2001 and (DD), and a second comparison group of
proposed collection of information is FY2002; CDC’s NCBDDD served as the children randomly drawn from the
necessary for the proper performance of sixth CADDRE site. entire study cohort population (POP). It
the functions of the agency, including For the first funding cycle (2001– is expected that the 6 SEED 3 study sites
whether the information will have 2006), each CADDRE grantee had three will have a total of 2,106 children enroll
practical utility; (b) Evaluate the core objectives: To develop a protocol and complete the study protocol. The
jstallworth on DSK7TPTVN1PROD with NOTICES
accuracy of the agencies estimate of the for a multi-site collaborative data collection process will take
burden of the proposed collection of epidemiologic study focused on autism approximately 9 hours 10 minutes (ASD
information, including the validity of (which was eventually named the Study group); 5 hours 30 minutes (POP group);
the methodology and assumptions used; to Explore Early Development [SEED]); 2 hours 45 minutes (DD group) to
(c) Enhance the quality, utility, and to conduct surveillance of autism and complete, which includes (1) maternal
clarity of the information to be other developmental disabilities; and to telephone interview with questions
collected; (d) Minimize the burden of conduct site-specific investigator- about maternal reproductive history and
VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1](https://thefederalregister.org/doc/81_FR_71705/page/1.svg)
![71506 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
pregnancy with the index child, (2) developmental evaluation, (4) maternal There are no costs to participants
parent-completed questionnaires about and child anthropometry measurements, other than their time. The total
parental and child health and child and (5) biosampling from biological estimated annual burden hours are
development, (3) in-person child parents and child. 7,118.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Mother All potential participants sent mailing ............... Invitation Packet/Response Card .... 1,718 1 10/60
Mother Potentially eligible with contact by study staff .. Invitation Call Script and Social 859 1 30/60
Communication Questionnaire.
Mother Eligible, consented, and enrolled; assigned to Enrollment Packet ............................ 469 1 20/60
the ASD workflow based on enrollment intake.
Mother Completed this study step ................................ Follow-up Phone Call Script and 422 1 15/60
Pregnancy Reference Form.
Maternal Interview Call .................... 422 1 1
Self-Administered Forms ................. 375 1 105/60
Follow-up Call 2 ............................... 375 1 20/60
Clinic/Home Visit—Developmental 328 1 225/60
Assessment.
Father Completed this study step ................................. Clinic/Home Visit—Saliva Collection 164 1 15/60
(optional—on own).
Child Completed this study step ................................... Clinic/Home Visit—Developmental 328 1 135/60
Assessment.
Mother All potential participants sent mailing ............... Invitation Packet/Response Card .... 1,466 1 10/60
Mother Potentially eligible with contact by study staff .. Invitation Call Script and Social 733 1 30/60
Communication Questionnaire.
Mother Eligible, consented, and enrolled; assigned to Enrollment Packet ............................ 334 1 20/60
the POP workflow based on enrollment intake.
Mother Completed this study step ................................ Follow-up Phone Call Script and 301 1 15/60
Pregnancy Reference Form.
Maternal Interview Call .................... 301 1 1
Self-Administered Forms ................. 267 1 105/60
Follow-up Call 2 ............................... 267 1 20/60
Clinic/Home Visit—Developmental 234 1 50/60
Assessment.
Father Completed this study step ................................. Clinic/Home Visit—Saliva Collection 117 1 15/60
(optional—on own).
Child Completed this study step ................................... Clinic/Home Visit—Developmental 234 1 90/60
Assessment.
Mother All potential participants sent mailing ............... Invitation Packet/Response Card .... 641 1 10/60
Mother Potentially eligible with contact by study staff .. Invitation Call Script and Social 321 1 30/60
Communication Questionnaire.
Mother Eligible, consented, and enrolled; assigned to Enrollment Packet ............................ 175 1 20/60
the DD workflow based on enrollment intake.
Mother Completed this study step ................................ Follow-up Phone Call Script and 158 1 15/60
Pregnancy Reference Form.
Maternal Interview Call .................... 158 1 1
Self-Administered Forms ................. 140 1 55/60
Follow-up Call 2 ............................... 140 1 20/60
Leroy A. Richardson, DEPARTMENT OF HEALTH AND opportunity for public comment on the
Chief, Information Collection Review Office, HUMAN SERVICES proposed collection of certain
Office of Scientific Integrity, Office of the information by the Agency. Under the
Associate Director for Science, Office of the Food and Drug Administration Paperwork Reduction Act of 1995 (the
Director, Centers for Disease Control and PRA), Federal Agencies are required to
Prevention. [Docket No. FDA–2007–N–0037] publish notice in the Federal Register
[FR Doc. 2016–25061 Filed 10–14–16; 8:45 am] concerning each proposed collection of
Agency Information Collection
BILLING CODE 4163–18–P
Activities; Proposed Collection; information, including each proposed
Comment Request; Animal Drug User extension of an existing collection of
jstallworth on DSK7TPTVN1PROD with NOTICES
Fee Act Waivers and Reductions information, and to allow 60 days for
public comment in response to the
AGENCY: Food and Drug Administration, notice. This notice solicits comments on
HHS. the paperwork burden of requesting a
ACTION: Notice. waiver or reduction of fees under
Animal Drug User Fee Act (ADUFA).
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1](https://thefederalregister.org/doc/81_FR_71705/page/2.svg)
Document Created: 2016-10-15 01:52:19
Document Modified: 2016-10-15 01:52:19
| 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 | 81 FR 71505 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR