80 FR 66905 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 80, Issue 210 (October 30, 2015)
Administration for Children and Families
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66905-66906 | |
| FR Document | 2015-27666 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Notices] [Pages 66905-66906] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27666] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Administration for Native Americans Annual Data Collection (Annual Data Report). OMB No.: New collection. Description: Content and formatting changes are being made to the Objective Progress Report (OPR). Content changes are being made to the OPR, now known as the Annual Data Report (ADR) previously approved under information collection OMB No. 0980-0204. ANA has determined that the requirement for ANA grantees to submit information about the project activities on quarterly basis creates undue burden for Grantees. Therefore, ANA has reformatted the OPR to require Grantees submit an annual report instead of quarterly report when reporting on partnerships, youth and elder engagement, impact indicators, community involvement etc. This will reduce the administrative burden on Grantees, especially the smaller organizations. The majority of content being requested from the grantees essentially remain same except for the frequency of reporting. The other sections of the document with reference to ``quarterly'' information will be changed to reflect the shift from four-times a year reporting requirement to once per year and once at the end of the project period. Respondents: Tribal Government, Native non-profit organizations, Tribal Colleges & Universities receiving ANA funding. Annual Burden Estimates The following is the hour of burden estimate for this information collection: ---------------------------------------------------------------------------------------------------------------- Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- ADR......................................... 275 2 2 275 ---------------------------------------------------------------------------------------------------------------- [[Page 66906]] Estimated Total Annual Burden Hours: 275. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015-27666 Filed 10-29-15; 8:45 am] BILLING CODE 4184-01-P
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices 66905
To obtain copies of a supporting Satisfaction Surveys; Use: This Dated: October 26, 2015.
statement and any related forms for the collection of information is necessary to William N. Parham, III,
proposed collection(s) summarized in enable the Agency to garner customer Director, Paperwork Reduction Staff, Office
this notice, you may make your request and stakeholder feedback in an efficient, of Strategic Operations and Regulatory
using one of following: timely manner, in accordance with our Affairs.
1. Access CMS’ Web site address at commitment to improving service [FR Doc. 2015–27619 Filed 10–29–15; 8:45 am]
http://www.cms.hhs.gov/ delivery. The information collected BILLING CODE 4120–01–P
PaperworkReductionActof1995. from our customers and stakeholders
2. Email your request, including your will help ensure that users have an
address, phone number, OMB number, effective, efficient, and satisfying DEPARTMENT OF HEALTH AND
and CMS document identifier, to experience with the Agency’s programs. HUMAN SERVICES
Paperwork@cms.hhs.gov. This feedback will provide insights into
3. Call the Reports Clearance Office at customer or stakeholder perceptions, Administration for Children and
(410) 786–1326. experiences and expectations, provide Families
FOR FURTHER INFORMATION CONTACT: an early warning of issues with service,
Reports Clearance Office at (410) 786– Submission for OMB Review;
or focus attention on areas where
1326. Comment Request
communication, training or changes in
SUPPLEMENTARY INFORMATION: operations might improve delivery of Title: Administration for Native
products or services. These collections Americans Annual Data Collection
Contents
will allow for ongoing, collaborative and (Annual Data Report).
This notice sets out a summary of the actionable communications between the
use and burden associated with the Agency and its customers and OMB No.: New collection.
following information collections. More stakeholders. It will also allow feedback Description: Content and formatting
detailed information can be found in to contribute directly to the changes are being made to the Objective
each collection’s supporting statement improvement of program management. Progress Report (OPR). Content changes
and associated materials (see are being made to the OPR, now known
Collecting voluntary customer
ADDRESSES). as the Annual Data Report (ADR)
feedback is the least burdensome, most
CMS–10415 Generic Clearance for the effective way for the Agency to previously approved under information
Collection Customer Satisfaction determine whether or not its public Web collection OMB No. 0980–0204. ANA
Surveys sites are useful to and used by its has determined that the requirement for
customers. Generic clearance is needed ANA grantees to submit information
Under the PRA (44 U.S.C. 3501– about the project activities on quarterly
3520), federal agencies must obtain to ensure that the Agency can
continuously improve its Web sites basis creates undue burden for Grantees.
approval from the Office of Management Therefore, ANA has reformatted the
and Budget (OMB) for each collection of though regular surveys developed from
these pre-defined questions. Surveying OPR to require Grantees submit an
information they conduct or sponsor. annual report instead of quarterly report
The term ‘‘collection of information’’ is the Agency Web sites on a regular,
ongoing basis will help ensure that when reporting on partnerships, youth
defined in 44 U.S.C. 3502(3) and 5 CFR and elder engagement, impact
1320.3(c) and includes agency requests users have an effective, efficient, and
satisfying experience on any of the Web indicators, community involvement etc.
or requirements that members of the This will reduce the administrative
public submit reports, keep records, or sites, maximizing the impact of the
information and resulting in optimum burden on Grantees, especially the
provide information to a third party. smaller organizations. The majority of
Section 3506(c)(2)(A) of the PRA benefit for the public. The surveys will
ensure that this communication channel content being requested from the
requires federal agencies to publish a grantees essentially remain same except
60-day notice in the Federal Register meets customer and partner priorities,
builds the Agency’s brands, and for the frequency of reporting. The other
concerning each proposed collection of sections of the document with reference
information, including each proposed contributes to the Agency’s health and
human services impact goals. Form to ‘‘quarterly’’ information will be
extension or reinstatement of an existing changed to reflect the shift from four-
collection of information, before Number: CMS–10415 (OMB control
number: 0938–1185); Frequency: times a year reporting requirement to
submitting the collection to OMB for once per year and once at the end of the
approval. To comply with this Occasionally; Affected Public:
Individuals and Households, Business project period.
requirement, CMS is publishing this
notice. or other for-profits and Not-for-profit Respondents: Tribal Government,
institutions, State, Local or Tribal Native non-profit organizations, Tribal
Information Collection Governments; Number of Respondents: Colleges & Universities receiving ANA
1. Type of Information Collection 1,000,000; Total Annual Responses: funding.
Request: Extension of a currently 1,000,000; Total Annual Hours: 35,000. Annual Burden Estimates
approved collection; Title of (For policy questions regarding this
Information Collection: Generic collection contact John Booth at 410– The following is the hour of burden
Clearance for the Collection Customer 786–6577. estimate for this information collection:
Number of Average
Number of Total burden
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument responses per burden hours
respondents hours
respondent per response
ADR ................................................................................................................. 275 2 2 275
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![66906 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices
Estimated Total Annual Burden liposome drug products submitted in 2002–D–0093 (formerly docket ID
Hours: 275. new drug applications (NDAs), 2002D–0337) for ‘‘Liposome Drug
Additional Information: Copies of the abbreviated new drug applications Products: Chemistry, Manufacturing,
proposed collection may be obtained by (ANDAs), and biologics license and Controls; Human Pharmacokinetics
writing to the Administration for applications (BLAs) reviewed by the and Bioavailability; and Labeling
Children and Families, Office of Center for Drug Evaluation and Research Documentation.’’ Received comments
Planning, Research and Evaluation, 370 (CDER). will be placed in the docket and, except
L’Enfant Promenade SW., Washington, DATES: Although you can comment on for those submitted as ‘‘Confidential
DC 20447, Attn: ACF Reports Clearance any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
Officer. All requests should be 10.115(g)(5)), to ensure that the Agency http://www.regulations.gov or at the
identified by the title of the information considers your comment on this draft Division of Dockets Management
collection. Email address: guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
infocollection@acf.hhs.gov. final version of the guidance, submit through Friday.
OMB Comment: OMB is required to either electronic or written comments • Confidential Submissions—To
make a decision concerning the on the draft guidance by December 29, submit a comment with confidential
collection of information between 30 2015. information that you do not wish to be
and 60 days after publication of this ADDRESSES: You may submit comments made publicly available submit your
document in the Federal Register. as follows: comments only as a written/paper
Therefore, a comment is best assured of submission. You should submit two
having its full effect if OMB receives it Electronic Submissions copies total. One copy will include the
within 30 days of publication. Written Submit electronic comments in the information you claim to be confidential
comments and recommendations for the following way: with a heading or cover note that states
proposed information collection should • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
be sent directly to the following: Office www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
of Management and Budget, Paperwork instructions for submitting comments. Agency will review this copy, including
Reduction Project, Email: OIRA_ Comments submitted electronically, the claimed confidential information, in
SUBMISSION@OMB.EOP.GOV, Attn: including attachments, to http:// its consideration of comments. The
Desk Officer for the Administration for www.regulations.gov will be posted to second copy, which will have the
Children and Families. the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
Robert Sargis, solely responsible for ensuring that your for public viewing and posted on http://
Reports Clearance Officer. comment does not include any www.regulations.gov. Submit both
[FR Doc. 2015–27666 Filed 10–29–15; 8:45 am] confidential information that you or a copies to the Division of Dockets
BILLING CODE 4184–01–P third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
anyone else’s Social Security number, or made publicly available, you can
DEPARTMENT OF HEALTH AND confidential business information, such provide this information on the cover
HUMAN SERVICES as a manufacturing process. Please note sheet and not in the body of your
that if you include your name, contact comments and you must identify this
Food and Drug Administration information, or other information that information as ‘‘confidential.’’ Any
[Docket No. FDA–2002–D–0093 (Formerly identifies you in the body of your information marked as ‘‘confidential’’
Docket ID 2002D–0337)] comments, that information will be will not be disclosed except in
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Liposome Drug Products: Chemistry, • If you want to submit a comment applicable disclosure law. For more
Manufacturing, and Controls; Human with confidential information that you information about FDA’s posting of
Pharmacokinetics and Bioavailability; do not wish to be made available to the comments to public dockets, see 80 FR
and Labeling Documentation; Draft public submit the comment as a written/ 56469, September 18, 2015, or access
Guidance for Industry; Availability paper submission and in the manner the information at: http://www.fda.gov/
detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). default.htm.
HHS. Docket: For access to the docket to
ACTION: Notice of availability. Written/Paper Submissions read background documents or the
Submit written/paper submissions as electronic and written/paper comments
SUMMARY: The Food and Drug follows: received, go to http://
Administration (FDA) is announcing the • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
availability of a revised draft guidance written/paper submissions): Division of docket number, found in brackets in the
for industry entitled ‘‘Liposome Drug Dockets Management (HFA–305), Food heading of this document, into the
Products: Chemistry, Manufacturing, and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
and Controls; Human Pharmacokinetics Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
and Bioavailability; and Labeling • For written/paper comments Management, 5630 Fishers Lane, Rm.
Documentation.’’ This revised draft submitted to the Division of Dockets 1061, Rockville, MD 20852.
guidance document replaces the draft of Management, FDA will post your Submit written requests for single
tkelley on DSK3SPTVN1PROD with NOTICES
the same name that published on comment, as well as any attachments, copies of the draft guidance to the
August 21, 2002. This revised draft except for information submitted, Division of Drug Information, Center for
guidance provides recommendations to marked and identified, as confidential, Drug Evaluation and Research, Food
applicants on the chemistry, if submitted as detailed in and Drug Administration, 10001 New
manufacturing, and controls (CMC); ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
pharmacokinetics and bioavailability; Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
and labeling documentation for must include the Docket No. FDA– 0002. Send one self-addressed adhesive
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Document Created: 2015-12-14 15:29:06
Document Modified: 2015-12-14 15:29:06
| 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 | 80 FR 66905 |
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