80 FR 31380 - Agency Forms Undergoing Paperwork Reduction Act 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 | 31380-31381 | |
| FR Document | 2015-13385 |
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)] [Notices] [Pages 31380-31381] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13385] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-0010] 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 omb@cdc.gov. 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 Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS) (formerly titled The National Birth Defects Prevention Study (NBDPS)), (OMB 0920-0010, Expiration 01/31/2017)--Revision--National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC has been monitoring the occurrence of serious birth defects and genetic diseases in Atlanta since 1967 through the Metropolitan Atlanta Congenital Defects Program (MACDP). The MACDP is a population-based surveillance system for birth defects currently covering three counties in Metropolitan Atlanta. Since 1997, CDC has funded case-control studies of major birth defects that utilize existing birth defect surveillance registries (including MACDP) to identify cases and study birth defects causes in participating states/municipalities across the United States. The current study, BD-STEPS, is a case-control study that is similar to the previous CDC-funded birth defects case-control study, NBDPS, which stopped interviewing participants in 2013. As with NBDPS, BD-STEPS control infants are randomly selected from birth certificates or birth hospital records; mothers of case and control infants are interviewed using a computer-assisted telephone interview. The results from NBDPS have improved understanding of the causes of birth defects. Over 200 articles have been written in professional journals using the data from NBDPS, and BD-STEPS data will soon be added to NBDPS data for analysis. The current BD-STEPS revision is a change in proposed data collection. Specifically, the study will not ask BD-STEPS participants to participate in saliva collection as originally planned, but we will add an opportunity for some participants to respond to an online questionnaire, and we will also ask some participants for permission to retrieve newborn bloodspots. The BD-STEPS interview takes approximately forty-five minutes to complete. A maximum of 275 interviews are planned per year per center, 200 cases and 75 controls. With seven centers planned, the maximum interview burden for all centers combined would be approximately 1,444 hours. Mothers in five of the seven BD-STEPS Centers will also be asked to provide consent for the study to access previously collected infant bloodspots. It takes approximately 15 minutes to read, sign and return the informed consent for retrieval of bloodspots. For approximately one fifth of participants, some medical records review will be conducted. The medical records release form will take participants approximately 15 minutes to read, sign and return. In addition, it will take approximately 30 minutes for each medical record reviewer to conduct the review and send the medical record. Finally, the newly planned online questionnaire will be offered to approximately one third of participants who report certain occupations during the telephone interview; these participants will be asked to complete additional occupational questions via a Web site which will take approximately 20 minutes to answer. Information gathered from both the interviews and the Deoxyribonucleic acid specimens has been and will continue to be used to study independent genetic and environmental factors as well as gene- environment interactions for a broad range of carefully classified birth defects. This request is submitted to revise the previously estimated burden details and to request OMB clearance for three additional years. The total estimated annual burden hours are 2,290. There are no costs to the respondents other than their time. [[Page 31381]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Respondents Activity respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Mothers (interview)................... Telephone consent and BD- 1,925 1 45/60 STEPS questionnaire. Mothers (consent for bloodspot Written consent for 1,375 1 15/60 retrieval). bloodspot retrieval. Mothers (online occupational Online Occupational 642 1 20/60 questionnaire). Questionnaire. Mothers (consent for medical records Written release for 385 1 15/60 review). medical records review. Records reviewers (medical records Pulling and sending 385 1 30/60 review). records. ---------------------------------------------------------------------------------------------------------------- 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. 2015-13385 Filed 6-1-15; 8:45 am] BILLING CODE 4163-18-P
![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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![Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices 31381
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Respondents Activity responses per
respondents response
respondent (in hours)
Mothers (interview) ......................................... Telephone consent and BD–STEPS ques- 1,925 1 45/60
tionnaire.
Mothers (consent for bloodspot retrieval) ....... Written consent for bloodspot retrieval .......... 1,375 1 15/60
Mothers (online occupational questionnaire) .. Online Occupational Questionnaire ............... 642 1 20/60
Mothers (consent for medical records review) Written release for medical records review ... 385 1 15/60
Records reviewers (medical records review) Pulling and sending records .......................... 385 1 30/60
Leroy A. Richardson, of the meeting will be included in the Atlanta, Georgia 30333, telephone 404/
Chief, Information Collection Review Office, official record of the meeting. 639–8836; Email ACIP@CDC.GOV
Office of Scientific Integrity, Office of the The meeting will be webcast live via The Director, Management Analysis
Associate Director for Science, Office of the the World Wide Web; for instructions and Services Office, has been delegated
Director, Centers for Disease Control and and more information on ACIP please the authority to sign Federal Register
Prevention. visit the ACIP Web site: http:// notices pertaining to announcements of
[FR Doc. 2015–13385 Filed 6–1–15; 8:45 am] www.cdc.gov/vaccines/acip/index.html meetings and other committee
BILLING CODE 4163–18–P Purpose: The committee is charged management activities, for both the
with advising the Director, CDC, on the Centers for Disease Control and
appropriate use of immunizing agents. Prevention and the Agency for Toxic
DEPARTMENT OF HEALTH AND In addition, under 42 U.S.C. 1396s, the Substances and Disease Registry.
HUMAN SERVICES committee is mandated to establish and
periodically review and, as appropriate, Elaine L. Baker,
Centers for Disease Control and revise the list of vaccines for Director, Management Analysis and Services
Prevention administration to vaccine-eligible Office, Centers for Disease Control and
Prevention.
Advisory Committee on Immunization children through the Vaccines for
Children (VFC) program, along with [FR Doc. 2015–13312 Filed 6–1–15; 8:45 am]
Practices
schedules regarding the appropriate BILLING CODE 4160–18–P
In accordance with section 10(a)(2) of periodicity, dosage, and
the Federal Advisory Committee Act contraindications applicable to the
(Pub. L. 92–463), the Centers for Disease vaccines. Further, under provisions of DEPARTMENT OF HEALTH AND
Control and Prevention (CDC) announce the Affordable Care Act, at section 2713 HUMAN SERVICES
the following federal advisory of the Public Health Service Act, Centers for Disease Control and
committee meeting. immunization recommendations of the
Times and dates: Prevention
ACIP that have been adopted by the
8:00 a.m.–5:15 p.m., June 24, 2015 Director of the Centers for Disease Disease, Disability, and Injury
8:30 a.m.–3:30 p.m., June 25, 2015 Control and Prevention must be covered Prevention and Control Special
Place: CDC, Tom Harkin Global by applicable health plans. Emphasis Panel (SEP): Initial Review
Communications Center, 1600 Clifton Matters for discussion: The agenda
Road NE., Building 19, Kent ‘‘Oz’’ will include discussions on: In accordance with section 10(a)(2) of
Nelson Auditorium, Atlanta, Georgia Meningococcal vaccines; general the Federal Advisory Committee Act
30333 recommendations; human (Pub. L. 92–463), the Centers for Disease
Status: Open to the public, limited papillomavirus vaccines; influenza; Control and Prevention (CDC)
only by the space available. Time will influenza A(H5N1) vaccine, tetanus, announces a meeting for the initial
be available for public comment. The diphtheria, and acellular pertussis review of applications in response to PA
public is welcome to submit written (Tdap) vaccine; combination vaccines; 07–318, NIOSH Member Conflict
comments in advance of the meeting. smallpox vaccine in laboratory Review.
Comments should be submitted in personnel; pneumococcal vaccines; Time and date: 1:00 p.m.–4:00 p.m.,
writing by email to the contact person child/adolescent immunization EST, June 25, 2015 (Closed)
listed below. The deadline for receipt is schedule; herpes zoster vaccines; Place: Teleconference.
June 22, 2015. All requests must contain Japanese encephalitis vaccine and Status: The meeting will be closed to
the name, address, and organizational vaccine supply. Recommendation votes the public in accordance with
affiliation of the speaker, as well as the are scheduled for meningococcal provisions set forth in section 552b(c)
topic being addressed. Written vaccines, influenza, influenza A (H5N1), (4) and (6), Title 5 U.S.C., and the
comments should not exceed one single- smallpox vaccine in laboratory Determination of the Director,
spaced typed page in length and personnel, general recommendations Management Analysis and Services
delivered in three minutes or less.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
and pneumococcal vaccines. A Vaccines Office, CDC, pursuant to Public Law 92–
Please note that the public comment for Children (VCF) vote is scheduled for 463.
period may end before the time meningococcal vaccines. Matters for discussion: The meeting
indicated, following the last call for Agenda items are subject to change as will include the initial review,
comments. Members of the public who priorities dictate. discussion, and evaluation of
wish to provide public comments Contact person for more information: applications received in response to
should plan to attend the public Stephanie Thomas, National Center for ‘‘NIOSH Member Conflict PA 07–318.’’
comment session at the start time listed. Immunization and Respiratory Diseases, Contact person for more information:
Written comments received in advance CDC, 1600 Clifton Road NE., MS–A27, Nina Turner, Ph.D., Scientific Review
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Document Created: 2015-12-15 15:11:53
Document Modified: 2015-12-15 15:11:53
| Category | Regulatory Information | |
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| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| FR Citation | 80 FR 31380 |
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