80_FR_50457 80 FR 50297 - Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM) [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information Contact: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non- toll-free number (301) 402-9680, or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. There are no costs to respondents other than there their time. The total estimated annualized burden hours are 682,535."> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information Contact: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non- toll-free number (301) 402-9680, or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. There are no costs to respondents other than there their time. The total estimated annualized burden hours are 682,535." /> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information Contact: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non- toll-free number (301) 402-9680, or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. There are no costs to respondents other than there their time. The total estimated annualized burden hours are 682,535." />

80 FR 50297 - Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 160 (August 19, 2015)

Page Range50297-50298
FR Document2015-20473

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 10, 2015, page 32968 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information Contact: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non- toll-free number (301) 402-9680, or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. There are no costs to respondents other than there their time. The total estimated annualized burden hours are 682,535.

Federal Register, Volume 80 Issue 160 (Wednesday, August 19, 2015) 
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50297-50298]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20473]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Information 
Program on Clinical Trials: Maintaining a Registry and Results Databank 
(NLM)

    Summary: Under the provisions of Section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Institutes of Health 
(NIH) has submitted to the Office of Management and Budget (OMB) a 
request for review and approval of the information collection listed 
below. This proposed information collection was previously published in 
the Federal Register on June 10, 2015, page 32968 and allowed 60-days 
for public comment. One public comment was received. The purpose of 
this notice is to allow an additional 30 days for public comment. The 
National Library of Medicine (NLM), National Institutes of Health, may 
not conduct or sponsor, and the respondent is not required to respond 
to, an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.
    For Further Information Contact: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project contact: David Sharlip, Office of Administrative and 
Management Analysis Services, National Library of Medicine, Building 
38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-
toll-free number (301) 402-9680, or Email your request, including your 
address to: [email protected]. Formal requests for additional plans 
and instruments must be requested in writing.
    Proposed Collection: Information Program on Clinical Trials: 
Maintaining a Registry and Results Databank (NLM), 0925-0586, 
Expiration Date 08/31/2015, EXTENSION, National Library of Medicine 
(NLM), National Institutes of Health (NIH).
    Need and Use of Information Collection: The National Institutes of 
Health operates ClinicalTrials.gov, which was established as a clinical 
trial registry under section 113 of the Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include 
a results data bank by Title VIII of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects 
registration and results information for clinical trials and other 
types of clinical studies (e.g., observational studies and patient 
registries) with the objectives of enhancing patient enrollment and 
providing a mechanism for tracking subsequent progress of clinical 
studies, to the benefit of public health. It is widely used by 
patients, physicians, and medical researchers; in particular those 
involved in clinical research.

[[Page 50298]]

While many clinical studies are registered and submit results 
information voluntarily, FDAAA requires the registration of certain 
applicable clinical trials of drugs and devices and the submission of 
results information for completed applicable clinical trials of drugs 
and devices that are approved, licensed, or cleared by the Food and 
Drug Administration. Beginning in 2009, results information was 
required to include information about serious and frequent adverse 
events.
    This extension request does not include any changes to the 
information submission requirements for ClinicalTrials.gov that were 
proposed in the Notice of Proposed Rulemaking on Clinical Trial 
Registration and Results Submission that was issued on November 21, 
2014 and for which the public comment period closed on March 23, 2015 
(79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted 
public comments as it prepares the final rule. The NIH will make any 
corresponding changes to the ClinicalTrials.gov information collection 
via separate procedure.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than there their time. The total estimated annualized 
burden hours are 682,535.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
                 Submission type                     Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      hour burden
----------------------------------------------------------------------------------------------------------------
PRS Account.....................................           5,700               1           15/60           1,425
Initial Registration............................          23,000               1               7         161,000
Updates.........................................          23,000               8               2         368,000
Initial Results.................................           3,700               1              25          92,500
Updates.........................................           3,700               2               8          59,200
Certification to Delay Results..................             700               1           30/60             350
Extension Request...............................              30               1               2              60
----------------------------------------------------------------------------------------------------------------


    Dated: August 13, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015-20473 Filed 8-18-15; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50297 TABLE 2—FEES FOR ORIGINAL AND SUBSEQUENT EXPORT CERTIFICATES Type of certificate Fee (dollars) Original certificates (may be multiple in number) 1 ............................................................................................................. 175 All subsequent certificates issued for the same product(s) in response to the same request 1 ........................................ 85 1 As calculated under formula. Under its formula for calculating heading of this document. Received Direct Comments to OMB: Written applicable fees, CDRH has allowed comments may be seen in the Division comments and/or suggestions regarding multiple devices to be included in a of Dockets Management between 9 a.m. the item(s) contained in this notice, single certificate rather than requiring and 4 p.m., Monday through Friday, and especially regarding the estimated that each device have a separate will be posted to the docket at http:// public burden and associated response certificate for which a fee is charged. www.regulations.gov. time, should be directed to the: Office While CDRH will continue to allow of Management and Budget, Office of IV. The Paperwork Reduction Act of Regulatory Affairs, OIRA_submission@ multiple devices to be included in a single certificate, it is revising the 1995 omb.eop.gov or by fax to 202–395–6974, formula by which the number of This notice refers to previously Attention: NIH Desk Officer. original device export certificates (at approved collections of information. Comment Due Date: Comments $175 per certificate) and subsequent These collections of information are regarding this information collection are certificates (at $85 per certificate) will subject to review by the Office of best assured of having their full effect if be calculated. The number of original Management and Budget (OMB) under received within 30-days of the date of and subsequent device export the Paperwork Reduction Act of 1995 this publication. certificates will be calculated using a (44 U.S.C. 3501–3520). The collections For Further Information Contact: To revised formula that sets the maximum of information in sections 801(e) and obtain a copy of the data collection pages per certificate to 25 pages (the 802 of the FD&C Act have been plans and instruments or request more certificate page and a maximum of 24 approved under OMB control number information on the proposed project pages for any attachments). Previously, 0910–0498. contact: David Sharlip, Office of the maximum number of pages was 50. Dated: August 13, 2015. Administrative and Management If the request is more than 25 pages, Analysis Services, National Library of Leslie Kux, then the total number of pages created Medicine, Building 38A, Room B2N12, Associate Commissioner for Policy. 8600 Rockville Pike, Bethesda, MD by the request is divided by 25 and that [FR Doc. 2015–20429 Filed 8–18–15; 8:45 am] 20894, or call non-toll-free number (301) number will be the number of original certificates that will be charged at $175 BILLING CODE 4164–01–P 402–9680, or Email your request, and the remaining number of including your address to: sharlipd@ subsequent certificates will be charged mail.nih.gov. Formal requests for DEPARTMENT OF HEALTH AND additional plans and instruments must at $85 each. For example, if you request HUMAN SERVICES be requested in writing. 15 certificates and each certificate has 12 attachment pages plus the certificate Proposed Collection: Information National Institutes of Health Program on Clinical Trials: Maintaining page that means each certificate is 13 pages, and your request will generate Submission for OMB Review; 30-Day a Registry and Results Databank (NLM), 195 pages in all. This number of pages Comment Request; Information 0925–0586, Expiration Date 08/31/2015, is divided by 25 and that equals 7.8, Program on Clinical Trials: Maintaining EXTENSION, National Library of which is rounded to 8. Therefore, you a Registry and Results Databank (NLM) Medicine (NLM), National Institutes of will be charged for 8 original certificates Health (NIH). at $175 each and 7 subsequent Summary: Under the provisions of Need and Use of Information certificates at $85 each. Please note the Section 3507(a)(1)(D) of the Paperwork Collection: The National Institutes of maximum number of attachment pages Reduction Act of 1995, the National Health operates ClinicalTrials.gov, is 24 pages. If you have more than 24 Institutes of Health (NIH) has submitted which was established as a clinical trial pages you will need to split the request to the Office of Management and Budget registry under section 113 of the Food into two or more requests. (OMB) a request for review and and Drug Administration Modernization approval of the information collection Act of 1997 (Pub. L. 105–115) and was III. Request for Comments listed below. This proposed information expanded to include a results data bank Although the EREA does not require collection was previously published in by Title VIII of the Food and Drug FDA to solicit comments on the the Federal Register on June 10, 2015, Administration Amendments Act of assessment and collection of fees for page 32968 and allowed 60-days for 2007 (FDAAA). ClinicalTrials.gov export certificates, FDA is inviting public comment. One public comment collects registration and results comments from interested persons in was received. The purpose of this notice information for clinical trials and other order to have the benefit of additional is to allow an additional 30 days for types of clinical studies (e.g., views. public comment. The National Library observational studies and patient Interested persons may submit either of Medicine (NLM), National Institutes registries) with the objectives of tkelley on DSK3SPTVN1PROD with NOTICES electronic comments regarding this of Health, may not conduct or sponsor, enhancing patient enrollment and document to http://www.regulations.gov and the respondent is not required to providing a mechanism for tracking or written comments to the Division of respond to, an information collection subsequent progress of clinical studies, Dockets Management (see ADDRESSES). It that has been extended, revised, or to the benefit of public health. It is is only necessary to send one set of implemented on or after October 1, widely used by patients, physicians, comments. Identify comments with the 1995, unless it displays a currently valid and medical researchers; in particular docket number found in brackets in the OMB control number. those involved in clinical research. VerDate Sep<11>2014 19:14 Aug 18, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1

50298 Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices While many clinical studies are about serious and frequent adverse NIH is continuing to review submitted registered and submit results events. public comments as it prepares the final information voluntarily, FDAAA This extension request does not rule. The NIH will make any requires the registration of certain include any changes to the information corresponding changes to the applicable clinical trials of drugs and submission requirements for ClinicalTrials.gov information devices and the submission of results ClinicalTrials.gov that were proposed in collection via separate procedure. information for completed applicable the Notice of Proposed Rulemaking on clinical trials of drugs and devices that Clinical Trial Registration and Results OMB approval is requested for 3 are approved, licensed, or cleared by the Submission that was issued on years. There are no costs to respondents Food and Drug Administration. November 21, 2014 and for which the other than there their time. The total Beginning in 2009, results information public comment period closed on March estimated annualized burden hours are was required to include information 23, 2015 (79 FR 225, Nov. 21, 2014). The 682,535. ESTIMATED ANNUALIZED BURDEN HOURS Number of Average time Number of Total annual Submission type responses per per response respondents hour burden respondent (in hours) PRS Account ................................................................................................... 5,700 1 15/60 1,425 Initial Registration ............................................................................................ 23,000 1 7 161,000 Updates ............................................................................................................ 23,000 8 2 368,000 Initial Results ................................................................................................... 3,700 1 25 92,500 Updates ............................................................................................................ 3,700 2 8 59,200 Certification to Delay Results .......................................................................... 700 1 30/60 350 Extension Request ........................................................................................... 30 1 2 60 Dated: August 13, 2015. practical utility; (2) The accuracy of the Proposed Collection: National David Sharlip, agency’s estimate of the burden of the Toxicology Program Level of Concern Project Clearance Liaison, NLM, NIH. proposed collection of information, Categories, 0925–NEW, National [FR Doc. 2015–20473 Filed 8–18–15; 8:45 am] including the validity of the Institute of Environmental Health BILLING CODE 4140–01–P methodology and assumptions used; (3) Sciences (NIEHS), National Institutes of Ways to enhance the quality, utility, and Health (NIH). clarity of the information to be Need and Use of Information DEPARTMENT OF HEALTH AND collected; and (4) Ways to minimize the Collection: The National Toxicology HUMAN SERVICES burden of the collection of information Program (NTP) has used a 5-point level on those who are to respond, including of concern (LoC) framework to National Institutes of Health the use of appropriate automated, communicate NTP’s assessment of the electronic, mechanical, or other degree of concern regarding the Proposed Collection; 60-Day Comment technological collection techniques or potential human health effects of Request; National Toxicology Program other forms of information technology. selected substances given what is (NTP) Level of Concern Categories To Submit Comments and for Further known about their toxicity, level of Study (NIEHS) Information: To obtain a copy of the human exposure, and pharmacokinetics. Summary: In compliance with the data collection plans and instruments, As part of its systematic review requirement of Section 3506(c)(2)(A) of submit comments in writing, or request methodologies, the NTP is updating its the Paperwork Reduction Act of 1995, more information on the proposed LoC framework to enhance transparency for opportunity for public comment on project, contact: Dr. Kristina Thayer, in what the LoC categories mean, proposed data collection projects, the Director of the Office of Health describing the factors considered in National Institute of Environmental Assessment and Translation, Division of reaching conclusions and identifying Health Sciences (NIEHS), National National Toxicology Program, NIEHS, strategies for improving their use as a Institutes of Health (NIH), will publish P.O. Box 12233, Mail Drop K2–04, risk communication tool. This study periodic summaries of proposed Research Triangle Park, NC 27709, or will use expert solicitation from five projects to be submitted to the Office of call non-toll-free number (919) 541– NTP stakeholder sectors (academia, Management and Budget (OMB) for 5021, or Email your request, including industry, non-government review and approval. your address to: thayer@niehs.nih.gov. organizations, and federal and state Written comments and/or suggestions Formal requests for additional plans and agencies) to aid in determining the from the public and affected agencies instruments must be requested in optimal number of LoC categories for an are invited on one or more of the writing. updated LoC framework. following points: (1) Whether the Comment Due Date: Comments OMB approval is requested for 3 proposed collection of information is regarding this information collection are years. There are no costs to respondents necessary for the proper performance of best assured of having their full effect if other than their time. The total the function of the agency, including received within 60 days of the date of estimated annualized burden hours are tkelley on DSK3SPTVN1PROD with NOTICES whether the information will have this publication. 300. VerDate Sep<11>2014 19:14 Aug 18, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\19AUN1.SGM 19AUN1


Document Created: 2015-12-15 11:58:27
Document Modified: 2015-12-15 11:58:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
ContactTo obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non- toll-free number (301) 402-9680, or Email your request, including your
FR Citation80 FR 50297 
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