80 FR 63797 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 203 (October 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 203 (October 21, 2015)
| Page Range | 63797-63799 | |
| FR Document | 2015-26673 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Notices] [Pages 63797-63799] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26673] [[Page 63797]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0372] Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by our Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information and to allow 60 days for public comment. This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). DATES: Submit either electronic or written comments on the collection of information by December 21, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2007-D-0372 for the information collection request entitled, ``Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the DSNDCPA.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. [[Page 63798]] Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the DSNDCPA, 21 U.S.C. 379aa-1(b)(1) OMB Control Number 0910-0635--Extension The DSNDCPA (Pub. L. 109-462) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious adverse event reporting and recordkeeping for dietary supplements and non- prescription drugs marketed without an approved application. Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires the manufacturer, packer, or distributor whose name under section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed in the United States to submit to us all serious adverse event reports associated with the use of a dietary supplement, accompanied by a copy of the product label. The manufacturer, packer, or distributor of a dietary supplement is required by the DSNDCPA to use the MedWatch form (Form FDA 3500A) when submitting a serious adverse event report to FDA. In addition, under section 761(c)(2) of the FD&C Act, the submitter of the serious adverse event report (referred to in the statute as the ``responsible person'') is required to submit to FDA a follow up report of any related new medical information the responsible person receives within 1 year of the initial report. Section 761(e)(1) of the FD&C Act requires that responsible persons maintain records related to the dietary supplement adverse event reports they receive, whether or not the adverse event is serious. Under the statute, the records must be retained for a period of 6 years. As required by section 3(d)(3) of the DSNDCPA, we issued guidance to describe the minimum data elements for serious adverse event reports for dietary supplements. In the Federal Register of July 14, 2009 (74 FR 34024), we announced the availability of guidance entitled ``Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The guidance discusses how, when, and where to submit serious adverse event reports for dietary supplements and followup reports. The guidance also provides our recommendation on records maintenance and access for serious and non-serious adverse event reports and related documents. The guidance recommends that the responsible person document their attempts to obtain the minimum data elements for a serious adverse event report. Along with these records, the guidance recommends that the responsible person keep the following other records: (1) Communications between the responsible person and the initial reporter of the adverse event and between the responsible person and any other person(s) who provided information about the adverse event; (2) the responsible person's serious adverse event report to us with attachments; (3) any new information about the adverse event received by the responsible person; (4) any reports to us of new information related to the serious adverse event report. We estimate the annual reporting burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 U.S.C. section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 21 U.S.C. 379aa-1(b)(1)--serious 170 17 2,860 2 5,720 adverse event reports for dietary supplements............ 21 U.S.C. 379aa-1(c)(2)-- 42 17 715 1 715 followup reports of new medical information.................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 6,435 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. This estimate is based on our experience with similar adverse event reporting programs and the number of serious adverse event reports and followup reports received in the past 3 years. All dietary supplement manufacturers, packers, or distributors are subject to serious adverse event mandatory reporting. We received 2,435 initial serious adverse event reports in fiscal year (FY) 2012, 3,414 in FY2013, and 2,745 in FY2014. We averaged these figures (2,860 rounded to the nearest 10) as a basis for our estimated number of annual reports. We also used an average of the number of firms filing reports (170 rounded to the nearest 10). Finally, we estimate that it will take respondents an average of 2 hours per report to collect information about a serious adverse event associated with a dietary supplement and report the information to us on Form FDA 3500A. Thus, the estimated burden associated with submitting initial dietary supplement serious adverse event reports is 5,720 hours (2,860 responses x 2 hours) as shown in row 1 of Table 1. If a respondent that has submitted a serious adverse event report receives new information related to the serious adverse event within 1 year of submitting the initial report, the respondent must provide the new information to us in a followup report. We estimate that 25 percent of serious adverse event reports related to dietary supplements will have a followup report submitted, resulting in approximately 715 followup reports submitted annually (2,860 x 0.25 = 715). Dividing the annual number of reports among the 170 firms reporting results in approximately 17 reports for 42 respondents. We estimate that each followup report will require an hour to assemble and submit, including the time needed to copy and attach the initial serious adverse event report as recommended in the guidance. Thus the estimated burden for followup reports of new information is 715 hours (715 responses x 1 hour) as shown in row 2 of Table 1. [[Page 63799]] Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 U.S.C. section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Dietary supplement adverse event records 1,700 74 125,800 0.5 (30 minutes)........................ 62,900 (21 U.S.C. 379aa-1(e)(1)). -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. All dietary supplement manufacturers, packers, or distributors are subject to serious adverse event recordkeeping. We estimate that there are 1,700 such respondents, based on the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR 34751) on the ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,'' and factoring a two percent annual growth rate. Estimating that each recordkeeper will keep approximately 74 records per year results in an annual burden of 125,800 records. Estimating that assembling and filing these records, including any necessary photocopying, will take approximately 30 minutes, or 0.5 hours, per record, results in an annual burden of 62,900 hours (125,800 records x 0.50 hours = 62,900 total hours. Once the documents pertaining to an adverse event report have been assembled and filed in accordance with the safety reporting portal, we expect the records retention burden to be minimal, as we believe most establishments would normally keep this kind of record for at least several years after receiving the report, as a matter of usual and customary business practice. Dated: October 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26673 Filed 10-20-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices 63797
DEPARTMENT OF HEALTH AND • If you want to submit a comment applicable disclosure law. For more
HUMAN SERVICES with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
Food and Drug Administration public, submit the comment as a 56469, September 18, 2015, or access
[Docket No. FDA–2007–D–0372] written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Agency Information Collection Submissions’’ and ‘‘Instructions’’). default.htm.
Activities; Proposed Collection; Docket: For access to the docket to
Written/Paper Submissions read background documents or the
Comment Request; Adverse Event
Reporting and Recordkeeping for Submit written/paper submissions as electronic and written/paper comments
Dietary Supplements as Required by follows: received, go to http://
the Dietary Supplement and • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Nonprescription Drug Consumer written/paper submissions): Division of docket number, found in brackets in the
Protection Act Dockets Management (HFA–305), Food heading of this document, into the
and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
HHS. • For written/paper comments Management, 5630 Fishers Lane, Rm.
ACTION: Notice. submitted to the Division of Dockets 1061, Rockville, MD 20852.
Management, FDA will post your
SUMMARY: The Food and Drug FOR FURTHER INFORMATION CONTACT: FDA
comment, as well as any attachments,
Administration (FDA or we) is PRA Staff, Office of Operations, Food
except for information submitted,
announcing an opportunity for public and Drug Administration, 8455
marked and identified, as confidential,
comment on the proposed collection of Colesville Rd., COLE–14526, Silver
if submitted as detailed in
certain information by our Agency. Spring, MD 20993–0002, PRAStaff@
‘‘Instructions.’’
Under the Paperwork Reduction Act of Instructions: All submissions received fda.hhs.gov.
1995 (the PRA), Federal Agencies are must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
required to publish notice in the 2007–D–0372 for the information PRA (44 U.S.C. 3501–3520), Federal
Federal Register concerning each collection request entitled, ‘‘Adverse Agencies must obtain approval from the
proposed collection of information Event Reporting and Recordkeeping for Office of Management and Budget
including each proposed extension of an Dietary Supplements as Required by the (OMB) for each collection of
existing collection of information and to DSNDCPA.’’ information they conduct or sponsor.
allow 60 days for public comment. This Received comments will be placed in ‘‘Collection of information’’ is defined
notice solicits comments on the the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
collection of information associated submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
with adverse event reporting and Submissions,’’ publicly viewable at or requirements that members of the
recordkeeping for dietary supplements http://www.regulations.gov or at the public submit reports, keep records, or
as required by the Dietary Supplement Division of Dockets Management provide information to a third party.
and Nonprescription Drug Consumer between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
Protection Act (the DSNDCPA). through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
DATES: Submit either electronic or • Confidential Submissions—To Agencies to provide a 60-day notice in
written comments on the collection of submit a comment with confidential the Federal Register concerning each
information by December 21, 2015. information that you do not wish to be proposed collection of information,
ADDRESSES: You may submit comments made publicly available, submit your including each proposed extension of an
as follows: comments only as a written/paper existing collection of information,
submission. You should submit two before submitting the collection to OMB
Electronic Submissions copies total. One copy will include the for approval. To comply with this
Submit electronic comments in the information you claim to be confidential requirement, we are publishing this
following way: with a heading or cover note that states notice of the proposed collection of
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The With respect to the following
instructions for submitting comments. Agency will review this copy, including collection of information, we invite
Comments submitted electronically, the claimed confidential information, in comments on these topics: (1) Whether
including attachments, to http:// its consideration of comments. The the proposed collection of information
www.regulations.gov will be posted to second copy, which will have the is necessary for the proper performance
the docket unchanged. Because your claimed confidential information of FDA’s functions, including whether
comment will be made public, you are redacted/blacked out, will be available the information will have practical
solely responsible for ensuring that your for public viewing and posted on http:// utility; (2) the accuracy of FDA’s
comment does not include any www.regulations.gov. Submit both estimate of the burden of the proposed
confidential information that you or a copies to the Division of Dockets collection of information, including the
third party may not wish to be posted, Management. If you do not wish your validity of the methodology and
such as medical information, your or name and contact information to be assumptions used; (3) ways to enhance
anyone else’s Social Security number, or made publicly available, you can the quality, utility, and clarity of the
tkelley on DSK3SPTVN1PROD with NOTICES
confidential business information, such provide this information on the cover information to be collected; and (4)
as a manufacturing process. Please note sheet and not in the body of your ways to minimize the burden of the
that if you include your name, contact comments and you must identify this collection of information on
information, or other information that information as ‘‘confidential.’’ Any respondents, including through the use
identifies you in the body of your information marked as ‘‘confidential’’ of automated collection techniques,
comments, that information will be will not be disclosed except in when appropriate, and other forms of
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other information technology.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden
21 U.S.C. section records per Total hours
recordkeepers records per recordkeeping
recordkeeper
Dietary supplement adverse event records (21 1,700 74 125,800 0.5 (30 minutes) ........ 62,900
U.S.C. 379aa–1(e)(1)).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
All dietary supplement ACTION: Notice. related to tobacco use. Accordingly,
manufacturers, packers, or distributors FDA is currently developing and
are subject to serious adverse event SUMMARY: The Food and Drug implementing public education
recordkeeping. We estimate that there Administration (FDA) is announcing campaigns to help prevent and reduce
are 1,700 such respondents, based on that a proposed collection of tobacco use among lesbian, gay,
the figure 1,460 as provided in our final information has been submitted to the bisexual, and transgender (LGBT) young
rule of June 25, 2007 (72 FR 34751) on Office of Management and Budget adults and thereby reduce the public
the ‘‘Current Good Manufacturing (OMB) for review and clearance under health burden of tobacco. Overall the
Practice in Manufacturing, Packaging, the Paperwork Reduction Act of 1995. campaigns will feature events;
Labeling, or Holding Operations for DATES: Fax written comments on the advertisements on television and radio
Dietary Supplements,’’ and factoring a collection of information by November and in print; digital communications
two percent annual growth rate. 20, 2015. including social media; and other forms
Estimating that each recordkeeper will ADDRESSES: To ensure that comments on of media.
keep approximately 74 records per year the information collection are received, In support of the provisions of the
results in an annual burden of 125,800 OMB recommends that written Tobacco Control Act that require FDA to
records. Estimating that assembling and comments be faxed to the Office of protect the public health and to reduce
filing these records, including any Information and Regulatory Affairs, tobacco use, FDA requests OMB
necessary photocopying, will take OMB, Attn: FDA Desk Officer, FAX: approval to collect information needed
approximately 30 minutes, or 0.5 hours, 202–395–7285, or emailed to oira_ to evaluate FDA’s campaign to reduce
per record, results in an annual burden submission@omb.eop.gov. All tobacco use among LGBT young adults.
of 62,900 hours (125,800 records × 0.50 comments should be identified with the Comprehensive evaluation of FDA’s
hours = 62,900 total hours. title ‘‘Evaluation of the Food and Drug public education campaigns is needed
Once the documents pertaining to an Administration’s Campaign to Reduce to ensure campaign messages are
adverse event report have been Tobacco Use Among Lesbian, Gay, effectively received, understood, and
assembled and filed in accordance with Bisexual, and Transgender Young accepted by those for whom they are
the safety reporting portal, we expect Adults’’. Also include the FDA docket intended. Evaluation is an essential
the records retention burden to be number found in brackets in the organizational practice in public health
minimal, as we believe most heading of this document. and a systematic way to account for and
establishments would normally keep FOR FURTHER INFORMATION CONTACT: FDA improve public health actions.
this kind of record for at least several PRA Staff, Office of Operations, Food FDA plans to conduct two studies to
years after receiving the report, as a and Drug Administration, 8455 evaluate the effectiveness of its LGBT
matter of usual and customary business Colesville Rd., COLE–14526, Silver young adult tobacco prevention
practice. Spring, MD 20993–0002, PRAStaff@ campaign: (1) An outcome evaluation
fda.hhs.gov. study to evaluate the effectiveness of its
Dated: October 15, 2015.
SUPPLEMENTARY INFORMATION: In LGBT young adult tobacco prevention
Leslie Kux,
compliance with 44 U.S.C. 3507, FDA campaign, and (2) a media tracking
Associate Commissioner for Policy. questionnaire to assess awareness of and
has submitted the following proposed
[FR Doc. 2015–26673 Filed 10–20–15; 8:45 am] receptivity to campaign messages. The
collection of information to OMB for
BILLING CODE 4164–01–P review and clearance. timing of these studies will be designed
to follow the multiple, discrete waves of
Evaluation of FDA’s Campaign To media advertising planned for the
DEPARTMENT OF HEALTH AND Reduce Tobacco Use Among Lesbian, campaigns.
HUMAN SERVICES Gay, Bisexual, and Transgender Young
Adults—OMB Control Number 0910— I. Outcome Evaluation Study
Food and Drug Administration New Before the beginning of data
The 2009 Family Smoking Prevention collection for the outcome evaluation
[Docket No. FDA–2015–N–2126] and Tobacco Control Act (Tobacco study, the 5-minute screening
Agency Information Collection Control Act) (Pub. L. 111–31) amended instrument will be tested in a small
Activities; Submission for Office of the Federal Food, Drug, and Cosmetic pilot study of LGBT young adults aged
Management and Budget Review; Act (the FD&C Act) to grant FDA 18 to 24. The outcome evaluation study
Comment Request; Evaluation of the authority to regulate the manufacture, will then begin with a baseline survey
tkelley on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration’s marketing, and distribution of tobacco of LGBT young adults aged 18 to 24
Campaign To Reduce Tobacco Use products to protect public health and to before the campaign launch. The
Among Lesbian, Gay, Bisexual, and reduce tobacco use by minors. Section baseline will be followed by three
Transgender Young Adults 1003(d)(2)(D) of the FD&C Act (21 followup surveys of the target audience
U.S.C. 393(d)(2)(D)) supports the of young adults at approximately 6-
AGENCY: Food and Drug Administration, development and implementation of month intervals after the campaign’s
HHS. FDA public education campaigns launch. Information will be collected
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Document Created: 2018-02-27 08:53:55
Document Modified: 2018-02-27 08:53:55
| 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 | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by December 21, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 63797 |
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