81 FR 71736 - Proposed Information Collection Activity; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 81, Issue 201 (October 18, 2016)
Administration for Children and Families
Federal Register Volume 81, Issue 201 (October 18, 2016)
| Page Range | 71736-71737 | |
| FR Document | 2016-25120 |
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)] [Notices] [Pages 71736-71737] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25120] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Title: Renewal of Office of Community Services (OCS) Community Economic Development (CED) Standard Reporting Format. OMB No.: 0970-0386. Description: The Office of Community Services (OCS) will continue collecting key information about projects funded through the Community Economic Development (CED) program. The legislative requirement for this program is in Title IV of the Community Opportunities, Accountability and Training and Educational Services Act (COATS Human Services Reauthorization Act) of October 27, 1998, Public Law 105-285, section 680(b) as amended. The reporting format, Performance Progress Report (PPR), collects information concerning the outcomes and management of CED projects. OCS will use the data to critically review the overall design and effectiveness of the program. The PPR will continue to be administered to all active grantees of the CED program. Grantees will be required to use this reporting tool for their semi-annual reports to be submitted twice a year. The current PPR replaced both the annual questionnaire and other semi-annual reporting formats, which resulted in an overall reduction in burden for the grantees while significantly improving the quality of the data collected by OCS. OCS seeks to renew this PPR to continue to collect quality data from grantees. To ensure the burden on grantees is not increased, but that the information collected demonstrates the full impact of the program, OCS has conducted an in-depth review to remove indicators that are not being used; add indicators that will allow OCS to better demonstrate the impact of the program; and clarify language of some indicators to reduce grantee confusion. Based on this review, proposed changes to the CED PPR are minimal and focused on clarifying language, removing outdated indicators, and gathering minimal additional data that will not increase the burden on grantees. These measures will result in a stronger and streamlined CED PPR that will allow for the following: --More clarity for grantees and ability to avoid confusion around what data should be provided. --Increased consistency across data. --Ability for OCS and grantees to better demonstrate the impact of these projects. A summary of all proposed changes can be provided upon request. Respondents: Active CED Grantees Annual Burden Estimates ---------------------------------------------------------------------------------------------------------------- Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- PPR for Current OCS-CED Grantees............ 170 2 1.5 510 ---------------------------------------------------------------------------------------------------------------- Estimated Total Annual Burden Hours: In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: [email protected]. All requests should be identified by the title of the information collection. [[Page 71737]] The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016-25120 Filed 10-17-16; 8:45 am] BILLING CODE 4184-01-P
![71736 Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices
the Food and Drug Administration. The Administration, and parent and health Reauthorization Act) of October 27,
law also requires that the information care provider groups. 1998, Public Law 105–285, section
contained in the materials be based on We invite written comment on the 680(b) as amended. The reporting
available data and information, be proposed revised vaccine information format, Performance Progress Report
presented in understandable terms, and materials entitled ‘‘MMR Vaccine (PPR), collects information concerning
include: (Measles, Mumps, and Rubella): What the outcomes and management of CED
(1) A concise description of the You Need to Know’’ and ‘‘MMRV projects. OCS will use the data to
benefits of the vaccine, Vaccine (Measles, Mumps, Rubella, and critically review the overall design and
(2) A concise description of the risks Varicella): What You Need to Know.’’ effectiveness of the program.
associated with the vaccine, Copies of the proposed vaccine The PPR will continue to be
(3) A statement of the availability of information materials are available at administered to all active grantees of the
the National Vaccine Injury http://www.regulations.gov (see Docket CED program. Grantees will be required
Compensation Program, and Number CDC–2016–0094). Comments to use this reporting tool for their semi-
(4) Such other relevant information as submitted will be considered in annual reports to be submitted twice a
may be determined by the Secretary. finalizing these materials. When the year. The current PPR replaced both the
The vaccines initially covered under final materials are published in the annual questionnaire and other semi-
the National Vaccine Injury Federal Register, the notice will include annual reporting formats, which
Compensation Program were diphtheria, an effective date for their mandatory resulted in an overall reduction in
tetanus, pertussis, measles, mumps, use. burden for the grantees while
rubella and poliomyelitis vaccines. Dated: October 13, 2016. significantly improving the quality of
Since April 15, 1992, any health care Sandra Cashman, the data collected by OCS. OCS seeks to
provider in the United States who Executive Secretary, Centers for Disease
renew this PPR to continue to collect
intends to administer one of these Control and Prevention. quality data from grantees. To ensure
covered vaccines is required to provide [FR Doc. 2016–25144 Filed 10–17–16; 8:45 am]
the burden on grantees is not increased,
copies of the relevant vaccine but that the information collected
BILLING CODE 4163–18–P
information materials prior to demonstrates the full impact of the
administration of any of these vaccines. program, OCS has conducted an in-
Since then, the following vaccines have DEPARTMENT OF HEALTH AND depth review to remove indicators that
been added to the National Vaccine HUMAN SERVICES are not being used; add indicators that
Injury Compensation Program, requiring will allow OCS to better demonstrate
use of vaccine information materials for Administration for Children and the impact of the program; and clarify
them as well: Hepatitis B, Haemophilus Families language of some indicators to reduce
influenzae type b (Hib), varicella grantee confusion. Based on this review,
(chickenpox), pneumococcal conjugate, Proposed Information Collection proposed changes to the CED PPR are
rotavirus, hepatitis A, meningococcal, Activity; Comment Request minimal and focused on clarifying
human papillomavirus (HPV), and language, removing outdated indicators,
Proposed Projects:
seasonal influenza vaccines. Title: Renewal of Office of and gathering minimal additional data
Instructions for use of the vaccine Community Services (OCS) Community that will not increase the burden on
information materials are found on the Economic Development (CED) Standard grantees. These measures will result in
CDC Web site at: http://www.cdc.gov/ Reporting Format. a stronger and streamlined CED PPR
vaccines/hcp/vis/index.html. OMB No.: 0970–0386. that will allow for the following:
HHS/CDC is proposing updated Description: The Office of Community —More clarity for grantees and ability to
versions of the MMR (measles, mumps, Services (OCS) will continue collecting avoid confusion around what data
and rubella) and MMRV (measles, key information about projects funded should be provided.
mumps, rubella, and varicella) vaccine through the Community Economic —Increased consistency across data.
information statements. Development (CED) program. The —Ability for OCS and grantees to better
The vaccine information materials legislative requirement for this program demonstrate the impact of these
referenced in this notice are being is in Title IV of the Community projects.
developed in consultation with the Opportunities, Accountability and A summary of all proposed changes
Advisory Commission on Childhood Training and Educational Services Act can be provided upon request.
Vaccines, the Food and Drug (COATS Human Services Respondents: Active CED Grantees
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
PPR for Current OCS–CED Grantees ............................................................. 170 2 1.5 510
Estimated Total Annual Burden on the specific aspects of the and Evaluation, 330 C Street SW.,
Lhorne on DSK30JT082PROD with NOTICES
Hours: information collection described above. Washington DC 20201. Attn: ACF
In compliance with the requirements Copies of the proposed collection of Reports Clearance Officer. Email
of the Paperwork Reduction Act of 1995 information can be obtained and address: infocollection@acf.hhs.gov. All
(Pub. L. 104–13, 44 U.S.C. Chap 35), the comments may be forwarded by writing requests should be identified by the title
Administration for Children and to the Administration for Children and of the information collection.
Families is soliciting public comment Families, Office of Planning, Research
VerDate Sep<11>2014 13:19 Oct 17, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1](https://thefederalregister.org/doc/81_FR_71937/page/1.svg)
![Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices 71737
The Department specifically requests • Federal eRulemaking Portal: http:// except in accordance with 21 CFR 10.20
comments on: (a) Whether the proposed www.regulations.gov. Follow the and other applicable disclosure law.
collection of information is necessary instructions for submitting comments to Comments Submitted by Other
for the proper performance of the submit your request for a hearing. Interested Parties: For all comments
functions of the agency, including Comments submitted electronically to submitted by other interested parties,
whether the information shall have http://www.regulations.gov, including submit comments as follows:
practical utility; (b) the accuracy of the any attachments to the request for
hearing, will be posted to the docket Electronic Submissions
agency’s estimate of the burden of the
proposed collection of information; (c) unchanged. Submit electronic comments in the
the quality, utility, and clarity of the Written/Paper Submissions following way:
information to be collected; and (d) • Federal eRulemaking Portal: http://
ways to minimize the burden of the Submit written/paper submissions as www.regulations.gov. Follow the
collection of information on follows: instructions for submitting comments.
respondents, including through the use • Mail/Hand delivery/Courier (for Comments submitted electronically,
of automated collection techniques or written/paper submissions): Division of including attachments, to http://
other forms of information technology. Dockets Management (HFA–305), Food www.regulations.gov will be posted to
Consideration will be given to and Drug Administration, 5630 Fishers the docket unchanged. Because your
comments and suggestions submitted Lane, Rm. 1061, Rockville, MD 20852.
comment will be made public, you are
• Because your request for a hearing
within 60 days of this publication. solely responsible for ensuring that your
will be made public, you are solely
Robert Sargis, responsible for ensuring that your comment does not include any
request does not include any confidential information that you or a
Reports Clearance Officer.
confidential information that you may third party may not wish to be posted,
[FR Doc. 2016–25120 Filed 10–17–16; 8:45 am]
not wish to be publicly posted, such as such as medical information, your or
BILLING CODE 4184–01–P anyone else’s Social Security number, or
confidential business information, e.g., a
manufacturing process. The request for confidential business information, such
a hearing must include the Docket No. as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND that if you include your name, contact
HUMAN SERVICES FDA–2016–N–3118 for ‘‘Mallinckrodt
Pharmaceuticals; Proposal to Withdraw information, or other information that
Food and Drug Administration Approval of an Abbreviated New Drug identifies you in the body of your
Application for Extended-Release comments, that information will be
[Docket No. FDA–2016–N–3118] posted on http://www.regulations.gov.
Methylphenidate Tablets; Opportunity
for a Hearing.’’ The request for a hearing • If you want to submit a comment
Mallinckrodt Pharmaceuticals; with confidential information that you
Proposal To Withdraw Approval of an will be placed in the docket and
publicly viewable at http:// do not wish to be made available to the
Abbreviated New Drug Application for public, submit the comment as a
Extended-Release Methylphenidate www.regulations.gov or at the Division
of Dockets Management between 9 a.m. written/paper submission and in the
Tablets; Opportunity for a Hearing manner detailed (see ‘‘Written/Paper
and 4 p.m., Monday through Friday.
AGENCY: Food and Drug Administration, Mallinckrodt Pharmaceuticals may Submissions’’ and ‘‘Instructions’’).
HHS. submit all data and analysis upon which Written/Paper Submissions
ACTION: Notice. the request for a hearing relies in the
same manner as the request for a Submit written/paper submissions as
SUMMARY: The Food and Drug hearing except as follows: follows:
Administration’s (FDA or Agency) • Confidential Submissions—To • Mail/Hand delivery/Courier (for
Center for Drug Evaluation and Research submit any data analyses with written/paper submissions): Division of
(CDER) is proposing to withdraw confidential information that you do not Dockets Management (HFA–305), Food
approval of an abbreviated new drug wish to be made publicly available, and Drug Administration, 5630 Fishers
application (ANDA) for submit your data and analyses only as Lane, Rm. 1061, Rockville, MD 20852.
methylphenidate hydrochloride (HCl) a written/paper submission. You should • For written/paper comments
extended-release (ER) tablets and is submit two copies total of all data and submitted to the Division of Dockets
announcing an opportunity for the analyses. One copy will include the Management, FDA will post your
holder of the ANDA to request a hearing information you claim to be confidential comment, as well as any attachments,
on this proposal. with a heading or cover note that states except for information submitted,
DATES: Mallinckrodt Pharmaceuticals ‘‘THIS DOCUMENT CONTAINS marked and identified, as confidential,
may submit a request for a hearing by CONFIDENTIAL INFORMATION.’’ The if submitted as detailed in
November 17, 2016. Submit all data, Agency will review this copy, including ‘‘Instructions.’’
information, and analyses upon which the claimed confidential information, in Instructions: All submissions received
the request for a hearing relies by its consideration of any decisions on must include the Docket No. FDA–
December 19, 2016. Submit written or this matter. The second copy, which 2016–N–3118 for ‘‘Mallinckrodt
electronic comments by December 19, will have the claimed confidential Pharmaceuticals; Proposal to Withdraw
2016. information redacted/blacked out, will Approval of an Abbreviated New Drug
ADDRESSES: The request for a hearing be available for public viewing and Application for Extended-Release
Lhorne on DSK30JT082PROD with NOTICES
may be submitted by Mallinckrodt posted on http://www.regulations.gov or Methylphenidate Tablets; Opportunity
Pharmaceuticals by either of the available at the Division of Dockets for a Hearing.’’ Received comments will
following methods: Management between 9 a.m. and 4 p.m., be placed in the docket and, except for
Monday through Friday. Submit both those submitted as ‘‘Confidential
Electronic Submissions copies to the Division of Dockets Submissions,’’ publicly viewable at
Submit electronic comments in the Management. Any information marked http://www.regulations.gov or at the
following way: as ‘‘confidential’’ will not be disclosed Division of Dockets Management
VerDate Sep<11>2014 13:19 Oct 17, 2016 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1](https://thefederalregister.org/doc/81_FR_71937/page/2.svg)
Document Created: 2016-10-17 23:52:28
Document Modified: 2016-10-17 23:52:28
| 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 71736 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR